Medical Device Lawyer and Ohio Pelvic Mesh Attorney discusses the FDA mandate to discontinue transvaginal mesh sales
The U.S. Food and Drug Administration (FDA) has ordered all manufacturers of surgical mesh products used for the transvaginal repair of pelvic organ prolapse to stop selling the devices immediately. Boston Scientific and Coloplast are the last two companies currently making the transvaginal mesh products.
The FDA stated the companies have not demonstrated “reasonable assurance of safety and effectiveness” for the pelvic mesh devices they market and distribute. The FDA has warned patients before about the risks of pelvic mesh implants. The safety agency classified transvaginal mesh as “high-risk” in 2016. Pelvic Mesh injury and transvaginal complications include the following:
The FDA notes women with transvaginal mesh implants should continue with routine follow-ups with their physician. Revision surgeries are often necessary when complications occur, though can present a number of health risks. Consumer safety lawyers and your Ohio pelvic mesh attorney can discuss legal action following transvaginal mesh injuries.
Joe Lyon is an experienced Cincinnati Medical Device Recall Lawyer and Ohio Pelvic Mesh Attorney reviewing Transvaginal Mesh Implant Injury Lawsuits for plaintiffs nationwide.
Numerous product liability and personal injury lawsuits have been filed over vaginal mesh injury and pelvic mesh defects. The transvaginal mesh produced by medical device companies is a synthetic implant meant to strengthen weakened pelvic muscles. But the mesh implants have been known to lead to serious health issues and revision surgeries.
Johnson & Johnson, Boston Scientific and Coloplast have been up against consumer protection attorneys and medical device lawsuits that allege the companies knew of the risks of their defective surgical mesh products and still sold the products to patients. In fact, several medical device manufacturers are currently paying nearly $8 billion to resolve injury claims of more than 100,000 implanted women.
For many years, women implanted with pelvic mesh devices have suffered various injuries such as mesh erosion, infection, mesh migration, organ perforation, and chronic pain. The FDA has decided the risks of transvaginal mesh products outweigh the benefits and is halting the sales of pelvic mesh devices for repairing pelvic organ prolapse. Some mesh products will still be on the market for other operations.
Gynecologists have used surgical mesh to repair pelvic organ prolapse since the 1970s. The surgical mesh is implanted in the vaginal wall, and has caused bleeding, severe pain and infection. Many women have required revision surgery to deal with mesh injury complications. Transvaginal mesh implants used in pelvic organ prolapse surgery tends to be larger and pose more risks than other mesh products. Even the smaller mesh devices have a complication rate of 5 to 15 percent, which is unacceptably high. The FDA received over 10,000 complaints about pelvic mesh product injury as of last year.
Injured plaintiffs have settled lawsuits against device manufacturers, and litigation continues for those affected by defective pelvic mesh devices. The Lyon Firm and your Ohio pelvic mesh attorney can assist in recovering rightful compensation related to medical expenses, pain and suffering, and long-term disability.
If you or a loved one has suffered an injury due to a defective mesh device, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, an Ohio pelvic mesh attorney, and he will help you answer critical questions regarding transvaginal mesh injury lawsuits.