Lawmakers Call for Transvaginal Mesh, Lap Band Safety Hearings

Democratic lawmakers are calling for congressional hearings on medical device safety in the United States, highlighting recent problems with transvaginal mesh products and Lap-Band weight loss implants. 

Congressman Henry Waxman (D-CA) and other House Democrats have urged Republicans in control of the House Energy and Commerce Committee to hold a hearing over growing concerns that FDA approved medical devices are causing individuals throughout the country to suffer debilitating and potentially life-threatening complications.

The lawmakers want congress to look into the activities of the manufacturers, seek records regarding the safety record and design of the devices, and called for hearings in a January 20 letter (PDF) to their Republican colleagues.

The Lap-Band, or laparoscopic adjustable gastric banding, is a band placed around the upper part of the stomach that creates a small pouch which quickly fills with food. The band causes the person to feel full quickly, which may result in weight loss. However, the Lap-Band is linked to a number of complications, including erosion of the band through the stomach wall, the band moving out of position, nausea, vomiting, difficulty swallowing, gastroesophageal reflux disease (GERD), abdominal pain, and leaking of the gastric band. In addition, recipients must change their eating habits, as they are unable to eat large meals and must eat a series of smaller meals throughout the day for the rest of their lives or until they have the band removed.

Recent studies found that 40% of patients who were implanted with Allergan’s Lap-Band weight loss device suffered serious complications. In addition, the FDA raised concerns in December that many clinics were not fully disclosing the risks associated with Lap-Band procedures in advertisements.

Earlier this month, the FDA also called for more studies into the safety of vaginal mesh products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women, following growing reports of problems, and the agency’s own analysis which brought into question whether they provide any health benefits.

The Democrats point out that the vaginal mesh products were approved through the FDA’s controversial 510(k) process, which only required that the devices be substantially equivalent to products already on the market. That means they were not required to provide extensive clinical studies before doctors began inserting them into U.S. women.

The FDA is now requiring 99 new postmarket studies, with 88 of those focused on surgical mesh for pelvic organ prolapse and 11 targeting single-incision mini-slings used to treat stress urinary incontinence. Manufacturers will have to submit study plans to the FDA showing how the studies will address the agency’s safety concerns.

An estimated 300,000 synthetic transvaginal meshes were implanted in women in the U.S. in 2010.

Last summer, the FDA issued a warning about the risks of problems when vaginal mesh products are used, especially for repair of pelvic organ prolapse. The federal health regulatory agency indicated that it could find no benefit in using transvaginal mesh to treat POP when compared to older, safer alternatives.

Between 2008 and 2010, the FDA received more than 1,500 reports of transvaginal mesh complications, including erosion of the mesh into the vagina, contraction or shrinkage of the mesh, infections, pelvic pain, urinary problems, vaginal scarring and other complications.

A growing number of transvaginal mesh lawsuits have been filed in courts across the country by women who say that vaginal sling manufacturers created defective products and failed to warn doctors or patients adequately about the risk of complications.

Democratic lawmakers sent a similar letter to Committee Chair Fred Upton and other Republicans on the committee in October to ask for a hearing on brain stents and metal-on-metal hip implants, but Republicans have refused to respond.