Mirena® was approved by the FDA on December 6th, 2000. It is a small piece of plastic depicted in the picture to the left. The device releases the hormone levonorgestrel in a quantity sufficient to prevent pregnancy. The device is effective for about five years, after which time it must be removed.
More than 2 million women in the United States use Mirena, and about 15 million women worldwide use the device. Mirena is marketed for women who have already had at least one child.
Like all intrauterine devices (IUD’s) it is very effective in preventing pregnancy. But Mirena may be more likely than other IUD’s to dislocate or move after it has been implanted. The medical term for this is migration.
When the Mirena device migrates, it may may puncture the uterus. The medical term for that is perforation. A perforated uterus is a very serious injury that can lead to infection, sterility, and even death.
How Mirena Works
The United States Department of Health and Human Services explains that Mirena and other intrauterine contraceptive devices function in the following way:
“An IUD is placed through your vagina and cervix and into your uterus by a health care provider. The ParaGard IUD will prevent pregnancy right away. It may take a week for the Mirena or Skyla IUD to begin working, so ask if you need to use a back-up birth control method (like a condom) in the meantime.
Once in place, ParaGard IUDs are effective for 10 years or more. The Mirena IUD will last for at least five years and the Skyla IUD for three years. But any IUD can be taken out at any time. Just ask your healthcare provider.
It is common for women to have some mild discomfort, cramping, and spotting after the IUD is first inserted. In most cases, this will become milder or go away in a few weeks or months. Ask your health care provider about what types of symptoms you should expect.
Your health care provider may also ask you to check your IUD strings on your own between visits to make sure they can be felt in your vagina. They will tell you more about how to do this.
Very rarely, an IUD may come out of your uterus on its own. This is more common in women who have never had a baby. If the IUD comes out, do not try to put it back yourself. Call your healthcare provider and they will insert another one for you.”
Mirena and Uterine Perforation
All IUD devices carry with them some risk of uterine perforation. But the Journal of Medical Case Reports published a study in 2009 which stated that Mirena is three times as likely to perforate a uterus than other IUD devices. For this reason alone, women who suffered from a perforated uterus while using Mirena may be eligible for a substantial settlement in a Mirena lawsuit.
Mirena and its Impact on Quality of Life
July 1st, 2013
Recently, the post-operative safety of levonorgestrel-releasing intrauterine systems (LNG-IUS), such as Mirena, was evaluated, LNG-IUS migration being the primary concern. Aside from common surgical complications, there have been numerous Mirena lawsuits filed because of the suffering caused by Mirena migration. Another possible side-effect of LNG-IUS use is the reduction of menstrual bleeding; often times deemed a positive unplanned effect.A recent study highlighted a concern associated with the use of LNG-IUSs, namely, that most patients do not receive proper pre-operative counseling, to indicate the possible side effects. This lack of preparatory counseling allows for the possibility of stress induced by the changes that occur to the patient’s body following the insertion of LNG-IUSs. These unexpected changes, while sometimes referred to as having a positive impact on the patient’s life are a source of unwanted and unexpected stress, which in-part, can lead to further, more serious complications if untreated.
Surgical Management of IUD Migration
June 24th, 2013An article from Ronit Haimov-Kochman et. al. studied the effects of levonorgestrel-releasing intrauterine systems (LNG-IUS), such as Mirena, on the plasma LNG levels of patients who have received LNG-IUSs. The study aimed at determining if the plasma LNG levels were significantly higher in women who received the device only to later have it removed due to choice or because of complications caused by the device, such as intrauterine device migration. Levonorgestrel (LNG) is the chemical that suppresses ovulation, making it an effective chemical to prevent unwanted pregnancy. However, if plasma LNG levels are too high following the removal of LNG-IUS devices, then ovulation may properly return in the patient, leading to unwanted pregnancy prevention.
The researchers determined that while LNG-IUSs had a high success rate for safe and effective removal of dislocated or migrated LNG-IUSs, they left the plasma LNG levels up to ten times higher than the levels observed with LNG-IUSs placed in utero. This study gives rise to the important concern about the risks involved in the use of LNG-IUS devices that pose the possibility of device migration because despite the possibility of removing migrated devices, the trace levonorgestrel left in the plasma of patients can lead to an unwanted halt in ovulation following removal.
IUD Requires Surgical Removal
June 24th, 2013
Mirena migration is known to be a serious complication soon after or even years after insertion of a Mirena device. The symptoms of such migration include intense abdominal pain, internal hemorrhaging, and organ damage. A recent study from Arie Bitterman et. al. discussed the method of laparoscopic removal of IUDs that have migrated to the extent of perforating the colon.
The study determined that laparoscopic approach to the removal of migrated IUDs was a safe and effective method for removing devices. The study did however determine that while this method appears to be a viable approach to migrated IUD removal, it does not guarantee an elimination of the risks of abdominal complications the condition presents. So despite the effectiveness of this approach to removal, there still lies the risk of further complications caused by migrated IUDs. Bitterman’s study shows that IUDs, such as Mirena are known to pose the potential threat of serious complications, including but not limited to perforation of interior walls, otherwise known as IUD migration. The study further showed that while methods like the laparoscopic method are effective in successfully removing migrated IUDs, they do not ensure that further complications will not occur.
Cancer Linked to Mirena Use
June 20th, 2013
While levonorgestrel-releasing intrauterine systems, such as Bayer Pharmaceutical’s Mirena®, are commonly considered the most effective intrauterine contraceptive, devices such as Mirena® also pose a serious threat to their users. Consequently, Mirena® lawsuits are often filed after complications arise due to improper insertion of the contraceptive such as uterine perforation, migration, and ectopic pregnancy. However, a recent study published by J. Abu et al. (2006) shows that the threat of endometrial cancer is known to be apparent even in the proper placement of Mirena®.The main presentation for the patient described in the study was irregular vaginal bleeding, which is a common finding in women who use this form of contraception. While the study concludes that Mirena® still is often times a safe and adequate contraception, the researchers suggest that the risks are high, given that cancer is a distinct possibility due to the use of Mirena and the symptoms of this side effect are difficult to discover.
Intrauterine Contraceptive Device Migration
May 30th, 2013
A recent article published in Archives of Gynecology and Obstetrics has shown that intrauterine contraceptive devices such as Mirena® inserted by those without adequate training and certification are more likely to perforate the uterus and migrate to the abdomen. While this may seem intuitive, it is a potentially-important consideration, given the increasing problem of IUD migration. To read the original research detailing surgical management procedures for mislocated intrauterine contraceptive devices, access the 2010 article by Osman Balci et al. online.Recently, it has become widely-documented that the most popular intrauterine contraceptive device in the United States, Mirena®, will tear through the uterine wall and migrate out of the uterus about 2.6 times per 1000 IUD insertions. For more information on the risk of Mirena® use, follow the link above.
Reuters – “Judge calls for female lawyers on plaintiffs’ committee in Mirena MDL”
May 22nd, 2013
As reported by Reuters, a New York judge overseeing a number of lawsuits filed against Bayer AG due to improper warnings about the danger of the Mirena® intrauterine contraceptive device, has asked that a committee of plaintiffs filing the lawsuits include more female lawyers, “given the nature of the litigation.”
The current lawsuits against Bayer AG regarding the Mirena® intrauterine contraceptive device results from a myriad of medical research demonstrating with a high degree of certainty the danger of this IUD: this levonorgestrel-releasing intrauterine contraceptive device may tear through the uterine wall (perforate) and migrate into other parts of the body, such as the abdomen, where it may adhere to other internal organs and in some cases tear into other internal organs. Mirena® migration always requires surgery to correct, and may take years to detect.
Reuters writes that, “In addition to the federal lawsuits, there are at least 113 cases consolidated in New Jersey state court before Judge Brian Martinotti, and a handful of cases in Missouri, New York, California and Mississippi state courts. In their position statement, the plaintiffs’ lawyers said they expected thousands of cases to eventually be filed in the multidistrict litigation.And, “All of the plaintiffs in the multidistrict litigation accuse Bayer of failing to adequately warn of the risk of perforation and migration. They contend that Bayer’s label and other warnings only informed of the risk of perforation during the insertion, not that the device could spontaneously migrate after a successful insertion.
“Bayer claims that since introducing the device in 2001, the company has warned of the risk of perforation and cautioned doctors and patients to monitor its placement by checking for threads attached to the device. What’s more, even if Bayer had provided a stronger warning, doctors would likely have prescribed the device anyway, the company contends, given that they learn of the perforation risks associated with all IUDs in their medical training.”
FDA Requires Warning Label Update for Mirena
March 21st, 2013
In May of 2008, the United States Food and Drug Administration required that the warning label for Bayer Pharmaceutical’s Mirena intrauterine contraceptive device be updated to include information regarding the risk for uterine perforation and Mirena migration as a result of then-recent research.Read the FDA-mandated warning update for Mirena here.Currently, Mirena is the world’s most popular intrauterine contraceptive device. About 2.6 in every 1000 Mirena insertions have been found to perforate the uterus, but that is not the only major issue with the device. Ectopic pregnancy – pregnancy that occurs outside the uterus – is a rare, but very serious complication associated with Mirena use. Ectopic pregnancy is a life-threatening condition for the mother, and sadly, is a situation that a developing fetus cannot survive.
