Study Finds Use of Transvaginal Mesh Dropped after FDA Safety Alert
A study that appeared in JAMA Internal Medicine showed that the most recent safety alert issued by the U.S. Food and Drug Administration (FDA) with regard to the side effects of transvaginal mesh implants resulted in a drop in surgical mesh use. The FDA first looked at the use of surgical mesh in New York between 2008 and 2011 and found that use actually increased after the after the agency’s first safety communication – from 21 percent of all procedures in 2008 to 30 percent in 2011.
However, the use of vaginal mesh devices fell after a second, more severe alert issued by the FDA – from 30 percent in 2011 to 23 percent in 2013. Researchers say the difference in use patterns can be explained by the use of “stronger language” in the second warning, which was issued in 2011. But between 2008 and the end of 2010, the FDA received nearly 3,000 reports of complications associated with the use of transvaginal mesh to treat problems such as pelvic organ prolapse and stress urinary incontinence.
In 2011, the agency made it clear that complications do occur as a result of these procedures and said vaginal mesh devices may not be the most effective cure for pelvic organ prolapse. The agency also ordered dozens of surgical mesh manufacturers to conduct post-market studies to address concerns over the device’s safety and effectiveness.
Vaginal Mesh Side Effects
A number of women have reported nightmarish side effects as a result of using transvaginal mesh devices. Thousands of women have reported side effects including mesh erosion, chronic pain, difficulty sitting down, nerve damage, pieces of the device getting embedded in the vaginal wall and pain while having sexual intercourse.
These are severe and painful side effects, which have destroyed lives. A number of mesh manufacturers are facing product liability lawsuits nationwide from women who say that the conditions for which they got the device implanted got worse, and that they could not get pieces of the mesh removed from their bodies despite several surgeries.
These patients not only incurred significant medical expenses, but also experienced significant emotional trauma as a result of being unable to work, earn a livelihood and being unable to even have intimacy with their partners. As product liability attorneys representing women who have been harmed by these dangerous and defective medical devices, we believe there is much work to be done by the FDA and manufacturers when it comes to ensuring that the products put in the market are properly tested and safe for consumers to use.