Serious Complications from Transvaginal Mesh Are Not Rare
May 3rd, 2012 tmccoy
Transvaginal mesh is often used to treat pelvic organ prolapse or stress urinary incontinence, two problems which are particularly prevalent for and only occur in women. In the late 1990s, the FDA first cleared vaginal mesh because they found it to be substantially similarity to products already cleared for sale that are used to fix internal hernias. Even though transvaginal mesh used a different method of implantation (inserted through the vaginal wall, rather than with abdominal surgery) and for an entirely different part of the body than hernia mesh, these surgical mesh “kits” were marketed as the new and improved method to treat urinary incontinence. Those these kits were new, they ended up not being an improvement on the previous treatment methods.
In 1999, Boston Scientific recalled its surgical mesh product called the ProteGen Sling, after receiving countless complaints of pain, infections, and injuries such as erosion. More recently Johnson & Johnson has faced hundreds of lawsuits over a surgical mesh device that was substantially similar to and had actually had been cleared based on its similarity to the ProteGen Sling, a product which had been taken off the market over ten years before.
In 2008 the FDA made a pronouncement that surgical mesh complications were serious, but rare. Between 2008 and 2010, the complaints about transvaginal mesh grew into the many thousands. In July 2011, the FDA said that “serious complications with mesh are not rare” Finally, in January 2012 of this year, the FDA ordered mesh manufacturers to conduct studies of surgical mesh, studies which surely should have been done longer before the products were put onto the market.
Source – Scientific America