Migrated Mirena Device Tears into Colon
March 21st, 2013
In 2010, Dr.’s Angie R. Taras and Jedediah A. Kaufman published an article titled “Laparoscopic Retrieval of Intrauterine Device Perforating the Sigmoid Colon,” a piece that reviews the case of a woman in whom an intrauterine contraceptive device tore through the uterine wall and entered the abdominal cavity where it perforated (tore into) the wall of the sigmoid colon.This woman was 36 years old at the time she came to hospital reporting “abdominal pain and bright red blood per rectum.” She had used an IUD for four years before this occurrence and until the time she came to hospital, she had not reported any experienced complications relating to the use of her contraceptive device.When she came to her doctor and the removal strings of the IUD were unable to be located and ultrasound confirmed that the uterine cavity was empty, computed tomography was ordered. Thankfully, computed tomography was able to locate the device and it was determined that the device had torn through the uterine wall, and while in the abdominal cavity had torn into the sigmoid colon. This allowed doctors to make a clear explanation of the pain the woman was experiencing, and it was recommended that the device be removed.For the removal of the device, laparoscopy was ordered – a minimally invasive surgical procedure involving the insertion of a tiny camera aboard surgical equipment for increased visualization of internal cavities. Thankfully, the woman’s surgery went well and she made a full recovery without further complication.
Taras, AR & Kaufman, JA (2010) “Laparoscopic Retrieval of Intrauterine Device Perforating the Sigmoid Colon” Journal of the Society of Laparoendoscopic Surgeons Vol. 14; pp. 453-455
Mirena Removal Methods After Migration Reviewed in 37 Women
March 21st, 2013
Published in the March 2012 edition of Contraception, an article titled “Ultrasound-guided hysteroscopy to remove a levonorgestrel intrauterine system in early pregnancy” by medical researcher Elizabeth A. McCarthy et al. reviews the efficacy of ultrasound-guided laparoscopy in the removal of migrated intrauterine contraceptive devices (IUDs).
Uterine perforation caused by intrauterine contraceptive devices is a rare, but serious complication of intrauterine contraceptive device use. About 2.6 in every thousand IUD insertions results in uterine perforation. Subsequent migration of intrauterine contraceptive devices to other places in the body cavity also constitutes a serious problem, as once intrauterine contraceptive devices migrate they may become adhered to or tear into other internal organs.
The McCarthy et al (2012) article reviewed the procedures used to remove Mirena® brand intrauterine contraceptive devices in 37 women in whom IUDs perforated the uterus, migrated into the abdomen, and required surgery for removal. The main issue that this publication addresses is the removal of migrated IUDs in women who have become pregnant as a result of the inefficacy of the translocated device.Because conception in the presence of an IUD has been associated with congenital anomalies (6-11%, compared with normal rates of 3-5%), the detection of translocated intrauterine contraceptive devices prior to conception is of utmost importance.
The authors of this article argue that the most safe, least invasive, and most effective means of removing a translocated intrauterine contraceptive device is laparoscopy, guided by ultrasound. Though X-ray may be, and is frequently used as a means to locate a migrated IUD, ultrasound is less dangerous for a developing fetus. Laparoscopy is a surgical procedure involving the insertion of a tiny camera aboard surgical equipment, allowing greater visualization of internal cavities than other methods.
Mirena Device Punctures Wall of Colon
March 14th, 2013
Recently, a Korean medical research team lead by Jung Min Park published an article describing the case of a woman in whom her levonorgestrel-releasing intrauterine contraceptive device (IUD) perforated the uterine wall, migrated to the abdomen, and penetrated the wall of the descending colon.This woman was 42 years old when she came to the hospital citing “pain in the lower abdomen that had started three months earlier.” Five years before this hospital visit, the patient was fitted with a levonorgestrel-releasing intrauterine contraceptive device without complication at insertion. Using X-ray and colonoscopic examination, the IUD was found to have punctured the wall of the descending colon.To remove the device, endoscopic retrieval was attempted but failed. With the patient in severe pain and the device unable to be removed, doctors decided to perform laparoscopy for removal. Laparoscopy is a surgical procedure using a tiny camera inserted into the body aboard surgical equipment through a small port. This minimally invasive procedure is used widely in the removal of translocated intrauterine contraceptive devices.
Other than the damage to the descending colon and a slight degree of scarring of the uterus, no other damage caused by the migrated IUD was observed. Fortunately, the patient recovered well after surgery.Sadly, however, perfect recovery after surgery is not always the case, and many women face the risk of IUD migration and uterine perforation unknowingly. Bayer Pharmaceuticals, the manufacturer of the world’s most popular IUD – Mirena® – has repeatedly failed to warn users of all risks associated with its product.
Mirena Device Migrates to the Pelvis after Tearing the Uterus
March 14th, 2013
In 2012, medical researchers Jashoman Banerjee et al. reported upon the unfortunate case of a woman in whom a Mirena® intrauterine contraceptive device (IUD) tore (perforated) the uterine wall and migrated to the left side of the pelvis.
This woman was 35 years old when her annual checkup with gynecologist could not locate the removal strings of her Mirena® device. When pelvic ultrasound confirmed the extrauterine presence of her IUD but could not establish its precise location, her gynecologist recommended an X-ray and the woman was taken to the hospital.After two diagnostic laparoscopy procedures – laparoscopy is a surgical procedure in which a tiny camera is inserted into the bodily cavity either simply for greater visualization of internal cavities, as was the case here, or for surgical performance – the precise location of the IUD was determined and doctors concluded that the device must be removed.For the removal of the migrated Mirena device, laparoscopy was used a third time, and once the adhesions of the device and the omentum were severed, the IUD was able to be removed. Thankfully, no damage to the bowel was observed. After the 35-minute surgery, the woman recovered well without complication.
While uterine perforation and IUD migration is rare (about 2.6 per 1000 IUD insertions results in migration), it is nonetheless a dangerous complication associated with Mirena use, and sadly is a complication that many women may face unknowingly, for the manufacturer of Mirena® has time and again failed to make adequate warnings of these dangers to its users.
Two Mirena Devices Migrate in Young Woman
March 13th, 2013
Recently, an article was published in The European Journal of Contraception and Reproductive Health Care detailing the case of a woman in whom two intrauterine contraceptive devices were found to have perforated (torn) the uterine wall and migrated to the abdominal cavity.This woman, 37 years old at the time of her presentation to doctors with “chronic lower back pain” had two years previously begun using a Mirena® IUD. After two months’ use, a follow-up visit with her doctor revealed an empty uterus, and it was concluded that the IUD had been expelled without the patient noticing. So, another Mirena® IUD was put in place. Shortly after the insertion of that IUD, however, a follow-up visit could not locate the device, and unsure of whether the IUD had migrated or been expelled, no further action was taken.When she came to her doctor with this lower back pain, an X-ray ordered by her chiropractor showed that the two IUDs had not been expelled, but rather had torn the uterine wall and entered the abdominal cavity.
After the adhesions between the IUDs and the omental fat and lateral abdominal wall were severed, the devices could be removed through laparoscopy, a surgical procedure aided by tiny cameras mounted on surgical equipment. Thankfully, the surgery went well for this woman and she made a full recovery without complication.By the time this paper was published, there were already 165 cases of migrated IUDs in the medical literature. “Over one half (86) of those were found in the [abdominal] cavity; another 54 had penetrated the intestinal wall, 23 were inside the urinary bladder, one in the adnexum, and one in the iliac vein.”
Unfortunately, many women may face the risk of IUD migration unnecessarily and unknowingly, due to the fact that Bayer Pharmaceuticals, the manufacturer of the Mirena® IUD, has repeatedly failed to adequately warn users of risks associated with its product.Complications associated with IUD migration include, but may not be limited to, “peritonitis, abscess/ granuloma formation, bowel obstruction, chronic pain, and infertility.”
Three Cases of Mirena Migration Reported Together
March 13th, 2013
An article published by Mohammad S. Mahmoud and Zaher O. Merhi of the Department of Obstetrics and Gynecology at the University of Illinois and the Albert Einstein College of Medicine, respectively, titled “Computed tomography-assisted laparoscopic removal of intraabdominally migrated levonorgestrel-releasing intrauterine systems” describes how the use of computed tomography (CT) scans can be useful in the removal of intrauterine contraceptive devices (IUDs) that have perforated the uterus and migrated into the abdominal cavity.This article presents three cases in which a Mirena IUD had migrated outside the uterus into the abdomen and required computed tomography to locate the device precisely before laparoscopic removal of the Mirena system.
Case 1: The first case presented in this article is that of a 25-year-old woman. This woman had used a Mirena® IUD for four months prior to coming to her doctor for an annual checkup, at which time she complained of “occasional mild premenstrual lower left quadrant pain ever since the insertion”. Physical examination revealed that the removal strings of her IUD were not visible in the cervical canal, so a pelvic ultrasound was performed, which confirmed that the IUD was no longer present in the patient’s uterus.To determine whether the IUD had been expelled or if it had migrated to another location in the abdomen, a computed tomography scan was performed. The IUD was found not to have been expelled, but had migrated to “the left paracolic gutter, closely adjacent to the lateral wall of the distal descending colon at the junction of the descending rectosigmoid colon”. Laparoscopy revealed that the IUD had become adherent to the “omental fat on the left side of her abdomen”, and once those adhesions were severed, the IUD was able to be removed.Thankfully, the patient “was discharged home the same day of the procedure” and “postoperative follow up care was uneventful”.
