FDA ISSUES SECOND WARNING ABOUT COMPLICATIONS ASSOCIATED WITH TRANSVAGINAL MESH DEVICES

As women age, they sometimes suffer from a condition called pelvic organ prolapse (“POP”). Some doctors have treated this condition with a medical device called a surgical mesh. These surgical mesh devices – made from the same material as Rubbermaid storage containers – have never been tested on patients. Unfortunately, these untested devices have been found to erode patients’ insides, which can result in constant pain and additional operations.

The FDA first issued a warning about this device in 2008. However, as a result of a growing number of complaints of surgical-mesh complications in women, the FDA recently issued a second warning about the device. On July 13, 2011, the FDA issued an updated warning “to inform you that that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” This is a change from what the FDA previously reported in 2008. Moreover, the FDA stated that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in patients with POP and it may expose patients to greater risk.” The FDA will convene a panel of experts in September to advise whether surgical mesh should undergo more testing.

In the meantime, the FDA recommends that healthcare providers recognize that in most cases, POP can be treated without a mesh, thus avoiding the risk of mesh-related complications.

If you or someone you know has suffered serious complications and additional surgery as a result of a transvaginal mesh or sling medical device, please contact Pogust Braslow & Millrood. Just fill out this form, click here to send us an email or call us at (610) 941-4204.