Has There Been A Transvaginal Mesh Recall?
Are you wondering if a transvaginal mesh recall has been issued? Transvaginal mesh implants can cause serious complications and adverse effects including erosion, infection, pain, urinary problems, and recurrence of organ prolapse and incontinence. The U.S. Food and Drug Administration (“FDA”) has received approximately 4,000 reports of vaginal mesh injuries, and issued two safety warnings about pelvic mesh implants. Although in 2008, the FDA issued an alert cautioning doctors about vaginal mesh risks, however the agency went so far as only to call the complications “rare.” In 2011, the FDA reassessed the earlier alert, and warned that pelvic mesh complications were, in fact, “not rare” but rather of “continuing serious concern.” Despite these warnings, the FDA has not issued an official recall of vaginal mesh implants.
Certain transvaginal mesh manufacturers have stopped selling or issued vaginal mesh recalls in the past:
- In 1999, Boston Scientific voluntarily recalled its ProteGen implant, a prototype of transvaginal mesh, after only three years on the market. Unfortunately, other manufacturers based their own transvaginal mesh designs on the ProteGen and used the FDA’s expedited 510(k) approval process to get their products approved without having to conduct clinical trials because they were deemed similar to the ProteGen. Though the ProteGen vaginal mesh was recalled, the products based on its design were not.
- Recently, in June 2012, Johnson & Johnson subsidiary Ethicon, one of the manufacturers of vaginal mesh, announced a withdrawal of four of its Gynecare vaginal mesh implants from the market because of safety issues. Hundreds of patients who received Ethicon pelvic mesh implants and suffered complications are filing lawsuits against the manufacturer in federal and state courts. More than 600 women have filed lawsuits claiming that the Ethicon pelvic mesh implants caused their injuries.
- On July 1, 2012, C.R. Bard, another vaginal mesh manufacturer, stopped selling its Avaulta Plus pelvic mesh implant.
In September 2011, an advisory panel to the FDA recommended that transvaginal mesh be reclassified as high-risk so that manufacturers would be forced to undergo rigorous testing in order to receive FDA approval. In August that year, a consumer advocacy group petitioned the FDA to ban all transvaginal mesh marketing, recall vaginal mesh products, and require future pelvic mesh devices to conduct a clinical study proving the devices’ safety before being allowed on the market.
Given the dangers associated with transvaginal mesh implants, we are disappointed that the FDA has not yet issued a recall of pelvic mesh devices. However, if you received a defective vaginal mesh implant and experienced complications, you can file a vaginal mesh lawsuit to seek compensation for your injuries. You may be entitled to compensation for your lost wages, medical expenses, pain and suffering and more. In July 2012, a California jury awarded a recipient of a defective Avaulta Plus mesh implant $5.5 million for her injuries. Contact a pelvic mesh lawyer to learn more about how to file a transvaginal mesh lawsuit. Call our lawyers today for a free case review: (877) 779-1414.