Case 2: This case was that of an 18-year-old woman who had used a Mirena® for 16 months before presenting to doctors with “new onset daily vaginal spotting but no abdominal pain”. As was the case for the previously-discussed patient, physical examination could not locate the IUD removal strings in the cervical canal, so pelvic ultrasound was performed. When ultrasound confirmed that the IUD was not present in the uterus, computed tomography was performed and located the IUD “in the right hemi-pelvis adherent to the uterine wall and just [in front of] the right ovary.”
Laparoscopy revealed the IUD to have adhered to the back of the uterus, and once the adhesions were severed, the device was easily removed without complication whatsoever.
Case 3: In this case, a 34-year-old woman presented to doctors with “mild dull right lower quadrant pain”, three months after the insertion of a Mirena® IUD. When the removal strings of her IUD were unable to be found and subsequent pelvic ultrasound revealed the IUD no longer present in the uterus, it was thought that the IUD had been expelled without the patient’s knowledge. This diagnosis was altered, however, once computed tomography revealed the IUD embedded in fat, just below the coecum (part of the large intestine).
When laparoscopy was performed, the precise nature of the IUDs adherence to the omental fat could be determined and eliminated. Once this was performed, the IUD was removed safely and the woman was discharged home from the hospital. Like the other two patients described in this article, she recovered well and without complication.
Mirena IUD Migrates to Abdomen
March 13th, 2013
The article, aptly titled “Incidental finding of an intrauterine device in the sigmoid colon,” details the case of a 53-year-old woman who had used her IUD for nine years before it was discovered outside of her uterus. For eight years prior to the discovery of her migrated IUD, the woman discussed here had suffered from cancer that had spread from her tongue to many other places in her body, and when doctors attempted to determine if cancer had spread to her abdomen using a CT scan, her doctors discovered an intrauterine contraceptive device “in the sigmoid colon lumen”.
Amazingly, the woman had not experienced any abnormal abdominal pain or diarrhea, symptoms commonly associated with uterine perforation and IUD migration to the sigmoid colon or lower abdomen. Because doctors believed that the IUD was not likely to cause further damage to the woman nor was it likely to further migrate, and because of the woman’s condition, it was decided that the IUD be left in place and closely monitored instead of being surgically removed.
Four months after the discovery of the migrated IUD, the patient died from lung cancer, and fortunately, “during that period of time, the device never caused any symptoms.” Though the course of this patient’s health was not altered by the presence of her migrated IUD, many times IUD migration can result in a number of health complications resulting from the IUDs tendency to adhere to internal organs.
Two Mirena IUDs Migrate in Healthy Woman
March 12th, 2013
In 2008, two Israeli doctors, Avi Tsafrir and Vladimir Plotkin described the case of a woman in whom two migrated Mirena® intrauterine contraceptive devices were found, one having been thought expelled years earlier. The article, titled “One intrauterine device lost, two found” was published in Fertility and Sterility. Here is the original Mirena® migration research.
This woman, aged 41 years at the time she came to hospital, had previously delivered two normal, full-term children without complication. Ultrasound taken after her Mirena® IUD was put in place showed the device correctly situated, but six weeks later with the Mirena® removal strings no longer visible, an X-ray revealed the presence of two Mirena® IUDs in the pelvis. Through uterine perforation, these IUDs had torn the uterine wall and entered the woman’s abdominal cavity. “Apparently, the patient had had an IUD inserted 8 years earlier but had asked to have it removed several months later. At that time, the IUD was not found in the uterus, and the clinical diagnosis was spontaneous expulsion. During laparoscopy, [a surgical procedure involving the insertion of a tiny camera aboard surgical equipment] both IUDs were found to be in the pelvis, one covered with adhesions.”
Though the IUDs that had migrated in this woman were able to be removed without complication, we must keep in mind that any surgical procedure carries inherent risk of complication and infection. Thankfully, uterine perforation by an intrauterine device such as Mirena® is rare.
However, many women around the world may face this risk unknowingly, due to the fact that Bayer Pharmaceuticals (the manufacturer of Mirena®, what is now the world’s most popular IUD) has time and again failed to adequately disclose the risk for perforation and migration to its users.
Mirena Device Migrates to Abdomen, Punctures Colon
March 12th, 2013
An article published in a 2005 edition of The Journal of Minimally Invasive Gynecology details the case of a woman in whom an intrauterine contraceptive device (IUD) completely perforated the uterine wall, entered the abdominal cavity, and punctured the wall of the sigmoid colon.This woman, aged 27-years, had used an intrauterine contraceptive since the birth of her last child. “Subsequently, she conceived; the IUD string was not visible. The pregnancy progressed normally, and she delivered a healthy baby. Ultrasound examination in the postpartum period revealed that the IUD was in an extrauterine location.”
Using a laparoscope, a tiny camera fixated on the end of surgical equipment, “the IUD was found attached to the uterus and the sigmoid colon … Sharp dissection was performed until the IUD was separated from the uterine wall … [and further] dissection freed the IUD completely.”Upon “careful examination,” surgeons found that the IUD “had entered the serosa and muscularis layers of the intestine.” Thankfully, this woman’s surgery went well and she recovered without complication.
Mirena IUD Migrates to Abdomen
March 12th, 2013
In 2009, medical researchers Swati Deshmukh et al. reported on the case of a 23-year-old woman in whom her intrauterine contraceptive device (IUD) perforated (tore) the uterine wall and migrated into her abdomen.Beginning the article, the authors cite that “Uterine perforation is an uncommon complication of intrauterine devices (IUDs). Perforating IUDs can migrate to various locations but paradoxically are rarely found in ovaries or broad ligament.” Though rare, other medical researchers write that uterine perforation may result in life-threatening complications.
This 23-year-old woman had only used her IUD for one week before she came to the emergency room “with worsening right lower quadrant pain radiating to her back and nausea associated with two episodes of [vomiting].” We must note that many IUD migrations take place soon after insertion and that the patient discussed here “experienced pain on insertion.” “On pelvic exam, no IUD [removal] strings were visualized.”Ultrasound taken while the woman was in the hospital quickly revealed that her IUD had perforated her uterine wall and migrated to her right adnexa, a location in the lower abdomen. Using laparoscopy, a surgical procedure involving the insertion of a tiny camera mounted on surgical equipment inserted into the body, the IUD was easily removed, and fortunately, the woman was able to recover without complication.
The relatively easy removal of this woman’s IUD likely is due to several factors. First, as is not always the case, the woman’s migrated IUD was not found to have adhered to any other internal organs. This is likely due to the fact that the detection of the device’s migration was early – only one week after insertion. Because the migration of IUDs in many women is asymptomatic for some time, IUDs may remain in the abdomen for years, allowing them to adhere to or perforate other internal organs.
Mirena Migration Requires Surgery to Correct
March 11th, 2013
A recent article by Dr. George A. Vilos et al. published in The Journal of Minimally Invasive Gynecology titled “Algorithm for Nonvisible Strings of Levonorgestrel Intrauterine System” reviews the case of a 27-year-old woman in whom a Mirena® IUD perforated (tore) the uterine wall and entered the pelvic cavity.
Though rare, uterine perforation caused by a Mirena® IUD is a serious medical condition. Currently, it is estimated that 2.6 of every 1000 insertions of Mirena® IUDs will result in uterine perforation, and as the Mirena® device was “available in more than 100 countries worldwide,” (as of 2010) research on this topic is very important.
Three months after the IUD was put in place in the woman described by Vilos et al., the Mirena® removal strings were no longer visible, and her gynecologist could not locate the device. X-ray taken at that time, however, was able to reveal that the device was located in the right side of the pelvis. Thankfully, with laparoscopy, the device was “easily retrieved”. (Laparoscopy is a surgical procedure involving the insertion of a tiny camera on the end of surgical equipment for enhanced visualization of the surgery.)While this woman was able to recover well, that is not always the case, and we must remember that any surgical procedure carries inherent risks.
Sadly, due to the fact that Bayer Pharmaceuticals, the manufacturer of the Mirena® IUD, has time and again failed to adequately warn users of the dangers associated with its product, thousands of women around the world unknowingly face these risks.
Migrated Mirena Device Punctures Wall of Colon
March 11th, 2013
Published in 2003, an article by Dr. Mete Güngör et al. describes a case of extrauterine migration of an intrauterine contraceptive device. Migration of an intrauterine contraceptive device is a rare but very serious condition, and almost always requires surgery to correct, depending on the location to which the device has migrated.
