Adverse Risks Associated with Vaginal Mesh

Surgical mesh implants used to repair pelvic organ prolapse (POP) have been linked to greater risk of painful and long-term complications than other treatments. Even worse, the risky transvaginal mesh (also called a patch) does not offer any clinical benefits compared to traditional methods, only increasing the risk for patients."There are clear risks associated with the transvaginal placement of mesh to treat POP," stated a deputy director at the FDA.

FDA Warning of Serious Complications

A July 2011 alert issued by the FDA warns of significant complications linked to transvaginal mesh patch, some of which require correctional surgery or may persist for the remainder of the woman's life. Thousands of reports of transvaginal mesh failure have been filed with the FDA.

Transvaginal Mesh Lawsuits Filed by Nearly 7,000 Victims

More than 6,750 federal and 500 state lawsuits have been filed against transvaginal mesh manufacturers by women who have suffered serious complications, and the numbers continue to grow.

Federal mesh cases have been consolidated into four multidistrict litigations (MDL) based on the manufacturer they're filed against. Transvaginal mesh MDL pretrial proceedings are in full swing and Chief Judge Joseph R. Goodwin has set a trial date. As of October 2012, the number of suits filed against each manufacturer continues to increase rapidly:

• 1,697 cases filed against AMS
• 1,725 cases filed against Johnson & Johnson's Ethicon Division
• 1,114 cases filed against Boston Scientific
• 1,256 cases filed against C. R. Bard
• 40 cases filed against Coloplast Corp

What Can You Do?

You do not have to accept these harmful side effects as a consequence of treatment for POP. Medical device manufacturers have a duty to ensure the safety of their products for patients. When they fail to do so, you can hold them responsible for the injuries their products caused by filing a claim for damages. Compensation cannot reverse the complications you have suffered, but it can offset the cost of additional medical treatment and other financial burdens caused by the defective transvaginal mesh implant.

History of Transvaginal Mesh Failure

2012, March – Discovered that Johnson & Johnson Sold Mesh Without FDA Approval
Johnson & Johnson (J&J), makers of several brands of transvaginal mesh, reportedly sold one type – Gynecare Prolift – from 2005 to 2008 without the device being approved by the FDA. The company intentionally ignored the approval process. Legal experts believe this revelation about Prolift's unapproved sales will force J&J to pay even more to resolve lawsuits – a benefit much-deserved by victims of Prolift injuries.

2012, January – FDA Demands Further Research of TVM
The FDA ordered transvaginal mesh implant manufacturers to study the risks associated with the device. The results of this research could help strengthen suits filed by women who suffered complications of their transvaginal mesh patches. Additionally, if the findings mirror the current research and link many serious side effects to the implant, it could result in the risky patch being removed from the market. This would ensure no more women are harmed by transvaginal mesh.

2012, January – Congress Reps Push for Hearing to Review Transvaginal Mesh Dangers
The Energy and Commerce Committee hearing should address "whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the…intravaginal mesh," said a letter by congressional representatives. Using harmful transvaginal mesh patches as an example, the hearing could result in reformed FDA device rules that would improve medical device safety for the public.

2011, December – Doctors Asked to Limit Use of Mesh
Experts from the Committee on Gynecologic Practice have called for limited use of the mesh patch by doctors who seek to repair POP. The recommendation is based on the painful and serious complications suffered by many women who have received the patch. The Committee stated that doctors should only use the implant in cases where POP is a major risk for the woman.

2011, July – FDA Alert
Complications associated with the transvaginal placement of surgical mesh are found to not be rare, a change from the FDA's warning in 2008. The FDA announces that surgical mesh treatment of POP may be no more effective than traditional non-mesh repair, in addition to posing great risks for the patient. Between 2008 and 2010, the FDA received 2,874 more reports of adverse complications linked to surgical mesh repair of POP and stress urinary incontinence (SUI).

2011, May – Study Published in the New England Journal of Medicine
Research revealed complications associated with the transvaginal mesh implant. Compared to colporrhaphy, the traditional method of stitching connective tissues back together, the surgical mesh had a higher risk of defect, including:

• 7 times the risk of bladder perforation
• Nearly twice the risk of urinary incontinence (loss of bladder control)
• 3.2 percent of women required follow-up surgery to correct problems

2010, October – Study Published in Obstetrics & Gynecology journal
Surgical mesh-related complications were so extensive for participants that the study was terminated. According to the article, 15 percent of study participants who received the transvaginal patch experienced erosions. Other complications included two cystotomies (bladder incision) and one blood transfusion.

2008, October – FDA Alert
Complications are associated with the transvaginal placement of surgical mesh to treat POP and SUI. Between 2005 and 2008, the FDA received more than 1,000 reports of complications from nine surgical mesh manufacturers. However, at the time the FDA cited the complications as rare.

Did you receive a transvaginal mesh implant and experience serious complications?

If you received a transvaginal mesh implant and have experienced complications due to the device or to mistakes made during surgery, you have a right to compensation for your pain and suffering. The manufacturers of dangerous mesh implants should be held accountable for injuries caused by their faulty products. Please contact one of our experienced medical device attorneys for a free consultation during which we can discuss your experience and the best course for your case.

Manufacturers of defective surgical mesh products include:

• C. R. Bard
• Boston Scientific

• American Medical Systems (AMS)
• Gynecare/Ethicon, Inc., Johnson & Johnson