Makers of dangerous implants used to surgically repair women’s pelvic problems would be subject to firmer safety requirements under the new Food and Drug Administration (FDA) proposal issued this spring.
After years of reports of pain, bleeding, and infection among women who have received vaginal mesh, the FDA says that plastic mesh used to repair pelvic collapse should be reclassified as a “high risk” medical device. If finalized, the change would require manufacturers to prove that their products are safe and effective before they can be sold.
The FDA, through a fast-track approval system, allowed products currently on the market because they were deemed similar to mesh used in hernia surgeries. Currently, the FDA classifies all pelvic mesh as a “moderate risk” device, which is not subject to the rigorous testing of high-risk implants. Under the FDA’s new proposal, companies would have to submit a premarket approval (PMA) application and submit clinical data proving their devices are safe and effective before gaining FDA approval. The agency took comments on the proposal through the end of July.
FDA’s Earlier Transvaginal Mesh Actions
These proposed orders are not the first time that the FDA has weighed in on mesh:
- October 2008 – FDA issued a FDA Public Health Notification about serious complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse and Stress Urinary Incontinence.
- July 2011 — The FDA provided an updated safety communication about serious complications associated with Pelvic Organ Prolapse repair with transvaginal mesh. At that time, the agency also released a review of urogynecologic surgical mesh adverse events and peer-reviewed scientific literature that identified serious safety and effectiveness concerns.
- September 2011 — The FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified as a “high risk” device and require premarket approvals.
- January 2012 — The FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies to address specific safety and effectiveness concerns.
Transvaginal Mesh Litigation
Thousands of women injured by transvaginal mesh, have filed lawsuit against the manufacturers of these dangerous products. In February, the Federal Judge who is handling most of the implant lawsuits concluded that one of the leading manufacturers of Transvaginal Mesh, Johnson & Johnson, destroyed thousands of documents regarding development of its pelvic-mesh implants. These documents would have included reports on patient testing of the mesh implants, could have shown whether participants suffered serious complications, and would have been relevant in the FDA approval process, had the company been required to prove the effectiveness and safety of the mesh.
Watts Guerra LLP is proud to pursue litigation for women harmed by these dangerous and defective surgical mesh products. Women who had a vaginal mesh or bladder sling implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have been put at needless risk and suffer catastrophic complications from these medical devices.
Written By:
Paige Boldt
Watts Guerra LLP
4 Dominion Drive, Bldg. 3, Suite 100
San Antonio, Texas 78257
Phone (210) 447-0500
© Watts Guerra LLP 2015