In this case, an intrauterine contraceptive device used by a healthy 29-year-old woman was unable to be located by ultrasound when the woman came to her doctor noting that the removal strings of her IUD could not be found. Though ultrasound could not locate the IUD, it did reveal the presence of a 4cm mass in the endometrial cavity, which was suggestive of an ectopic (extrauterine) pregnancy. Ectopic pregnancy occurs when an egg is fertilized outside the womb. This is a life-threatening conditioning for the mother, and the fetus cannot survive.Upon X-ray, the device was revealed to have migrated to the pelvic region, just in front of the embryonic sac. At this time, doctors made an “initial diagnosis of misplaced IUD alone with ectopic gestation” and planned a laparoscopy to remove the device. (Laparoscopy is a surgical procedure using a tiny camera inserted into the body through a small hole.) When the laparoscopy was performed, the IUD was found to be densely adhered to the “rectosigmoid, omentum, and part of the right fallopian tube, making it difficult to visualize the IUD.”
Once the adhesions were cut, the device could be better seen, and it was discovered that the IUD had punctured the wall of the colon. The device covered with feces, thorough washing was performed, and eventually was able to be removed; the patient sewn back up, and antibiotics were started. The patient recovered well from the surgery and no complications were encountered.
Though the migration of IUDs is rare (about 2.6 in 1000 IUD insertions results in tearing of the uterus and possible migration), clearly, incidence of migration are very serious medical events. Sadly, thousands of women across the country and around the world may face these potential side-effects without knowing it, for the manufacturer of the world’s most popular IUD – Mirena® by Bayer Pharmaceuticals – has time and again failed to fully disclose all risks associated with its product.
2009 – Mirena Migration Requires Surgery to Correct
March 8th, 2013
In 2009, an article was published by medical researchers B. Thirumagal et al. in International Journal of Gynecology and Obstetrics describing a proposed system of patient management for an asymptomatic woman in whom a Mirena® intrauterine contraceptive device had migrated outside of the uterus after tearing through the uterine wall.This woman was 39 at the time she came to the hospital for “irregular bleeding,” and during her visit, it was found that her intrauterine contraceptive device (IUD) had migrated to the peritoneal cavity (abdomen). This was 19 months after the IUD was put in place and “interestingly she had no abdominal pain.” (Abdominal pain is often what leads women to discover that their IUD has migrated.)
The authors of this article note that about 2.6 of every 1000 IUD insertions will result in uterine perforation, and while occasionally a doctor may chose to leave a translocated IUD in place if it is believed unlikely the device will further migrate, these authors adhere to the norm and recommend that all translocated intrauterine contraceptive devices be surgically removed (if no other option is viable).
Due to the fact that IUD migration may be asymptomatic, a relatively longer period of time may elapse before a correct diagnosis is made, increasing the likelihood that a migrated device may become adhered to internal organs – as was the case in the present article – thus “making surgical removal more challenging”.
Though uterine perforation is considered a rare complication of IUD use, such problems nonetheless do occur around the world, and in some cases may be life-threatening.
Mirena Migrates in Healthy Woman
March 8th, 2013
In one 2010 edition of the medical journal Canadian Association of Radiologists Journal, the “Case of the Month” presented was that of a 38-year-old woman, in whom her intrauterine contraceptive device (IUD) perforated the uterine wall and migrated to the descending sigmoid colon.
The authors, Dr. Donald H. Taves et al. describe the case of an otherwise-healthy woman, aged 38 years, who after having used an intrauterine device for some time, experienced ten months of altered bowel habits and “abdominal pain.” Unaware of the cause of her ailment, the woman continued to experience “alternating constipation and diarrhea with bilateral cramping in the lower abdominal quadrants.”After her visit, her doctors noted that “On physical examination, there was mild tenderness over the left lower quadrant.” Several attempts were made to see if there was something blocking the patient’s colon, neither colonoscopy nor air contrast barium enema revealed any abnormalities. One year later, pain persisting, the woman returned to her doctors for more imaging.
At this time, “abdominal computed tomography (CT) and plain-film abdominal [X-rays] were performed,” and finally, the cause of the patient’s problems was discovered. Her intrauterine contraceptive device was shown on X-ray to have torn through the uterine wall, entered the abdominal cavity, and was pressing upon the sigmoid colon.
Here is the X-ray that revealed the position of the IUD. For clarity, I have placed a blue box around the migrated device.
This finding surprised the patient, “because she had believed that the IUD fell out years ago.” A surgical procedure involving the insertion of a small camera into the abdominal cavity revealed that the IUD had become adhered to the colon, and though it was found that the IUD had scarred the wall of the colon, no tearing of the colon was observed.Fortunately, “The operation successfully removed the IUD, and the patient went on to have an uneventful postoperative recovery.”While this woman’s recovery was unencumbered by complications, that is not always the case. The overall risk for complication in laparoscopy, a common procedure used in the removal of migrated intrauterine contraceptive devices, is reported to be between 1 and 5 per cent.
2010 – IUD Migration Documented in 28-year-old Woman
March 8th, 2013
Uterine perforation – the tearing of the uterus, is a rare and dangerous possible complication of intrauterine contraceptive device (IUD) use. Approximately 2.6 of every 1000 IUD insertions results in uterine perforation. Sometimes, when the uterine wall is heavily perforated, an intrauterine contraceptive device may migrate (move) out of the uterus and into the abdominal cavity. This may cause a variety of other problems and almost always requires surgery to remove.In 2010, medical researchers A.W.N. Meshikhes et al. published a report in The Journal of Obstetrics and Gynecology describing a case of such migration in a 28-year-old woman. This woman had used an IUD for about two years before she came to the hospital complaining of pain radiating from her left hypochondrium to her back lasting two months “with no associated relieving or aggravating factors … [and] denied any history of urinary or bowel symptoms.” After about one year using her IUD, she had reported to her doctor that she could no longer see the removal threads and after X-ray of the abdomen at that time could not locate the device, it was concluded that the IUD had been expelled without the patient’s knowledge.
At her next visit to her doctor, when she came complaining of pain radiating from her left hypochondrium to her back, another X-ray was taken. This X-ray revealed that her IUD had not been expelled, but rather had perforated her uterus and was lying in her abdomen, just at the place from which her pain radiated.Using laparoscopy, a surgical procedure involving the insertion of a tiny camera into the body, the precise location the IUD was determined, and it was found that though the device was very close to the colon, it fortunately had not also perforated the colonic wall. Though highly complex, the surgery required to remove her IUD went well, the IUD was removed successfully, and the woman recovered without event.
The authors warn other doctors that patients with a migrated intrauterine contraceptive device may be “asymptomatic for years or may present with pregnancy or lost strings.” Because migrated intrauterine contraceptive devices may go undetected for some time, a greater opportunity for the IUD to become adhered to other internal organs or cause other problems is fostered.
2011 – “The case of the lost Mirena”
March 7th, 2013
Published in a 2011 edition of Journal of Obstetrics and Gynaecology, an article titled “The case of the lost Mirena” by medical researchers Tsimpanakos et al. describes the case of a 42-year-old woman in whom a Mirena® IUD migrated to her right hemipelvis.This woman had used an IUD for one year before she discovered that the Mirena® removal threads were no longer visible. When she came to her doctor after realizing that she could not locate her Mirena® device, neither transvaginal nor transabdominal ultrasound could locate the IUD. Finally, plain film X-ray was used and found that the device had (perforated) torn the uterine wall and was located in the right hemipelvis.
Here, we may see the X-ray showing the location of the Mirena® device. For clarity, I have chosen to place a blue box around the IUD.
Upon laparoscopy, a surgical technique involving the insertion of a small camera into the body, it was found that the IUD had become densely adhered to the right ovary and back wall of the uterus. After surgery to cut the adhesions and remove the Mirena® IUD, the woman recovered well and without complication. Later, a new IUD was put in place.Discussing this case in general, the authors remind the audience that “Uterine perforation is a serious, although rare, complication of IUD insertion” and warn that “Uterine perforation is not always associated with symptoms of abdominal pain or vaginal bleeding and may remain asymptomatic in over a third of cases”.
IUD Migration in 24-year-old Woman
March 7th, 2013
While intrauterine contraceptive devices (IUDs) remain a popular, effective means of long-term hormonal contraception, these devices do not come without significant risk for dangerous side-effects, such as uterine perforation and IUD translocation (migration). Currently, the world’s most popular intrauterine contraceptive device is manufactured by Bayer Pharmaceuticals, Inc. under the brand name Mirena®, a device that has been found to pose serious risks to its users.In 2009, an article titled “Transmigration of an intrauterine device to the colon wall” by Sergio C. Ribeiro et al., published in International Journal of Gynecology and Obstetrics reviews the case of IUD migration in a 24-year-old woman.
One month after this woman’s IUD was put in place, at a check-up, ultrasound confirmed the IUD’s correct placement. But, six months after the IUD was first put in place, the woman missed a menstrual cycle and came back to her doctor. At this time, ultrasound of the uterus revealed that the device was not present in the uterus and that the woman had become pregnant. “Cesarean delivery was subsequently performed … the IUD was not found and it was presumed to have been expelled prior to conception.”About ninety days later, the woman came back to her doctor, complaining of left hip pain. X-ray taken at that time revealed that her IUD had not been expelled, but rather had perforated (torn) her uterus and had migrated into her lower abdomen.
