Surgical Mesh Causes Contoversey, Death.

In 2002, the FDA Used shortened approval process to approve the a type of Johnson & Johnson surgical mesh. The mesh supports the muscles in the pelvis that can no longer support the pelvic organs and keep them in place. Plantiffs in a lawsuit against Johnson & Johnson complain of pain so intense it is interfering with their ability to go to work, sleep or live a normal life.

On July 13, the FDA annouced a rise in injuries related to the surgical mesh. It recently warned that the mesh should be reclassified from a moderate risk to high surgery, however to make that change official that would require new clinical data.

That process has begun. A two day hearing with a panel of FDA advisors. They are reviewing weather the mesh is safe for the Pelvic organ prolapse, or POP, and weather manufacturers must submit more data about it’s safety, in order to keep these products on the market.

They will also review other types of mesh that are used for urinary incontinence. These hearings are a result of a report in a US Institute of Medicine report. They are using it to scrap the 501(k) process for devices that are considered moderate risk. Currently, the process allows devices, much like the mesh, to be sold in the market as long as the manufacturers demonstrate that the devices are “substantially equivalent” to other items already in the marketplace. The IOM recommends a process that gives patients a reasonable assurance of not only the effectiveness, but also the safety of these moderate risk devices.

“The clinical effectiveness of surgical mesh for transvaginal repair of POP has not been demonstrated,” said William Maisel, deputy director of the FDA Center for Devices and Radiological Health, in an interview. “We believe proper studies would need to be done.”

Many manufacturers of the mesh do not believe that the mesh should be reclassified. The Group said that the mesh is “safe and effective, that serious adverse events remain rare and it is a valuable treatment option for women”. A Johnson & Johnson spokesman declined comment on the litigation. Another company that makes Avaulta pelvic mesh, Bard, who has 190 lawsuits of its own.

The mesh that is under review by the FDA’s avisors, supports the tissues in the pelvic floor. That become weakened or streched by childbirth or age. This weakening or stretching causes organs such as the bladder, rectum, and rectum to bulge into the vagina. Each year over 2 million women receive a diagnosis of vaginal prolapse.

In just the two years 2008 to 2010, there were 1,503 reports to the FDA of injury, malfunction, or death related to this surgery. That is a 500% increase over the previous three years. Injuries reported include, but are not limited to, urinary problems, infection, organ perforation, and mesh erosion.

The mesh was first used in the 1950s to repair abdominal hernias. More than forty years later, in 1996, the FDA allowedthe mesh to be used for stress urinary incontinence. Then in 2002, the FDA cleared the use of surgical mesh for prolapse.

The FDA review is looking at over 100 studies that examined the mesh in almost 12,000 women. Ten percent had shown mesh erosion in just twelve months. The studies also included seven women’s deaths.

Have you or someone you care about been affected by vaginal prolapse and the surgical mesh? Has a loved one undegone this vaginal prolapse surgery and is dealing with complications? Contact The Law Firm of Michael V. Favia & Associates immediately. You can contact us either through the email form on this page or call our office at (773) 631-4580.

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