More than 3,300 Boston Scientific transvaginal mesh lawsuits are currently pending in federal court. This is not the first time Boston Scientific has faced an onslaught of lawsuits involving transvaginal mesh. In 1999, the company recalled the ProteGen mesh. After the recall, Boston Scientific continued developing new meshes that were very similar to the ProteGen. Now, many women allege that the company failed to warn about the potential risks of the implants.
Free Boston Scientific Transvaginal Mesh Lawsuit Evaluation: If you or your loved one was injured by transvaginal 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.
Boston Scientific Invents First Transvaginal Mesh
In August 1996, the U.S. Food and Drug Administration (FDA) approved the first-ever transvaginal mesh product — the ProteGen sling, manufactured by Massachusetts-based medical device company Boston Scientific Corp. The slender, hammock-like implant was made from polyester coated with bovine collagen. It was implanted through transvaginal incisions in the vagina and anchored to the patient’s pelvic bones to support the bladder and urethra. This is a treatment for stress urinary incontinence, a condition that affects more than 5 million Americans.
Seeing the enormous market potential for the product, Boston Scientific pushed for a fast approval of the ProteGen. The FDA approved the ProteGen based on a 510(k) application, which allows new devices that are “substantially equivalent” to an older device to be sold without requiring rigorous safety studies. Boston Scientific’s application relied on hernia mesh, which had never been approved for treating incontinence, and a 90-day study of the ProteGen sling in rodents. After 22 months on the market, more than 17,000 women were implanted with Boston Scientific’s transvaginal mesh.
Boston Scientific Transvaginal Mesh Recall
Unfortunately, problems with Boston Scientific’s transvaginal mesh emerged almost immediately. Within the first few months, hundreds of adverse events were reported. In June 1998, the FDA inspected the company’s manufacturing plant and found that Boston Scientific was only reporting two-thirds of the total complaints they were receiving, and only when the device had to be surgically removed.
On January 22, 1999, Boston Scientific recalled the ProteGen transvaginal mesh. The company said it “does not product outcomes that are consistent with the company’s standard of performance,” and the FDA said it “does not appear to function as intended.”
After the recall, more than 500 women filed lawsuits against Boston Scientific for their transvaginal mesh injuries. Many women experienced excruciating pain when the mesh sliced through their vagina, causing bleeding, infection, and other complications that made it impossible to sit down, stand, or walk. Many women required surgery to remove the mesh.
Injuries and Complications of Transvaginal Mesh
After Boston Scientific recalled the ProteGen transvaginal mesh, the FDA continued approving new meshes that were “substantially equivalent” or very similar to the ProteGen. They did not require more safety studies until early 2012. This is concerning, because the FDA published Safety Communications regarding transvaginal mesh injuries and complications in 2008 and 2011.
Transvaginal mesh injuries and complications include:
- Erosion of the mesh through the vaginal wall
- Pain (chronic or only during sexual intercourse)
- Organ damage (bladder, urethra, ureter, uterus, bowel)
- Incontinence or recurrent prolapse
- Nerve damage
- Mesh contraction or shrinkage
- Complications of surgery
- Additional surgery to remove mesh
- Permanent complications or disfigurement
Boston Scientific Transvaginal Mesh Litigation in Federal Court
If you were injured by Boston Scientific transvaginal mesh, you are not alone. Boston Scientific is currently facing more than 3,300 lawsuits in a federal Multi-District Litigation (MDL) in the U.S. District Court for the Southern District of West Virginia. If you decide to file a transvaginal mesh lawsuit, your lawsuit will remain independent, but it will likely be transferred into the following court:
Types of Boston Scientific Transvaginal Mesh
- Boston Scientific Arise
- Boston Scientific Pinnacle
- Boston Scientific Advantage Fit
- Boston Scientific Lynx
- Boston Scientific Obtryx
- Boston Scientific Prefyx PPS
- Boston Scientific Solyx
Do I Have a Boston Scientific Transvaginal Mesh Lawsuit?
The Product Liability & Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in transvaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new lawsuits in all 50 states.
Free Transvaginal Mesh Lawsuit Evaluation: Again, if you or a loved one was injured by a Boston Scientific transvaginal mesh, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.