April 2013

In 2008, Dr. Rebecca U. Margulies et al. published a report in The American Journal of Obstetrics and Gynecology that discussed complications requiring surgery following vaginal mesh kit procedures for prolapse.  Aptly so, the article is titled “Complications requiring reoperation following vaginal mesh kit procedures for prolapse” and that original research showing the danger of transvaginal mesh may be found by following the link above.

Of thirteen women who underwent “surgery for vaginal mesh-related complications,”[1] studied, the Margulies et al. found ten cases of “symptomatic mesh exposures,”[2] one “exposure with pelvic abscess,”[3] and “2 had pain symptoms without mesh exposure.”[4]  Clearly, the most common complication of transvaginal mesh use found here was exposure of the vaginal mesh.  Other medical researchers have found the overall rate for complications related to transvaginal mesh to be between 10 and 20%, obviously an unacceptably-high rate.

Some of the women studied by Margulies et al. (2008) required a second surgery to correct the complications that resulted from the first use of transvaginal mesh.  Due to the fact that a number of transvaginal mesh product manufacturers have failed to disclose the risks associated with the use of their products, thousands of women face these dangerous risks unnecessarily and unknowingly.

As such, a number of transvaginal mesh lawsuits are currently being filed and many transvaginal products have come under review by the United States Food and Drug Administration.  If you used transvaginal mesh and experienced transvaginal mesh erosion or another transvaginal mesh side-effect, please do not hesitate to contact our team of transvaginal mesh lawyers for a free case consultation.

At your convenience, you may reach our offices at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.  We have the experience, resources, and skills to help you every step of the way.


[1] Margulies RU, Lewicky-Gaupp C, Fenner DE, et al. Complications requiring reoperation following vaginal mesh kit procedures for prolapse. Am J Obstet Gynecol 2008;199:678.e1-678.e4

[2] Ibid.

[3] Ibid.

[4] Ibid.

A report by Dr. Gouri B. Diwadkar et al. (2009) published in Obstetrics and Gynecology has found that rates of complication with the use of transvaginal mesh products is unacceptably high, reaching levels of more than 19%.[1]

Retrospectively analyzing previously-published studies of the safety and efficacy of transvaginal mesh that used more than 50 participants between January 1985 and January 2008, the Diwadkar team set out to determine the likelihood of complications resulting from the use of transvaginal mesh.  Of the 3,425 cases the Diwadkar team reviewed, 433[2] patients required surgical “intervention not under general anesthesia,”[3] and 245[4] required “intervention under general anesthesia.”[5]  This creates a total of 608 patients that required surgical intervention to resolve complications of transvaginal mesh use.

Though transvaginal mesh is an effective means of organ reparation, the frequency with which surgical intervention is required is far too high.  Due to the fact that the manufacturers of transvaginal mesh products have failed to disclose the risks associated with the use of their products, coupled with the fact that over 1,000 adverse events related to transvaginal mesh have been reported to the United States Food and Drug Administration, many transvaginal mesh lawsuits are currently being filed.

If you or a loved one has used transvaginal mesh and experienced a complication such as vaginal mesh erosion, please do not hesitate to contact our team of transvaginal mesh lawyers for a free, no-obligation case consultation.

At your convenience, you may reach our offices by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.  If you are unsure whether you may have a case or would simply like more information, give us a call.  We are here to help.


[1] Diwadkar, GB “Complication and Reoperation Rates After Apical Vaginal Prolapse Surgical Repair: A Systematic Review” Obstetrics and Gynecology Vol. 113, No. 2, Part 1. (2009) 367-373

[2] Ibid.

