A U.S. Food and Drug Administration (FDA) advisory panel is meeting next week to discuss problems associated with vaginal repair of pelvic organ prolapse (POP) in women using non-absorbable surgical mesh.
The panel is meeting after Public Citizen, a consumer advocacy group, petitioned the FDA to ban surgical mesh for transvaginal repair of POP.
Tens of thousands of women have suffered serious side effects when their surgeon used a transvaginal technique to implant the mesh. Patients report complications including vaginal tissue erosion, neuromuscular disorders, severe pain, infection, painful sexual intercourse, bleeding and organ perforation. In some cases, women have had to be hospitalized to treat the complications or to have the mesh surgically removed. Surgery to remove the mesh is often complicated because the mesh becomes embedded into the vaginal tissue. Some women have required two or more surgeries.
Public Citizen says that the transvaginal repairs using surgical mesh should be banned because this technique offers no benefits in comparison to other surgical options and because there is a high rate of serious complications, some of which are permanent and life-altering.
Currently, there are several manufacturers that market surgical mesh products for transvaginal repair of POP. These include:
- Gynecare Prolift Total, Anterior, and Posterior Pelvic Floor Repair Systems
(Ethicon, Inc., Somerville, NJ)
- Gynecare Prolift +M Total, Anterior, and Posterior Pelvic Floor Repair Systems
- Gynemesh Prolene Soft Nonabsorbable Synthetic (Ethicon, Inc.)
- AMS Elevate Anterior and Apical Prolapse Repair System (American Medical
Systems, Inc., Minnetonka, MN)
- Pinnacle Pelvic Floor Repair Kits (Boston Scientific Corp., Marlborough, MA)
- Avaulto Support System (C.R. Bard, Inc., Covington, GA)
- Polyform Synthetic Mesh (Proxy Biomedical, Ltd., Galway, Ireland)
The FDA 501(k) premarket notification system, a “fast track” in bringing a medical device to market, is again criticized with this mesh debacle. Like other medical devices, including the DePuy hip implant that has been recalled, surgical mesh systems were allowed by the FDA to come onto the market without clinical data which proved that the devices were safe and effective. All the while, the manufacturers and marketers promoted the devices while tens of thousands of women were harmed.
In recent months, more than 100 women have filed suit against the mesh system manufacturers seeking compensatory and punitive damages. The lawsuits claim that the companies were negligent in the defective product design.
This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are personal injury law firm that represent product liability and medical malpractice cases. With our help, you may receive compensation for your damages.
Source:Petition to Ban Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse, Public Citizen, August 25, 2011