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 recall is Boston Scientific's ProteGen Sling.
Cleared for marketing by the 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 recall of the ProteGen Sling in 1999 after having received thousands of complaints.
Another mesh product, ObTape, was also taken off the market by its manufacturer. There was no recall of ObTape, strictly speaking, but its manufacturer, Mentor Corporation (a company that was eventually taken over by Johnson & Johnson), discontinued the product a few years ago.
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 before it was removed from shelves.
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.
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