[3] “Clavien-Dindo Classification” SurgicalComplication.info Department of Surgery, University Hospital Zurich, Switzerland © 2008-2009 Available at <http://www.surgicalcomplication.info/index-2.html> Accessed 29 April 2013

[4] Diwadkar, GB “Complication and Reoperation Rates After Apical Vaginal Prolapse Surgical Repair: A Systematic Review” Obstetrics and Gynecology Vol. 113, No. 2, Part 1. (2009) 367-373

[5] “Clavien-Dindo Classification” SurgicalComplication.info Department of Surgery, University Hospital Zurich, Switzerland © 2008-2009 Available at <http://www.surgicalcomplication.info/index-2.html> Accessed 29 April 2013

ABC News recently published a report investigating the ongoing problem of nursing home abuse, revealing that the “elderly [are] abused at 1 in 3 nursing homes“.  Currently, about two million Americans reside in long-term nursing care facilities, thus placing over 600,000 elderly persons at risk for abuse.

“Numerous” cases of “serious, physical, sexual and verbal abuse” have been reported, and problems such as “ntreated bedsores, inadequate medical care, malnutrition, dehydration, preventable accidents, and inadequate sanitation and hygiene” have resulted.

A report by the Special Investigations Division of the House Government Reform Committee found that form 1999 to 2001, over nine thousand such cases were reported from 5,283 American nursing homes, accounting for over 30% of facilities.

“In some reported cases, a member of the nursing home’s staff was accused of committing physical or sexual abuse. In others, staff were cited for failing to protect people from abuse by other residents.

The report documents instances of residents being punched, slapped, choked or kicked by staff members or other residents, causing injuries such as fractured bones or lacerations.

Some of the violations uncovered are particularly disturbing. In one case, according to the report, an attendant walked into a resident’s room, said “I’m tired of your ass,” and hit her in the face, breaking her nose.

In another case, attendants bribed a brain-damaged patient with cigarettes to attack another resident, then watched the two fight. The report also described a case in which a male attendant molested an elderly female resident while bathing her.

Instances of abuse appear to be on the rise. The percentage of nursing homes cited for violations has increased every year since 1996, according to the report.”

Further, elucidating this issue, “Another report prepared by the minority staff of the Special Investigations Division … found more than 70 percent of 59 homes in one Pennsylvania congressional district failed to meet federal health and safety standards during recent state inspections.

Such standards included measures for preventing pressure or bed sores, providing sanitary living conditions, and protecting residents from accidents, that report said.

More than half the homes, it said, had violations that caused actual harm to residents or had the potential to cause death or serious injury.”

While there are both federal regulations for nursing home care and state regulations for nursing home care, delineating specific rights legally guaranteed to nursing home residents, all too often those rights are infringed upon and the elderly are abused.  If you or a loved one has experienced nursing home abuse, please do not hesitate to contact our team of nursing home abuse lawyers for more information or a free case consultation.

At your convenience, you may reach our offices by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.  We have the experience, resources, and skills required to win the justice you deserve.

Nursing Home Abuse and Neglect Overview

Nursing Home abuse and neglect continue to be serious problems affecting some of our nation’s most vulnerable.  About two million Americans are currently receiving long-term care at a nursing home facility, and all too often, the rights of residents are infringed upon by nursing home staff.   Choosing to live at a certain nursing home facility does not constitute a waiver of rights, and the rights of the elderly must be protected.

Federal law defines “abuse” and “neglect” as follows:

  • Abuse: an intentional infliction of injury, unreasonable confinement, intimidation, care/service deprivation or punishment that results in physical harm, pain or mental anguish
  • Neglect: a failure, intentional or not, to provide a person with the care and services necessary to ensure freedom from harm or pain; a failure to react to a potentially dangerous situation resulting in resident harm or anxiety

And, under United States federal law nursing home residents have the following rights:

“Each resident has the right to be free from mistreatment, neglect and misappropriation of property. This includes the facility’s identification of residents whose personal histories render them at risk for abusing other residents, and development of intervention strategies to prevent occurrences, monitoring for changes that would trigger abusive behavior, and reassessment of the interventions on a regular basis.[1]

Under federal nursing home regulations, nursing homes must:

