There are many brands of surgical mesh, transvaginal mesh, and bladder slings on the market, but there have been recalls of very few. One product that was the subject of a vaginal mesh recall is Boston Scientific’s ProteGen Sling.
Boston Scientific ProteGen Sling Recall
Cleared for marketing by the U.S. Food and Drug Administration (FDA) in 1997, the ProteGen Sling was “rushed to market for ﬁnancial reasons without adequate premarket clinical trials,” according to the American Journal of Obstetrics & Gynecology. Boston Scientific issued a voluntary vaginal mesh recall of the ProteGen Sling in 1999 after having received thousands of complaints. (Go here for details of the circumstances behind the vaginal mesh recall of another Boston Scientific mesh product.
ObTape Mesh Taken Off Market
Another mesh product, ObTape, was also taken off the market by its manufacturer. There was no vaginal mesh recall of ObTape, however. Rather, its manufacturer, Mentor Corporation (a company that was eventually taken over by Johnson & Johnson), discontinued the product a few years ago.
ObTape was one of the products used in the “intravaginal slingplasty” procedures (also known as Tension-Free Vaginal Tape procedures or “TVT” procedures) that doctors began performing in the early 2000s to treat women’s incontinence. It hit the market in 2003 and consisted of “a nonwoven polypropylene mesh that was threaded underneath the uretha, through the vagina, and out through the obturator foramen,” according to the American Journal of Obstetrics & Gynecology.
Like the ProteGen Sling, ObTape was cleared for sale by the FDA “without clinical proof of its safety and efﬁcacy,” according to the American Journal of Obstetrics & Gynecology. It, too, caused patients immeasurable harm. As a result, Mentor discontinued it in 2006.
Many Brands Have Never Been the Subject of a Vaginal Mesh Recall
Many brands of surgical mesh are still being used to treat women. Doctors are still using the Avaulta System, for example, and the Johnson & Johnson surgical mesh product known as the Gynecare TVT is still being used, despite the fact that it was approved by the FDA based on its similarity to Boston Scientific’s ProteGen Sling, which has since been recalled.
Victims of Many Mesh Brands Are Suing
Victims of surgical mesh injuries have filed lawsuits to obtain compensation for their injuries. Those victims include patients who have received implants that have been subject to vaginal mesh recalls, and patients who have received implants that are still on the market—but nevertheless cause problems for those who have them.
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