Upon laparoscopy, a surgical procedure involving the insertion of a small camera through a nearby incision, it was found that the IUD had torn into the colon. Because the device was considered by doctors “unlikely” to further migrate, and the woman had been asymptomatic for some time, doctors believed the risks of the invasive surgery required to remove the IUD outweighed the risks of leaving the device in place. Doctors decided at that time “solely to monitor the patient closely.” The final outcome of this patient’s case was not disclosed in the present article.
2010 – Mirena® Migrates to Sigmoid Colon in 22-year-old Woman
March 6th, 2013
Though rare, migration of an intrauterine contraceptive device (IUD) is widely considered the most dangerous complication of IUD use. In light of this and other possible complications, intrauterine contraceptive devices are a very common form of hormonal contraception, and continue to be used around the world. Currently, the most commonly-used IUD is marketed under the brand name Mirena® (by Bayer Pharmaceuticals), and unfortunately, Mirena® IUDs have been found to cause a staggering number of dangerous complications.In 2010, medical researchers J.K. Prabhu et al. of the Department of Obstetrics and Gynecology at the Jawaharlal Institute of Post-graduate Medical Education and Research in India, described a case of IUD migration in a 22-year-old woman.
This woman had used an IUD for three months before she came to her doctor, complaining of “dull aching pain” that had lasted for one week. Upon examination with ultrasound, the IUD was not visible, and the removal strings were unable to be found. X-ray imaging “showed the IUD to be extrauterine” (outside the uterus) “lying transversely” (sideways). Below, we may see the location of the IUD.
Because the IUD had become densely adhered to the woman’s internal organs, the usual procedure for removing translocated IUDs – laparoscopy – was unavailable, and thus laparotomy was performed; a procedure which also makes use of a small camera inserted into the body. The IUD was discovered “penetrating the serosa of the sigmoid colon.” The IUD was removed successfully, the injury to the sigmoid colon was repaired, and fortunately, the woman recovered without further complication.
Migrated Mirena Removed Laparoscopically
March 4th, 2013
In 2008, medical researchers Erik Lajtman et al. published a research study in The Journal of Gynecological Surgery titled “Uterine perforation by the levonorgestrel-releasing intrauterine device: a case report,” that reviews the case of a 33-year-old woman in whom a Mirena® intrauterine device (IUD) perforated (tore) the uterus and migrated to the omentum where it was found to be mildly adhered to the peritoneum, a membrane that surrounds the abdominal cavity.Eighteen months after a transvaginal ultrasound had confirmed the presence of the IUD in the uterus after placement, a routine examination by ultrasound showed that the IUD was no longer in its correct place, and the uterus was found vacant. Radiograph taken at this time revealed that her IUD had migrated outside of the uterus to the omentum and had become adhered to the peritoneum.
Fortunately, her doctors stated “A simple laparoscopic procedure with the removing of IUD was accomplished” and “the patient was discharged 24 h after laparoscopy.”
Migrated Mirena Device Removed Surgically
March 4th, 2013
A report published in a 2011 edition of The American Journal of Obstetrics and Gynecology titled “Endoscopic treatment of a transmigrated intrauterine device to colonic wall: a case report” by Dr. Murat Gonenc et al. reviews the case of a woman, aged 23 years, in whom an intrauterine contraceptive device migrated outside of the uterus to the colonic wall, where the device was removed surgically.
This young woman presented to her doctor for a routine gynecological examination, about one year after her intrauterine contraceptive device was put in place, 6 months after the woman delivered a normal, full-term, healthy child. Normal and transvaginal ultrasounds at this time showed that the IUD was no longer present in the uterus, and the patient stated that she had been experiencing “intermittent abdominal pain and diarrhea.”
After several X-rays were taken, the IUD was found “located in the left side of the pelvis.” Due to the precise location of the IUD as determined by a number of other imaging techniques, the best course of action was determined by her doctors to be removal of the device through the anus. Though the procedure used was complex, no complications were encountered, and the IUD was removed successfully, maintaining good health in the patient.
The authors comment that in certain cases, transanal removal of a migrated IUD is an option preferable to surgery, and may be less likely to produce complications or infection.While this woman recovered well, that is not always the case. Complications found in connection with IUD migration include, among others, “intraabdominal abscess, ureteral obstruction due to fibrosis, colocolic fistulas, volvulus, bowel obstruction, and even death.”
Mirena Migrates in 25-Year-Old Woman
March 4th, 2013
In 2011, medical researchers Dr. Kristin Carmody et al. published a case report titled “Extrauterine Migration of a Mirena® Intrauterine Device: A Case Report” in The Journal of Emergency Medicine, reviewing the case history of a woman in whom her Mirena® intrauterine contraceptive device (IUD) perforated the uterus and translocated (migrated) to the left lower quadrant of her abdomen, where it was removed surgically.This woman, at the time aged 25 years, had used a Mirena® IUD for only one week before she came to the hospital and presented to her physicians with lower abdominal pain, “pelvic cramps, left flank pain,” and stated that she had felt feverish for five days. And though at this time the removal strings of her IUD were no longer visible, the patient denied having witnessed the device’s expulsion from the uterus.Because a transvaginal ultrasound showed an empty uterus, the woman was sent to have an abdominal X-ray, which revealed the presence of the Mirena® IUD, “overlying the left iliac bone”. At this point, the patient’s condition required that her IUD be removed surgically. Fortunately, the patient recovered well after the operation and was released one day after surgery without further complication.
While intrauterine contraceptive devices are widely considered safe, effective means of long-term, reversible hormonal contraception, dangerous side-effects such as Mirena® migration nonetheless do occur and may be life threatening. Often times, people who have experienced Mirena® migration do not exhibit any symptoms whatsoever, and thus the migrated Mirena® device may go undetected for some time – in some cases for years – thus allowing for the possibility for a number of other complications such as adherence of the device to internal organs.
Mirena Class Action Lawsuit Update
March 4th, 2013
I’ve had a few people ask me whether or not they can join the Mirena class action lawsuit. There actually won’t be a Mirena Class Action on behalf of women injured by the Mirena IUD. Instead, there will probably be a Mirena Multi-District Litigation, or MDL. A Mirena MDL will do what most people think a Mirena class action lawsuit will do.
What’s the difference between a Mirena MDL and a Mirena Class Action Lawsuit?
Class action lawsuits are a special type of lawsuit in which a large number of plaintiffs sue one defendant over injuries that are all very similar. Personal injury lawsuits generally aren’t appropriate for class actions because injuries among parties are very different. For example, some women have their uterus punctured by Mirena. Others suffer from an ectopic pregnancy. Still other women end up having a punctured bladder or colon.A class action lawsuit generally ends with a settlement that is evenly divided among everyone. The settlement can only be divided evenly if the injuries are similar enough. Since there are so many different injuries Mirena can cause, a class action lawsuit won’t be appropriate.Instead, several injured women are trying to get a Mirena MDL formed. A Mirena MDL will do a lot of what most folks think a class action will do: It lets injured women work together against the maker of Mirena to prove the product is dangerous or defective. But at the end of a Mirena MDL, each woman’s settlement will be individualized based upon her specific injuries.
Who is eligible to join the Mirena MDL?
As of March of 2013, the Mirena MDL has not yet been approved by the courts. My gut feeling is that it will be, and it will be in the next couple of months. If the Mirena MDL is approved, any woman who suffered injuries because of a Mirena device will probably be eligible to join.
Mirena Migration to Bladder of 32-year-old Woman
February 27th, 2013
“Uterine perforation remains the most serious complication of the intrauterine contraceptive device (IUCD). The incidence ranges from 0.2-9.6 per 1000 insertions (Thomalla, 1986). Since the perforation is often asymptomatic, the real incidence may be higher than 9.6 per 1000. It is estimated that fewer than 2 per cent of perforations affect the bladder (Kiiholma et al., 1989). Other places to which intrauterine devices can migrate are peritoneum, omentum, appendix and colon (Dietrick et al., 1992).”
In 2002, medical researchers Dabbas and Maaita presented the case of a 32-year-old woman in whom an intrauterine contraceptive device migrated out of the uterine cavity by tearing through the upper uterine wall. Upon leaving the uterine cavity, one arm of the t-shaped device tore into the bladder, causing the formation of a bladder stone, and the other arm was found in the pelvic cavity. Upon laparoscopy, the removal threads of the IUD were found to be adhered to the omentum and the bowels. Thankfully, the surgery required to remove the device did not result in further complications and the woman recovered well.
The authors warn that “In spite of its rare occurrence, the possibility of bladder perforation must always be kept in mind when IUCD users show persistent urinary symptoms.”
Currently, the world’s most-used intrauterine contraceptive device is manufactured by Bayer Pharmaceuticals under the brand name Mirena®. Though these devices are considered an effective means of contraception, they do not come without significant risks of adverse health events.
Mirena® Migration Results in Bladder Stone
February 27th, 2013
Medical researchers Z.A. Khan et al. (2006) report the case of a 28-year-old woman in who a Mirena® intrauterine contraceptive device (IUD) perforated the uterine wall completely, entered the abdominal cavity, and upon breaching the bladder wall caused formation of a bladder stone.