  • Have sufficient nursing staff. (42 CFR §483.30)
  • Conduct initially a comprehensive and accurate assessment of each resident’s functional capacity. (42 CFR §483.20)
  • Develop a comprehensive care plan for each resident. (42 CFR §483.20)
  • Prevent the deterioration of a resident’s ability to bathe, dress, groom, transfer and ambulate, toilet, eat, and to communicate. (42 CFR §483.25)
  • Provide, if a resident is unable to carry out activities of daily living, the necessary services to maintain good nutrition, grooming, and personal oral hygiene. (42 CFR §483.25)
  • Ensure that residents receive proper treatment and assistive devices to maintain vision and hearing abilities. (42 CFR §483.25)
  • Ensure that residents do not develop pressure sores and, if a resident has pressure sores, provide the necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. (42 CFR §483.25)
  • Provide appropriate treatment and services to incontinent residents to restore as much normal bladder functioning as possible. (42 CFR §483.25)
  • Ensure that the resident receives adequate supervision and assistive devices to prevent accidents. (42 CFR §483.25)
  • Maintain acceptable parameters of nutritional status. (42 CFR §483.25)
  • Provide each resident with sufficient fluid intake to maintain proper hydration and health. (42 CFR §483.25)
  • Ensure that residents are free of any significant medication errors. (42 CFR §483.25)
  • Promote each resident’s quality of life. (42 CFR §483.15)
  • Maintain dignity and respect of each resident. (42 CFR §483.15)
  • Ensure that the resident has the right to choose activities, schedules, and health care. (42 CFR §483.40)
  • Provide pharmaceutical services to meet the needs of each resident. (42 CFR §483.60)
  • Be administered in a manner that enables it [the nursing home] to use its resources effectively and efficiently. (42 CFR §483.75)
  • Maintain accurate, complete, and easily accessible clinical records on each resident . (42 CFR §483.75)[2]

State-provided rights of nursing home residents vary by state.  A state-by-state breakdown of nursing home resident rights may be helpful if you believe a loved one is experiencing nursing home abuse or neglect.

As this developing problem continues to unfold, our team of Nursing Home Abuse and Neglect Lawyers will continue to post new information and clarify issues as they become apparent.  If you believe a loved one is suffering from nursing home abuse or nursing home neglect, do not hesitate to contact our offices for more information or a free case consultation.

At your convenience, you may reach our offices by phone at (855) 452 – 5529 or by e-mail at justinian@dangerousdrugs.us.  Call today and see how we can help.

 

Recently, an article published in the British Journal of Obstetrics and Gynecology has shown that while transvaginal mesh products are effective in the treatment of damaged uterine or vaginal walls following pelvic organ prolapse, these products carry a risk of mesh erosion as high as 10%.[1]

Analyzing federal databases that keep medical records from 1950 to 2007, the Feiner et al. (2008) team found that transvaginal mesh is up to 95% effective in the repair of damaged tissues as a result of pelvic organ prolapse but that the complication of vaginal mesh erosion remained between 4.6 and 10.7%.[2]

This research corroborates the findings of many other medical researchers, such as Gopal Badlani (2012) who found that vaginal mesh erosion occurred in 10.3% of cases.  Strengthening his report, Badlani’s data was collected using a study that reviewed over 10,000 patients.

Due to the fact that the manufacturers of transvaginal mesh products have time and again failed to include the findings of recent medical research in the warning labels on their products, a number of transvaginal mesh lawsuits are currently being filed.

As it currently stands, the United States FDA has decided to review the efficacy and safety of these products as more than 1,000 reports of negative side-effects related to transvaginal mesh have been reported.

If you or a loved one used transvaginal mesh and experienced vaginal mesh erosion, you may be eligible to significant financial compensation through a transvaginal mesh lawsuit.  For more information or a free case consultation, you may contact our team of Transvaginal Mesh Lawyers by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

Our Transvaginal Mesh Lawsuit Information page is a great place to start if you have additional questions about Transvaginal Mesh.


