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News & Commentary on Prescription Drug & Medical Device Lawsuits

Infection from Transvaginal Mesh

By Jared Fink on Posted in Vaginal Mesh

In 2007, medical researchers Matthew E. Falagas et al. published a report outlining bacterial infections that may occur as a result of transvaginal mesh use.  To clarify, transvaginal mesh (TVM) is a man-made substitute for human tissue that is used in the surgical repair of a damaged uterine or vaginal wall usually following pelvic organ prolapse.

To compile data for the report, Falagas et al. reviewed the national medical research database curated by the National Institutes of Health, PubMed, for articles regarding “the incidence, clinical manifestation, and management of vaginal mesh-related infections.”[1]

From their research, Falagas et al. found that mesh-related infections occurred as high as 8% of the time, while vaginal mesh erosion occurred at a rate as high as 33% in some studies.[2]

Signs that one has a transvaginal mesh-related infection are “Non-specific pelvic pain, persistent vaginal discharge or bleeding, dyspareunia, and urinary or faecal incontinence.”[3]  And though most mesh-related infections may be cured with antibiotics, many women face these risks unknowingly due to the fact that several transvaginal mesh manufacturers have failed to warn physicians of the rates at which these complications occur.

As a result of this, a number of transvaginal mesh lawsuits are currently being filed either as a result of a patient’s experiencing vaginal mesh erosion or mesh-related infection through no fault of their own.  If you used transvaginal mesh and experienced one of these complications or another TVM side effect, please do not hesitate contact our team of Transvaginal Mesh Lawyers at Ketterman, Rowland, and Westlund Trial Attorneys for you may be entitled to significant financial compensation.

At your convenience, you may reach our offices by phone at (888) 315 – 3997 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] Falagas, ME et al. “Mesh-related infections after pelvic organ prolapse repair surgery” European Journal of Obstetrics & Gynecology and Reproductive Biology 134 (2007) 147–156

[2] Ibid.

[3] Ibid.

2009 – Complications of TVM Use in 20% of Cases

By Jared Fink on Posted in Vaginal Mesh

In 2009, Robert M. Freeman and Gunnar Lose published a report aiming to weigh the benefits against the risks associated with transvaginal mesh use.  Transvaginal mesh (TVM) is a synthetic tissue substance used in the surgical repair of the vaginal or uterine wall following pelvic organ prolapse or another such ailment.

Published in The International Urogynecology Journal, the Freeman and Lose (2009) report was titled simply “The great mesh debate” and begins by asserting that there is an insufficient amount of research regarding transvaginal mesh to conclude anything about its safety: The evidence for most efficacy and safety outcomes was too sparse to provide meaningful conclusions about the use of mesh/graft in anterior and/or posterior vaginal wall prolapse surgery”[1]

Freeman and Lose suggest, rather, that the use of TVM “should be considered experimental … until such evidence is available that patients can be [counseled] accordingly.”[2]

Here is an excerpt from the report I found particularly poignant:

“The rationale for the use of mesh relates to the poor outcomes of traditional prolapse surgery especially for the anterior compartment. [Prominent medical researcher]Te Linde stated over 40 years ago that: ‘every honest surgeon of extensive and long experience will have to admit that he/she is not entirely and absolutely satisfied with his/her long-term results of his/her operations for prolapse and allied conditions’ [7]. It could be argued that not much has changed with 40% failure rates being quoted for anterior repair [8].”[3]

Though to be fair, Freeman and Lose also acknowledge “that it is relatively easy to publish a case report of a severe complication but that this can paint a falsely pessimistic picture.”[4]

However, the evidence that TVM use is dangerous and causes unnecessary complications is clear: about 20% of women that use TVM will require a second surgery to correct complications caused by the first procedure.[5]  “While these re-operation rates are not synonymous with failure, nonetheless, one would imagine that if after ‘failed’ primary surgery the symptoms were bothersome then patients would seek further treatment, whether that be with vaginal pessaries or surgery.”[6]

Suggesting that gynecologists around the country keep records of all “good” and “bad” outcomes of TVM use, Freeman and Lose write that eventually, doctors will be able to adequately inform patients about the safety of TVM.  In the meantime, we can plainly examine the available data: it is now widely-known that TVM use results in vaginal mesh erosion at least 10% of the time.

Due to the fact that many TVM manufacturers have failed to warn users of these risks, a number of TVM lawsuits are currently being filed.  If you used TVM and experienced vaginal mesh erosion or another TVM side effect, please do not hesitate to contact our team of TVM lawyers at Ketterman, Rowland, and Westlund Trial Attorneys.

For a free consultation, you may reach our offices by phone at (888) 315 – 3997 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] Freeman, RM & Gunnar, L “The great mesh debate” Int Urogynecol J (2009) 20:889–891

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Ibid.

Danger of Transvaginal Mesh

By Jared Fink on Posted in Vaginal Mesh

A 2008 report by Dr. Assia A. Stepanian et al. published in The Journal of Minimally Invasive Gynecology has outlined some of the complications associated with use of transvaginal mesh (TVM), a synthetic substitute for human tissue used in surgical repair of the uterine or vaginal wall following pelvic organ prolapse.  As of yet, polypropylene TVM products have been associated with a rate of complication over 10%, with silicone transvaginal mesh products’ complication rates exceeding even 20%.

The Stepanian et al. (2008) piece was titled “Risk of Mesh Extrusion and Other Mesh-Related Complications After Laparoscopic Sacral Colpopexy with or without Concurrent Laparoscopic-Assisted Vaginal Hysterectomy: Experience of 402 Patients” and may be found online by following the link above.

As vaginal mesh erosion is the most common complication of transvaginal mesh use, it is understandable that this was the focus of the Stepanian (2008) piece.