Six weeks after a normal, full-term vaginal delivery, a Mirena® IUD was placed in the patient’s uterus without event. One year later, the woman came to her doctor with discomfort in her bladder, and a urinary tract infection was confirmed. At this time, the patient was due for an abdominal X-ray, but for unexplained reasons did not attend. Her pelvic ultrasound showed no abnormalities and she was treated for urinary tract obstruction.
Two months later, her bladder symptoms having returned, the patient requested that her intrauterine contraceptive device be removed, but the device could not be located. Upon insertion of a small camera, the Mirena® device was found to have perforated the uterine wall, and upon entering the abdominal cavity having torn the wall of the bladder. Surgery was not required for the removal of the device, for it was pulled back through the hole it tore in the uterine wall, thus avoiding further injury to the patient.
Soon after the successful removal of her Mirena® IUD, symptoms resolved.
The Mirena® IUD is generally considered an effective means of reversible, long-term contraception. When the device is in its proper place, its daily release of 20mg of levonorgestrel into the uterus stops a woman’s eggs from being fertilized. However, many cases of perforation (tearing) of the uterine wall have been reported with Mirena®. In some cases, such as the one reported here by Khan et al. (2006), complete uterine perforation and subsequent translocation of a Mirena® device caused other medical problems, such as the rupturing of another organ and the formation of a bladder stone. Other cases have determined that a Mirena® device may puncture the colon and appendix upon migration.
Redacted Documents State that Bayer Does Not Believe Mirena Can Migrate After Insertion
February 27th, 2013
While researching a potential Mirena lawsuit, I came across an interesting document filed in a Mirena lawsuit in South Carolina. In that case, one of the issues is whether a Mirena device can migrate after it has been implanted. The current medical literature makes it pretty clear that IUD’s sometimes migrate to other parts of the body after being implanted.
But a redacted document discusses the deposition of Jo-Anne Ruane in a Mirena lawsuit. Bayer offered Ruane as the Associate Director of Global Regulatory Affairs and she apparently testified about the ability for Mirena to migrate after it has been implanted. I say apparently because all of Ruane’s testimony was redacted. We’re instead left only with the Mirena lawyer’s characterization of Ruane’s testimony.
Quotes are used to indicate that Ruane’s testimony was that Bayer does not believe it is “biologically plausible” for Mirena to migrate. It is also stated that Bayer “had no idea that Mirena could spontaneously migrate and perforate the uterine wall.” There is also the statement that “Bayer adamantly denies perforation unrelated to perforation can occur.” The second instance of perforation should be “insertion” as the statement is made in the context that Bayer believes only insertion can cause perforation.The document also states that since “no precaution or warning about spontaneous migration has ever been in the Mirena label, it was not possible for [Bayer] to have warned [doctors] about this event.”
This is critical because the key factor in any pharmaceutical lawsuit will be proving that the manufacturer failed to adequately warn of the risks of whichever injury the plaintiff suffered.There is also an implication that the warning label for Mirena does not accurately report the number of uterine perforations that occur with the device. Apparently, the European Journal of Contraception and Reproductive Health Care published an estimate of 9.6 per 1000 insertions, which is much higher than existing estimates of 2.6 per 1000 insertions.
Risk for Mirena IUD Perforation Explored
February 26th, 2013
An article published in a 2006 edition of the medical journal Contraception by K. Van Houdenhoven et al. reviews the risk for uterine perforation caused by levonorgestrel-releasing intrauterine contraceptive devices, such as Mirena®, manufactured by Bayer Pharmaceuticals. Uterine perforation occurs when an intrauterine contraceptive device (IUD) tears the uterine wall, either partially or completely, and may enter the abdominal cavity or other areas of the body. Perforation of the uterus is a serious, possibly life-threatening complication of intrauterine contraceptive device (IUD) use.This study, titled “Uterine perforation in women using a levonorgestrel-releasing intrauterine system,” used data from gynecologists in hospitals in the Netherlands between 1999 and 2002, and aimed to determine the overall risk of uterine perforation caused by use of an IUD. Overall, it was found that about 2.6 in every 1000 insertions of an IUD will result in perforation of the uterus.
Some researchers believe that perforation is more common in breastfeeding women, though others disagree.
2009 – Mirena® IUD Migrated, Found Embedded in Omentum
February 26th, 2013
In 2009, medical researchers Asimakis Pappas et al. published an article titled “A levonorgestrel-releasing intrauterine system embedded in the omentum in a woman with abdominal pain: a case report” in Journal of Medical Case Reports, outlining the case of a woman whose intrauterine contraceptive device (IUD) had migrated outside of the uterus into the abdominal cavity.The Mirena® intrauterine contraceptive device is a small, t-shaped plastic device that upon being placed in the uterus may prevent pregnancy for up to five years by releasing a small amount of the progestin levonorgestrel into the uterus each day. At the time the Pappas et al. piece was published, Mirena® accounted for 3% of all contraceptive methods used in England.
Though Mirena® is generally considered an effective means of contraception, it has been associated with several significant adverse health effects including pelvic inflammatory disease, ectopic pregnancy, and uterine perforation (tearing of the uterine wall). Among all intrauterine devices, the risk of uterine perforation remains low – about 0.2-0.3 per 1000 insertions, though Mirena® itself is found to perforate the uterus about three times more frequently than other IUDs – about 0.9 in 1000 insertions.
The case described by Pappas et al. (2009) is that of a 33-year-old woman, in whom a Mirena® IUD was placed four years prior to hospital admission, at which time she complained of severe abdominal pain and “a problematic bleeding pattern.” X-ray at that time showed that the IUD was no longer in place in the uterus, but had torn through the uterine wall and was embedded in the omentum, near the bladder.
Soon after the discovery of the translocated Mirena® IUD, a minimally-invasive surgical procedure known as laparoscopy was performed, and the IUD was removed without complication.Though this woman made a healthy recovery, the authors of this paper warn that “Uterine perforation is a serious, albeit rare, complication of intrauterine contraceptive use.” Pappas et al. also recommend that if the removal strings of a Mirena® IUD are no longer visible, it is not prudent to assume that the device has been expelled, and an abdominal X-ray to locate the IUD ought to be performed.
The authors conclude with the following statement:“This case report demonstrates the need for regular IUS thread checks and that following an ultrasound report showing an empty uterus in a symptomatic patient, an abdominal X-ray should be performed to identify whether or not the IUS is inside the peritoneal cavity. We advocate that following basic rules after IUS insertion, such as hysteroscopic insertion post ablation, annual check-up of IUS position, X-ray for a patient complaining of abdominal pain will prevent complications or assist in their early diagnosis.”
Mirena Migration and Ectopic Pregnancy: Case Report
February 25th, 2013
A letter to the editor of South African Medical Journal titled “Mirena and ectopic pregnancy – a diagnostic challenge” by Martin Puzey, published in March of 2006, describes a case of Mirena® migration, a popular intrauterine contraceptive device (IUD) with ectopic pregnancy.Ectopic pregnancy is a pregnancy that was conceived outside the womb, usually in one of the fallopian tubes. This can be a life-threatening condition for the mother, and cannot be survived by the fetus.
It has recently been established that Mirena® use dramatically raises the risk for ectopic pregnancy in women using the contraceptive device, but another, often more serious complication of Mirena® use is migration. Migration of an IUD is when the IUD moves from its original position. The IUD may tear through the uterine wall (uterine perforation) either partially or completely. In cases of complete uterine perforation, the IUD may travel throughout the abdominal cavity, possibly causing a myriad of adverse health effects.In his letter, Martin Puzey describes the case of a woman, aged 27 years, in whom a Mirena® IUD migrated to the top of the uterus, had become embedded in the fundus of the uterus (the upper wall of the uterus), and in whom an ectopic pregnancy was discovered in the right fallopian tube.
Because the ectopic pregnancy could be deadly to the woman, it was terminated, and laparoscopic surgery was used to remove the Mirena® IUD from the upper uterine wall.
Fortunately, the patient made an uneventful recovery and was soon discharged in good health. However, this is not always the case. Mirena® IUD migration and ectopic pregnancy constitute serious health risks that must not be overlooked.
Mirena IUD Migration and Ensuing Complications
February 25th, 2013
An article published in a 1994 edition of the Italian medical journal Minerva Ginecologica by P.R. Broso and G. Buffetti titled “The IUD and uterine perforation” reviews the risk for and resulting health problems of uterine perforation caused by intrauterine contraceptive devices (IUDs). Uterine perforation is the tearing of the uterine wall. The perforation may be partial or complete, and depending on the severity of the perforation, and whether or not the IUD vacates the uterus upon complete perforation, a range of adverse health effects may ensue.Broso and Buffetti state that because IUD use is so common (at that time IUDs were used by 15% of Italian women at childbearing age), the “potentially fatal” complication of uterine perforation must be thoroughly researched.The authors of this article also write that sometimes, a woman suffering from uterine perforation by an IUD may experience pain or other symptoms that she may indicate to her physician, but many times women with uterine perforation caused by IUD use are asymptomatic.
