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February 22, 2013 / Shehnaz M. Bhujwala

Thousands of Women Sue Surgical Mesh Manufacturers After Suffering Pain, Infections Following Transvaginal Surgery

The physical stresses placed on a woman’s body from childbirth, among other factors, can sometimes cause painful and complicated medical conditions such as Pelvic Organ Prolapse (“POP”) and Stress Urinary Incontinence (“SUI”). For decades, doctors have performed transvaginal surgery on thousands of women using surgical mesh products to treat these conditions and the surgery has become quite routine in recent years. However, the surgery is not without risk for women who undergo it.

surgical mesh

According to a recent ABC News article, thousands of women across the country who underwent this surgery are experiencing severe pain as well as bleeding, infections, and other adverse health complications from the surgery. Many of these women are now suing the manufacturers of the surgical mesh products used in their surgeries for, among other things, the failure to properly warn of the risks associated with use of surgical mesh. If these women were made aware of the health risks known to the manufacturers, they might have refused the surgery. But they were not provided all of the information available about the safety and efficacy of these surgical mesh products to make an informed decision about their treatment.

What is Surgical Mesh?

Surgical mesh is a screen, often metallic or polymeric, that is implanted in the body to reinforce soft tissue or bone, wherever weakness exists. The mesh is essentially cut to the desired shape and placed through an incision. It’s been used by doctors for hernias since the 1950s and by gynecologists since the 1990s for surgical treatment of SUI and the trans-vaginal repair of POP. Manufacturers later developed mesh products that were specifically designed for SUI and POP. In 1996, the Food and Drug Administration (“FDA”) approved the first surgical mesh specifically for use in SUI, and in 2002, the FDA approved the first surgical mesh product specifically for use in POP.

What are the Reported Complications of the Use of Surgical Mesh to Treat POP and SUI?

In a 2008 Public Health Notification, the FDA reported problems with the use of surgical mesh products to treat POP and SUI, but stated that these problems were “rare.” However, in July 2011, the agency issued an update where it admitted that it erred in its initial assessment, that problems with the use of these products were not “rare,” and it estimated the most common problems with mesh occurred in approximately 10% of women within a year of surgery. The FDA also concluded that transvaginally placed mesh to treat POP does not conclusively improve clinical outcomes over traditional non-mesh repair.

The July 2011 FDA report states:

From 2008 to 2010, the most frequent complications reported to the FDA from the use of surgical mesh devices for POP repair included vaginal mesh erosion (also called exposure, extrusion or protrusion), pain (including painful sexual intercourse known as dyspareunia), infection, urinary problems, bleeding, and organ perforation. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems. Many of the MDRs cited the need for additional intervention, including medical or surgical treatment and hospitalization. Vaginal shrinkage was not reported in the previous three year period corresponding to the 2008 PHN.

Between 2008 and 2010, there were seven reported deaths associated with POP repairs. Follow-up investigation on the death reports revealed that three of the deaths associated with POP repair were related to the mesh placement procedure (two bowel perforations, one hemorrhage). Four deaths were due to post-operative medical complications not directly related to the mesh placement procedure.

A Bellwether Case Suggests Massive Liability for Manufacturers of Surgical Mesh That Failed to Properly Warn Patients of the Risks Associated with Surgical Mesh.

ABC News reports that nearly six thousand lawsuits are winding their way through a consolidated federal court proceeding against several manufacturers of surgical mesh products used in the treatment of POP and SUI, while thousands of other lawsuits are pending in state courts around the country. Last year, the first of these lawsuits to go to trial resulted in a jury award of $5 million in damages for the plaintiff, Christine Scott, who suffered greatly after being implanted with the C.R. Bard Avaulta Plus Vaginal Mesh Implant and required nine revision surgeries, and an additional $500,000 to her husband for his own damages in suffering loss of intimacy with his wife. Several other “bellwether” cases are set for trial this year.

If you or a family member has suffered an adverse health condition from a surgical mesh product used to treat POP or SUI, please contact Khorrami, LLP to set up a confidential consultation.


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