Transvaginal Mesh Recall
Given the growing reports of transvaginal mesh injuries and mounting litigation, many are wondering: has a transvaginal mesh recall been issued?
The U.S. Food and Drug Administration (FDA) has received over 4,000 reports of women who suffered from adverse effects from a vaginal mesh implant, including problems such as mesh erosion, infection, pain, urinary problems, recurrence of pelvic organ prolapse or urinary incontinence, and painful intercourse. Though the agency has issued several warnings about vaginal mesh side effects, the FDA has not issued an official transvaginal mesh implant recall.
In 2008, the agency issued its first alert about transvaginal mesh complications, though the FDA said that the complications were “rare.” In 2011, the FDA changed their stance, after receiving thousands of adverse event reports. The FDA’s updated warning states that vaginal mesh problems are of “continuing serious concern.” The agency said that the use of transvaginal mesh to treat pelvic organ prolapse was a “great risk” with “no evidence of greater clinical benefit.”
Vaginal Mesh Manufacturers Issue Mesh Recall
Though the FDA has not issued an official mesh implant recall, various mesh manufacturers have stopped selling certain models of vaginal mesh implants.
In 1999, Boston Scientific issued the first transvaginal mesh recall of its ProtoGen implant after only three years on the market. It was a prototype of vaginal mesh that many other manufacturers later based their designs on. Many models of vaginal mesh are approved through the FDA’s expedited 510(k) program, which allows them to go to market without clinical testing if they’re deemed similar enough to a predicate device. Though the ProtoGen was recalled, later models of transvaginal mesh were not. More recently, in June 2012, Johnson & Johnson subsidiary removed its Gynecare line of pelvic mesh devices from the market. The company is now facing more than 1,400 transvaginal mesh lawsuits, alleging that the Ethicon vaginal mesh caused women to suffer serious injuries.
In July 2012, C.R. Bard stopped selling its Avaulta Plus vaginal mesh implant. In July 2012, a plaintiff who received an Avaulta Plus vaginal mesh implant and filed a lawsuit against the manufacturer received a $5.5 million jury verdict for damages.
Despite Lack of Pelvic Mesh Recall, Transvaginal Mesh Lawsuits Continue
Recipients of defective transvaginal mesh implants are filing lawsuits against various manufacturers to seek compensation for their expenses and injuries. More than 8,000 vaginal mesh lawsuits have been filed in federal and state courts, alleging failure to warn, defective design and negligence. If you received a vaginal mesh implant and suffered complications, speak to a mesh lawyer at our firm today to learn more about how you can protect your legal rights. You may be entitled to compensation for your medical expenses, lost wages, pain and suffering and more. Call (877) 779-1414 to learn more.