Further, Broso and Buffetti warn that “A patient who has sustained a perforation is not protected against pregnancy,” and write that as a result of IUD-induced uterine perforation, “serious consequences have been described, such as severe damage to the viscera (i.e. bowel, kidney) and/or peritonitis.”
Though this article was published nearly 20 years ago, the problem of uterine perforation caused by intrauterine contraceptive devices continues to affect thousands of women every year. It has recently been alleged that Bayer Pharmaceuticals, the manufacturer of Mirena®, currently the most popular IUD knew, or should have known, of these risks long ago but nonetheless failed to warn its users.
Mirena Ectopic Pregnancy
February 25th, 2013
An article published in the October of 2012 edition of the Czech medical journal Ceska Gynekol titled “Intrauterine system (Mirena) and ectopic pregnancy–case report” describes a case of ectopic pregnancy in a woman who was using a Mirena® intrauterine contraceptive device (IUD).
Here is the abstract for that article:“An ectopic pregnancy are [the] most common gynaecological emergenc[y]. The large majority (95%) of ectopic pregnancies occur in Fallopian tube. Although pregnancy is rare in women who use intrauterine system Mirena, women who do become pregnant while using Mirena have a high risk of ectopic pregnancy. These pregnancies can be watchful for any signs of an ectopic pregnancy, such a severe abdominal pain accompanied by unusual vaginal bleeding.”
PubMed Health, a prominent online medical encyclopedia curated by the U.S. National Library of Medicine writes that “An ectopic pregnancy is a pregnancy that occurs outside the womb (uterus). It is a life-threatening condition to the mother. The baby (fetus) cannot survive.”Due to the fact that Bayer Pharmaceuticals, the manufacturer of Mirena®, has time and again failed to warn users of this dangerous side-effect related to Mirena® use, a number of Mirena® lawsuits have been filed seeking compensation for injuries sustained by users through no fault of their own.
Mirena® IUD Migration in 28-year-old Woman
February 25th, 2013
An article published by Kurdoglu et al. in a 2010 edition of Case Reports in Medicine describes the case of intrauterine contraceptive device migration and subsequent pregnancy in healthy 28-year-old woman.
Dubbed a “frequently encountered complication” of Mirena® brand intrauterine contraceptive device (IUD) use, IUD migration is when an IUD tears (perforates) the uterine wall and moves (migrates) to another location in the body. This can cause a variety of problems in women, depending on the location to which the IUD has migrated, and usually requires surgery to correct.In the case presented by Kurdoglu et al., the woman had been using an IUD since her last child was born, and presented with “secondary amenorrhea lasting 5 weeks and lower abdominal pain lasting a year.” MedlinePlus, a medical encyclopedia provided by the U.S. National Library of Medicine and the National Institutes of Health, states that “secondary amenorrhea occurs when a woman who has been having normal menstrual cycles stops getting her period for 6 or more months.”
Routine physical examination of the woman was normal, but upon transvaginal ultrasonography, her IUD was found embedded in her bladder. To be clear, this means that the IUD had torn the uterine wall, completely left the uterus, and had punctured the lining of the bladder. As the IUD was not present in the uterus, its contraceptive capacity was nullified, and the woman had become pregnant. “[A] five-week gestational sac was determined in the uterine cavity.”
The pregnancy was terminated upon request of the patient, and fairly invasive surgery was performed to cut the IUD from the bladder. Fortunately, two days after surgery, the woman was discharged from the hospital in good health.
Mirena® IUD Risk of Ectopic Pregnancy
February 25th, 2013
Mirena® is an intrauterine contraceptive device manufactured by Bayer Pharmaceuticals that releases a small daily dose of the progestin levonorgestrel into the uterus to prevent pregnancy. Levonorgestrel is also used in a number of oral hormonal contraceptives. While this intrauterine device (IUD) is an effective, reversible means of birth control, it does not come without significant risk of adverse health effects.
In addition to uterine perforation and migration, in which Mirena® tears through the uterine wall and may enter the abdominal cavity, possibly causing a variety of problems, Mirena® use dramatically increases the risk of ectopic pregnancy in its users.
Ectopic pregnancy is a pregnancy in which the conception thereof takes place outside the uterus, often in a fallopian tube. The prominent online medical encyclopedia curated by the United States National Library of Medicine, PubMed Health, states that ectopic pregnancy “is a life-threatening condition to the mother” and warns that “the baby (fetus) cannot survive.”
When the drug and medical device review website DailyMed, published by the National Institutes of Health and the United States National Library of Medicine, reviewed Mirena®, it was warned that “up to half of pregnancies that occur with Mirena in place are ectopic.” (emphasis added)While the overall risk of pregnancy with Mirena® in place remains low, such a high rate of ectopic pregnancy is a risk that must not be overlooked.
Mirena® IUD Migration “Frequent”
February 22nd, 2013
Research published in the March-April 2012 edition of the medical journal Radiographics has determined that “a frequently encountered complication” of intrauterine contraceptive devices (IUDs) such as the popular Mirena® IUD is migration, or “translocation,” of the IUD.This article describing Mirena® migration, published by Dr. H.E. Boortz et al. states that types of migration (movement from original placement) of an IUD can vary from expulsion (the IUD is expelled out of the uterus), to “displacement into the endometrial canal,” to “uterine perforation,” in which case the IUD tears the uterine wall and may enter the abdominal cavity, possibly causing a myriad of problems.
The course for treatment of IUD migration depends on the type of migration that has taken place. If the IUD was expelled, the efficacy of the contraceptive is nullified, and a simple replacement could suffice to regain contraceptive efficacy. If the IUD becomes embedded into the uterine wall (myometrium), the condition “can usually be managed in the outpatient clinical setting but occasionally requires hysteroscopic removal.” Hysteroscopic removal involves the non-surgical insertion through the cervix of a small light and lens (either digital or analog) to locate and analyze the position of the embedded IUD, followed by the insertion of surgical tools used to remove the device once it is located. This may be done in a number of settings and may require either local or general anesthetic.“Complete uterine perforation, in which the IUD is partially or completely within the peritoneal cavity” (abdominal cavity) “requires surgical management, and timely and direct communication with the clinician is essential in such cases.”
The authors warn that in cases of complete uterine perforation, “Careful evaluation for intraabdominal complications is also important, since they may warrant urgent or emergent surgical intervention.”
Because Bayer Pharmaceuticals, the manufacturer of the most common IUD, marketed under the brand name Mirena®, has failed to warn users of these potential risks, they may be held liable for injury caused to users.
1981 – Diagnosis of IUD Migration
February 22nd, 2013
Since 1990, Bayer Pharmaceuticals has been marketing an intrauterine device (IUD) under the brand name Mirena®, an IUD which releases a controlled amount of the progestin levonorgestrel into the uterus daily. While this is an effective means of contraception – about as effective as oral contraceptives, intrauterine devices come with the risk for serious adverse side effects.In 1981, nine years prior to the release of Mirena®, D. Zakin et al. published a report in the medical journal Obstetrical and Gynecological Survey reviewing diagnostic methods for uterine perforation caused by an IUD, what is not considered “a frequently encountered complication” of IUD use. Uterine perforation is the complete or partial tearing of the uterine wall by an intrauterine device. Risk for a number of complications is dramatically increased if the complete uterine perforation is experienced, as in that case the IUD may move without restriction though the abdominal cavity, free to damage or adhere to a number of vital internal organs. Both complete and partial uterine perforation are serious ailments – partial perforation usually requires surgery and complete perforation always requires surgery to correct the ailment.Zakin et al. discuss six different methods for diagnosing uterine perforation and locating the migrated IUD, each method having its own benefits and downfalls.The first method discussed was radiography, or “plain film.” This method is generally avoided by physicians because not all IUDs will appear on plain film. Next, Zakin et al. discuss hysterography. This method is said to allow “the best diagnostic assessment since it allows the visualization of the entire uterine cavity so that the position of the IUD is immediately evident in cases of embedding and of perforation.” Additionally, the imaging technique known as “pelvic pneumography” allows for the differentialtion between “intraperitoneal or extraperitoneal locations of perforated IUDs.”
Concerning the remaining methods, the comments made by Zakin et al. are fairly straightforward: “Ultrasonography simply determines the presence or absence of an IUD, but has the advantage of accurately demonstrating a concomitant pregnancy; the sonogram is not reliable if the IUD is surrounded by omentum or by loops of bowel; ultrasonography can be advantageously coupled with hysterography.
Laparoscopy is still the method most used to diagnose uterine IUD perforation; when removal of the device is advisable laparotomy is usually carried out concomitantly; successful laparoscopy requires a skilled and experienced operator.
Hysteroscopy is a new and extremely valuable technique which should not be chosen as a primary procedure because it carries a risk of complications.”Concluding, the Zakin et al. paper states, “Removal of an IUD, whether through the vagina or through hysteroscopic, laparoscopic, laparotomy, or hysterotomy procedures, is never easy. Emergency hysterectomy is done under certain circumstances, such as hemorrhage, while elective hysterectomy requires the presence of additional factors, such as a fibroid uterus.”