[1] Feiner B, Jelovsek J, Maher C. Efficacy and safety of transvaginal mesh kits in the treatment of prolapse of the vaginal apex: a systematic

review. BJOG 2009;116:15–24

[2] Ibid.

A recent article published in a 2011 edition of International Urogynecology Journal titled “Surgical management of mesh-related complications after prior pelvic flood reconstructive surgery with mesh” by Myrthe M. Tijdink et al. reviews possible complications of transvaginal mesh after its use in reconstructive surgery in pelvic organ prolapse or another ailment.

This study retrospectively analyzed mesh-related complications in 73 patients who had undergone “complete or partial mesh excision to treat complications after prior mesh-augmented pelvic flood reconstructive surgery was conducted.”[1]  Mesh excision is a surgical procedure aimed at the removal of the previously-implanted transvaginal mesh, often following persistent negative side-effects such as mesh erosion or transvaginal mesh infection.

The authors of this paper found that though 92% of the time, mesh excision can alleviate persistent symptoms, the “recurrence of pelvic organ prolapse (POP) occurred in 29% of complete and 5% of partial excisions of mesh used in POP surgery.”[2]  Further, it was found that 36% of patients that underwent surgery to remove a suburethral sling experienced new-onset of stress urinary incontinence (SUI).[3]

Concluding, the authors state that “Mesh excision relieves mesh-related complications effectively, although with a substantial risk of serious complications and recurrence of POP or SUI.”[4]

Based on these conclusions, and those of other contemporary researchers that suggest the rate of mesh erosion is 10% for polypropylene mesh and the rate of mesh erosion is 23.8% for silicone mesh, it is advisable that one exercise a high level caution before using transvaginal mesh and that one adhere to the recommendations of medical professionals.

Because the manufacturers of transvaginal mesh products have failed to adequately warn users of transvaginal mesh products of risks associated with those products, a number of transvaginal mesh lawsuits are currently being filed.  If you used transvaginal mesh and experienced transvaginal mesh erosion or transvaginal mesh infection, you may be entitled to significant financial compensation on your behalf through a transvaginal mesh lawsuit.

For a free, no-obligation case consultation, please do not hesitate to contact our team of transvaginal mesh lawyers either by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.  Our Transvaginal Mesh Lawsuit Information page is a great place to start if you have additional questions about Transvaginal Mesh.


[1] Tijdink, MM et al. “Surgical management of mesh-related complications after prior pelvic flood reconstructive surgery with mesh” Int Urogynecol J (2011) 22:1395–1404

[2] Ibid.

[3] Ibid.

[4] Ibid.

An article published in a 2006 edition of the medical journal Scandinavian Journal of Infectious Diseases by Stavros Athanasiou et al titled “Vaginal mesh infection due to Bacteroides melaninogenicus: A case report of another emerging foreign body related infection” details the case of a woman who used transvaginal mesh mesh and subsequently experienced severe infection as a result.[1]

This woman, aged 29 years, required transvaginal mesh in the surgical reconstruction following her “rectocele, cystocele, and uterine prolapse.”[2]  The mesh used in her procedure was polypropylene,[3] a type of transvaginal mesh found to cause vaginal mesh erosion at a rate of over 10%,[4] and ten months after the mesh was put in place, the woman began reporting an “increasing pelvic dragging sensation.”[5]

After review by her physician, it was recommended that she undergo a second surgery to complete an apparently incomplete vaginal reconstructive surgery.

Soon after that operation, symptoms of pelvic organ prolapse subsided and the woman was believed to be recovering well.  Three months after that surgery, “the patient noted an offensive vaginal discharge … and she reported an episode of light vaginal bleeding.  Examination revealed a large mesh erosion of the anterior vaginal wall (2 x 3 cm) … and 2 small erosions of the IVS tape on the posterior vaginal wall. The uterus and the vaginal walls were well supported. A vaginal swab from the area of the exposed mesh was taken and the culture revealed growth of Bacteroides melaninogenicus.”[6]

Once the infection was discovered, the woman was administered antibiotic medications and recovered well.  Twelve months after antibiotics were administered, the woman had not experienced a resurgence of bacterial infection and remains in good health.

