The first surgical mesh recall occurred in 1999, when Boston Scientific recalled the ProteGen. Since then, the FDA has approved dozens of surgical meshes that are very similar to the ProteGen, but most of these surgical meshes have not been recalled. Several have been “withdrawn” from the market by Johnson & Johnson / Ethicon and C.R. Bard. This is concerning, because more than 10,000 women have filed lawsuits alleging that the manufacturers of surgical mesh did not adequately warn them about the potential risk of side effects.
Free Surgical Mesh Lawsuit Evaluation: If you or your loved one was injured by surgical mesh, contact our law firm immediately for a free case consultation. If you file a lawsuit, you could receive compensation for your injury, medical expenses, and more.
Surgical Mesh Recall
Surgical mesh is a type of implant that can be made from synthetic or biological fibers that are woven together into a porous fabric. Surgical meshes were originally developed to repair hernias. Then, in 1996, Boston Scientific developed the first surgical mesh to be used for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Called the ProteGen mesh, it was designed to be implanted through transvaginal incisions in the vagina and abdomen using large needles. Surgical mesh treats POP and SUI by supporting muscles in the pelvic floor like a hammock or a sling.
Unfortunately, the ProteGen was plagued by adverse events. Hundreds of women were severely injured by mesh erosion and vaginal dehiscence (disembowelment through ruptured incisions in the vagina). As a result, Boston Scientific recalled the ProteGen in 1999. It was the first official surgical mesh recall.
Over the next decade, the FDA approved dozens of new vaginal meshes that were “substantially equivalent” to the ProteGen — a recalled surgical mesh — without requiring new safety studies. Although some of these have been “withdrawn,” they have not been recalled. Many women are angry about this, because the same injuries associated with the ProteGen have been linked to surgical mesh that is currently implanted in their body.
Surgical Mesh “Withdrawn” From the Market
In January 2012, the U.S. Food and Drug Administration (FDA) asked 31 manufacturers of surgical mesh to conduct new safety studies. Within a few months, Johnson & Johnson / Ethicon Gynecare and C.R. Bard “withdrew” several types of surgical mesh. According to Johnson & Johnson, the decision was made in light of “changing market dynamics” and not a surgical mesh recall.
Boston Scientific surgical mesh recalls:
- Pinnacle Pelvic Floor Repair Kit
C.R. Bard has withdrawn:
- Avaulta Solo Synthetic Support System
- Avaulta Solo Biosynthetic Support System
- Avaulta Plus Biosynthetic Support System
- Avaulta Biosynthetic Support System
Johnson & Johnson / Ethicon has withdrawn:
- Gynecare Prolift
- Gynecare Prolift + M Kit
- Gynecare TVT Secure
- Gynecare Prosima Pelvic Floor Repair System Kit
- Gynecare Gynemesh (changed label to limit use to abdominal procedures)
Do I have a Surgical Mesh Lawsuit?
The Product Liability & Defective Medical Device Litigation Group at our law firm is an experienced team of trial attorneys that focus on the representation of plaintiffs in surgical mesh lawsuits. We are handling individual litigation nationwide and currently accepting new lawsuits in all 50 states.
Free Surgical Mesh Lawsuit Evaluation: Again, if you or a loved one was injured by surgical mesh, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.