2002 – Mirena Migrates to Upper Abdomen, Causes Ectopic Pregnancy
February 21st, 2013
Intrauterine contraceptive devices (IUDs) are a very common, effective means of hormonal contraceptives. Some reports cite that an IUD made by Bayer Pharmaceuticals marketed under the brand name Mirena® is the most commonly-used IUD in the world, “with prevalence rates ranging among countries from 2% to 80% of contraceptive users.”
Though Mirena® is an effective contraceptive, it comes with risk of significant adverse health effects. Recently, it has been found that Mirena® IUDs may move (“migrate”) outside the uterus by tearing a hole in the uterine wall (“perforation”) thereby entering the abdominal cavity where it is free to come in contact with other organs, possibly causing a myriad of complications and almost always requiring surgery to remove.Another complication associated with Mirena® use is an increased risk of ectopic pregnancy. Ectopic pregnancy occurs when conception has taken place outside the uterus, usually in a fallopian tube. PubMed Health, a prominent online medical encyclopedia curated by the U.S. National Library of Medicine states that ectopic pregnancy “is a life-threatening condition to the mother,” and writes that in ectopic pregnancy, “The baby (fetus) cannot survive.”
Research by the National Institutes of Health concerning the safety of Mirena® has found that while the overall risk of pregnancy while using Mirena® is low, “up to half of pregnancies with Mirena® in place are ectopic.” (emphasis added)Recently, a study published by Kwong et al. (2002) in the Journal of Family Planning and Reproductive Health Care titled “Ectopic pregnancy with a translocated Mirena® intrauterine System” illustrates the case of a 39-year-old woman in whom a Mirena® IUD migrated through the abdomen to the left hypochondrium (beneath the ribs on the left side) the ribs, and an ectopic pregnancy occurred.
After two years’ implantation of her Mirena® device, the woman came to her doctor, citing five days of “per vaginum blood spotting” and pain from the upper-left portion of the hip bone. It was also noted at this time that her last menstrual period was seven weeks prior to the admission date. While under her doctor’s care, hormone tests were taken, and it was found that levels of Beta-hCG were at 1815 IU/L, suggestive of a pregnancy between its sixth and eighth week of gestation.
Ultrasound of the uterus, however, showed an empty uterus, void of her Mirena® device, and without a fetus. Thus, X-ray was used, and the IUD was located “in the left hypochondrium.” “Clinical findings and investigations were suggestive of an ectopic pregnancy and a laparoscopy was performed.” Laparoscopy is a surgical procedure in which a small incision in the abdomen is made, and through which a small camera is inserted. “At laparoscopy, there was blood in the pelvis and a mass, about 3 cm in diameter, was found in the ampulla of the left fallopian tube suggestive of an ectopic pregnancy.”
The Mirena® was removed, and fortunately, the woman made an uneventful recovery, and was released two days after the operation.
Thankfully, this woman survived the ectopic pregnancy and did not experience any dangerous complications from her surgery. This, however, is not always the case. Moreover, it is likely that the woman discussed in the Kwong et al. (2002) article was unaware of the possibility of Mirena® migration and the risk for ectopic pregnancy before use of the IUD: it is currently alleged that Bayer Pharmaceuticals, the manufacturer of Mirena® concealed these risks from users, and misled users about the benefits of the device.
Uterine Perforation, Migration Caused by Mirena IUDs
February 21st, 2013
It has recently been found that commonly-used intrauterine contraceptive devices (IUDs) such as Mirena®, a device manufactured by Bayer Pharmaceuticals, may tear through the uterine wall and migrate to other locations in the abdomen after placement. This almost always requires surgery, and may cause many complications, especially in cases in which the IUD adheres to another internal organ.A study published by Dr. Eric M. Heinburg et al. (2008) describes three cases of the migration of intrauterine devices in women. Sadly, it is likely that many of the women who have experienced uterine perforation (tearing) and IUD migration were unaware of these potential risks, and the manufacturer of these IUDs is alleged to have concealed information regarding these risks from users and physicians.
Case One: A 31-year-old woman came to her doctor for a routine postpartum evaluation seven weeks after bearing twins, at which time a Mirena® IUD was put in place without complication. When the woman returned one year later because the strings of the Mirena® device were no longer visible, a “pelvic ultrasonography was promptly obtained and showed a normal, empty uterus with no abnormality. A pelvic x-ray was also obtained and interpreted as normal by the staff radiologist.”
Because it is common that Mirena® IUDs are expelled, and the device was not seen using these imaging techniques, the woman was told her IUD had been expelled. “Later that year, x-rays of the lumbar spine revealed the IUD within the pelvis.” After two surgical procedures, the IUD was located and removed, and the woman recovered without adverse event.
Case Two: A 28-year-old woman had a Mirena® IUD device implanted eight weeks following a cesarean delivery, and “No complication or difficulty was encountered upon placement of the device.” About one year after the placement of her Mirena® IUD, this woman became pregnant and the fetus was spontaneously aborted with the IUD in place. Soon after this, the Mirena® IUD was found to be protruding through the uterine wall. Several attempts to remove the device without surgery were unsuccessful. Successive imaging techniques illustrated the exact location of the IUD embedded in the uterine wall, and a surgery begun by a 1cm incision was successful in removing the Mirena® IUD. Thankfully, the woman recovered well and was released on “the day of her surgery.”
Case Three: This third case was that of a 27-year-old woman using “a Paraguard IUD placed without difficulty 6 weeks after an uncomplicated vaginal delivery.”
Nonetheless, about ninety days after the placement of her IUD, the woman was found to be pregnant. As doctors believed her IUD had been expelled, the normal OBGYN care followed, and after a normal pregnancy, she bore another child.“Six years later, x-rays of her hips incidentally revealed a foreign body suggestive of an ectopic IUD in the left aspect of the pelvis.” After thorough imaging techniques were used, “The IUD was found adhered to the left ovarian fossa,” a circumstance requiring surgery to remove the device. Fortunately, the surgical procedure went well and the patient “was discharged home on the afternoon of her surgery.”
Discussing these three cases more broadly, Heinberg et al. write that “Uterine perforation is the most serious complication associated with use of an intrauterine contraceptive device,” a problem that occurs about 1.2 times per 1000 insertions. While many cases of IUD migration are benign, intestinal complications do occur, which may cause a number of other problems.
Because the manufacturer of Mirena® IUDs, the most commonly used intrauterine contraceptive device, did not adequately warn users of these risks, Bayer Pharmaceuticals may be held liable for injury caused by its products.
Mirena Migration Requires Surgery to Correct
February 21st, 2013
It has recently been found that an intrauterine contraceptive device (IUD) marketed under the brand name Mirena® may move (migrate) from its original location, possibly causing a variety of problems and requiring surgery to remove the IUD.An article published in a 2011 edition of the Journal of the Society of Laproendoscopic Surgeons by Dr. Mark Erian et al., reviews two cases in which a Mirena® IUD migrated outside of the uterus. In one woman, the IUD migrated to “[the back surface of the abdomen] just [in front of] the cecum,” a sac marking the beginning of the large intestine. In the second case, the Mirena® IUD migrated through the abdominal cavity, “close to the left leaf of the diagram.”
When these Mirena® IUDs migrate, the problems that ensue depend on the location to which the IUD has migrated, what, if any, damage was caused as the IUD moved, and finally, on the course required to remove the IUD. If the surgery required to remove the device is invasive, the chance for infection and other issues is raised dramatically.For these two women, thankfully, only a process called laparoscopic retrieval was required. Laparoscopic retrieval is a surgical procedure in which a small incision is made in the abdomen and a laparoscope, a small camera, is inserted. This allows a surgeon to see inside a body and perform surgery without requiring a large incision, allowing less chance for infection and a shorter recovery time.In the first woman described by Erian et al., aged 44 years, a Mirena® IUD had been implanted for 15 months without problem, until an ultrasound scan of the uterus during a routine cervical smear “confirmed that the device was not in the uterus.” To locate the missing IUD, a “computerized tomography scan,” or three-dimensional X-ray, was used, confirming that the IUD was on the right side of the rear of the abdominal cavity, just in front of the cecum, a sac that constitutes the beginning of the large intestine.The laparoscope camera also revealed that the device had become adhered to the cecum and a fatty layer called the omentum, requiring laparoscopic adhesiolysis to sever the IUD from the woman’s organs. Fortunately, this procedure was uneventful, the device was removed successfully, and the woman was discharged healthy after the procedure.
The second case described in the Erian et al. piece entails the migration of a Mirena® IUD in a 19-year-old woman. This woman had been using the Mirena® IUD since the time a pregnancy was voluntarily terminated, and after 10 days’ insertion, the woman complained of “acute severe pelvic pain.” Ultrasound of the uterus showed that the uterine cavity was empty by that time.“Plain X-ray” revealed that the IUD had migrated through the peritoneal cavity (abdomen) to just below the diaphragm. Again, fortunately, the device was removed from this woman without complication, and she was discharged soon after surgery in good health.
Discussing these two cases broadly, Erian et al. write that Mirena® is a generally effective product in terms of its contraceptive capacity, but note that the device has important side-effects. “Continuing pain and discomfort as well as irregular vaginal bleeding” are written to be common side-effects, and it is also noted that migration of the IUD and perforation (cutting) of the uterus are possible dangerous side effects of which patients should be warned before IUD use.