While this woman recovered well, vaginal mesh-related infections do not always turn out as such.  And further, thousands of women may face the risk of vaginal mesh-related infection and vaginal mesh erosion unknowingly due to the fact that the manufacturers of many transvaginal mesh products do not provide adequate warnings regarding the safety of their products.

As a result, a number of transvaginal mesh lawsuits are currently being filed.  If you or a loved one used transvaginal mesh and experienced transvaginal mesh erosion or infection, please do not hesitate to contact our team of transvaginal mesh lawyers for a free, no-obligation case consultation.

At your convenience, you may reach our offices by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.  Call today and see how we can help.  Our Transvaginal Mesh Lawsuit Information page is a great place to start if you have additional questions about Transvaginal Mesh.


[1] Athanasiou, S. et al. “Vaginal mesh infection due to Bacteroides melaninogenicus: A case report of another emerging foreign body related infection” Scand J Infect Dis. 2006;38(11-12):1108-10.

[2] Ibid.

[3] Ibid

[4] Badlani, G. et al. “Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review” Indian Journal of Urology 28.2 (April-June 2012): p129

[5] Athanasiou, S. et al. “Vaginal mesh infection due to Bacteroides melaninogenicus: A case report of another emerging foreign body related infection” Scand J Infect Dis. 2006;38(11-12):1108-10.

[6] Ibid.

A recent publication by medical researchers Fred E. Govier et al. in the journal Adult Urology has revealed a shockingly high rate of complication when using transvaginal mesh, a synthetic tissue product used in vaginal reconstructive surgery and other procedures.

The piece, titled “High Complication Rate Identified in Sacrocolpopexy Patients Attributed to Silicone Mesh” analyzed “the data of 45 consecutive patients who underwent abdominal (n=28) or laparoscopic (n=17) sacrocolpopexy.”[1]  Sacrocolpopexy is the technical term for pelvic prolapse repair, which constitutes the repair of the wall separating the pelvic organs from the rest of the body.  Abdominal sacrocolpopexy involves an incision into the abdomen, while laparoscopic sacrocolpopexy is less invasive and involves the insertion of a tiny camera aboard surgical equipment for enhanced visualization of the procedure.

“Of the 45 patients, 21 underwent silicone mesh suspension of the vaginal cuff to the anterior sacrum, with a mean follow-up of 23 months (range 16 to 41). A comparative analysis was performed of 24 patients who underwent the same procedure with polypropylene mesh.”[2]  Of the 21 patients who used silicone mesh as opposed to polypropylene mesh, 5 (23.8%)[3] encountered a “major complication.”[4]

Concluding, Govier et al. state “Silicone-coated polyester mesh has recently been associated with a high rate of vaginal erosion when used as a transvaginal suburethral sling. Our experience specifically with vaginal vault suspension corroborates this. We have abandoned the use of silicone mesh because of the unacceptably high extrusion rate and presently use polypropylene mesh.” (emphasis added)

While this paper only uses a relatively small sample size, it appears to conclude that polypropylene mesh is safe – and it is, when compared to silicone mesh – but other contemporary research has proven that the complication rate for polypropylene mesh is also exceedingly high, reaching levels of over 10%, a number confirmed by studies using thousands of participants.

One such study showing the mesh erosion rate for a variety of transvaginal mesh products is summarized here.

Due to the fact that the manufacturers of transvaginal mesh products have been insufficiently forthcoming about the risks associated with the use of their products, many transvaginal mesh lawsuits are currently being filed.  If you used a transvaginal mesh product and experienced transvaginal mesh erosion or another transvaginal mesh side effect and were unaware of the risks prior to using the product, please do not hesitate to contact our team of transvaginal mesh lawyers as you may be eligible to file a transvaginal mesh lawsuit.