Of the 402 patients studied, only about 1.2% experienced vaginal mesh erosion or TVM extrusion.[1]  This surprisingly low figure may, however be due to the fact that the 402 patients studied had all undergone sacral colpopexy, while studies finding rates of vaginal mesh erosion over 10% included any and all uses of transvaginal mesh.

Due to the fact that over 1000 adverse events related to transvaginal mesh use have been reported to the United States Food and Drug Administration, and a number of transvaginal mesh manufacturers have failed time and again to warn users of the risks and frequency of risks associated with the use of their products, a number of TVM lawsuits have been filed.

If you used transvaginal mesh and experienced a negative side effect such as vaginal mesh erosion, please do not hesitate to contact our team of transvaginal mesh lawyers at Ketterman, Rowland, and Westlund Trial Attorneys.  You may be entitled to significant financial compensation on your behalf due to the lack of oversight at these companies that caused your injuries.

For a free, no-obligation case consultation, you may reach our offices either by phone at (888) 315 – 3997 or by e-mail at justinian@dangerousdrugs.us.

We have the experience, resources, and skills required to fight even the largest companies for the justice you deserve.  Our Transvaginal Mesh Lawsuit Information page is a great place to start if you have additional questions about Transvaginal Mesh.

[1] Stepanian, A.A. et al. “Risk of Mesh Extrusion and Other Mesh-Related Complications After Laparoscopic Sacral Colpopexy with or without Concurrent Laparoscopic-Assisted Vaginal Hysterectomy: Experience of 402 Patients” Journal of Minimally Invasive Gynecology 2008 Mar-Apr;15(2):188-96.

1998 – 12% of TVM Surgeries Result in Vaginal Mesh Erosion

By Jared Fink on Posted in Uncategorized, Vaginal Mesh

A 1998 report published in Obstetrics and Gynecology titled “Mesh erosion after abdominal sacrocolpopexy” by Dr. Neeraj Kohli et al. illustrates clearly an all-too-common complication of transvaginal mesh use.

Transvaginal mesh (TVM) is synthetic “tissue” used to “mimic,” if you will, human flesh, used in the surgical reconstruction of the vaginal or uterine wall following pelvic organ prolapse or another similar ailment.  In the last 15 years, however, a great number of reports have been published that show an extremely high rate of severe complications related to transvaginal mesh use, the most common of which is vaginal mesh erosion.  Vaginal mesh erosion occurs in 10% of women who used polypropylene TVM; 23.8% of women experienced vaginal mesh erosion with silicone TVM.

In 1998, Kohli et al. performed a retrospective analysis of patients who had undergone sacrocolpopexy by one surgeon in an 8 year period.  Of the 57 patients who had undergone that surgical procedure between 1990 and 1998, 12% “had erosions,”[1] and the mean time it took for erosions to occur was 14 months.[2]

Though this research was published 15 years ago and clearly shows a high rate of complication accompanying the use of TVM, and though other many studies have reached similar conclusions about the risks associated with transvaginal mesh, many manufacturers of TVM products have yet to provide warning labels explaining these risks.

As it currently stands, over 1000 reports of adverse events related to transvaginal mesh have been made to the United States Food and Drug Administration; prompting the re-evaluation of 56 TVM products by 5 manufacturers.

If you or a loved one used transvaginal mesh and experienced vaginal mesh erosion or another TVM side-effect, you may be entitled to significant financial compensation through a transvaginal mesh lawsuit.  At your convenience, you may contact our team of transvaginal mesh lawyers at Ketterman, Rowland, and Westlund Trial Attorneys for a free case consultation at (888) 315 – 3997 or by e-mail at justinian@dangerousdrugs.us.

We have the experience, resources, and skills required to secure 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] Kolhi, N et al. “Mesh erosion after abdominal sacrocolpopexy” Obstetrics & Gynecology Volume 92, Issue 6, December 1998, Pages 999–1004

[2] Ibid.

Complications of Transvaginal Mesh Use

By Jared Fink on Posted in Uncategorized, Vaginal Mesh

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 at Ketterman, Rowland, and Westlund Trial Attorneys for a free case consultation.

At your convenience, you may reach our offices at (888) 315 – 3997 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.

Rates of Complication with Transvaginal Mesh Exceedingly High

By Jared Fink on Posted in Uncategorized, Vaginal Mesh

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 at Ketterman, Rowland, and Westlund Trial Attorneys for a free, no-obligation case consultation.

At your convenience, you may reach our offices by phone at (888) 315 – 3997 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: “Elderly Abused at 1 in 3 Nursing Homes”

By Jared Fink on Posted in Uncategorized

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 at Ketterman, Rowland, and Westlund Trial Attorneys for more information or a free case consultation.

At your convenience, you may reach our offices by phone at (888) 315-3997 or by e-mail at justinian@dangerousdrugs.us.  We have the experience, resources, and skills required to win the justice you deserve.

10% Rate of Vaginal Mesh Erosion with Transvaginal Mesh

By Jared Fink on Posted in Uncategorized, Vaginal Mesh

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 at Ketterman, Rowland, and Westlund Trial Attorneys by phone at (888) 315 – 3997 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.

Complications in the removal of transvaginal mesh

By Jared Fink on Posted in Uncategorized, Vaginal Mesh

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 at Ketterman, Rowland, and Westlund Trial Attorneys either by phone at (888) 315 – 3997 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.

Complications of Transvaginal Mesh: a case report

By Jared Fink on Posted in Uncategorized, Vaginal Mesh

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 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 well.  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 at Ketterman, Rowland, and Westlund Trial Attorneys for a free, no-obligation case consultation.

At your convenience, you may reach our offices by phone at (888) 315 – 3997 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.