For a free case consultation, you may at your convenience contact our offices by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrug.us.  Our Transvaginal Mesh Lawsuit Information page is a great place to start if you have additional questions about Transvaginal Mesh.


[1] Govier, FE et al. “High Complication Rate Identified in Sacrocolpopexy Patients Attributed to Silicone Mesh” Adult Urology 65:1099-1103, 2005

[2] Ibid.

[3] Ibid.

[4] Ibid.

Published in a 2012 edition of Indian Journal of Urology, an article by Gopal Badlani et al. titled “Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review” reviews the safety and efficacy of transvaginal surgical mesh, a synthetic tissue substance used to repair the vaginal wall in reconstructive surgery.  The specific reconstructive surgery reviewed here is that required in pelvic floor reconstruction.

By searching through the medical research database curated by the United States National Institutes of Health, PubMed, the Badlani et al. team isolated 170 previously-published articles concerning the use of vaginal mesh in pelvic flood reconstruction, and through further review, was able to determine what are the likely complications of vaginal mesh use.

Commenting on their findings, the Badlani et al. (2012) team made the following remarks:

“Synthetic mesh is being increasingly used in the management of pelvic organ prolapse. While the incidence of extrusion and erosion with mid-urethral sling is low, the extrusion rate in prolapse repair is somewhat higher and the use in posterior compartment remains controversial. When used through the abdominal approach the extrusion and erosion rates are lower. The management of mesh complication is an individualized approach. The choice of the technique should be based on the type of mesh complication, location of the extrusion and/or erosion, its magnitude, severity and potential recurrence of pelvic floor defect.”[1]

The types of mesh erosion (the main complication identified by Badlani et al.) were divided into two categories: exposure (the protrusion of the mesh to a visible location), and perforation (the tearing of an organ, cavity wall, or organ lining).  An analysis of the incidence rate reported in over 100 scientific articles, studying a total of 11,785 patients revealed that 10.3% of transvaginal mesh uses will result in transvaginal mesh erosion, precisely replicating the findings of other contemporary research on the subject.[2]

With complication rates so high, one might assume that users of transvaginal mesh had been made perfectly aware of the risks therein prior to consenting to the procedure.  However, that is not the case.  The manufacturers of transvaginal mesh products have been recently found to have misled users or to have withheld information regarding the safety of products, spurring a number of transvaginal mesh lawsuits across the country.

Currently, 56 transvaginal mesh products manufactured by 5 separate companies are under review by the FDA.

If you used a transvaginal mesh product and experienced transvaginal mesh erosion, please do not hesitate to contact our team of transvaginal mesh lawyers for a free case consultation.

At your convenience, you may reach our offices by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.  Our Transvaginal Mesh Lawsuit Information page is a great place to start if you have additional questions about Transvaginal Mesh.


[1] Badlani, G. et al. “Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review” Indian Journal of Urology 28.2 (April-June 2012): p129

[2] Ibid.

This shows that the FDA is more interested in protecting pharmaceutical companies than patients.  Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk.  A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug.  And allowing any American to use the untested drug carries more risk than the dozens or hundreds of people who would be in a test.

 

Also, note that some of these drugs are generics.  Which means that individuals injured by drugs that weren’t even tested still can’t sue the manufacturer.  And of course, there is no “fraud on the FDA” claim available…

 

  • In 2011, the FDA announced years’ worth of studies from a major drug research lab were potentially worthless.
  • About 100 drugs were on the U.S. market based in part on these tests.
  • The FDA let the drugs stay on pharmacy shelves with no new testing (in some cases until now).
  • As the FDA investigated and ordered re-tests, its European equivalent pulled seven drugs from the market.
  • The FDA says it has no evidence that any of the drugs were unsafe or that any patient has been harmed.
  • The FDA has never named the drugs, saying to do so would reveal trade secrets.
  • FDA Let Drugs Approved on Fraudulent Research Stay on the Market – ProPublica