U.S. Rep. Harry Waxman of California and three other Democrats on the House Energy and Commerce Committee have asked the Republican who control the committee to hold hearings on the safety of transvaginal mesh, as well as Allergan’s Lap-Band surgical weight loss device. The four Democratic lawmakers are making the request for the second time since last October, after Republicans failed to schedule any hearings on the safety of transvaginal mesh products and the Lap-Band device.
“The committee should hold hearings to examine whether FDA (Food & Drug Administration) device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh,” Waxman and his colleagues wrote in their latest letter. “We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.”
According to Waxman’s letter the FDA approved the “Lap-Band” device for obese patients. It is designed to reduce the size of the stomach and cause patients to eat less and lose weight. Allergan is seeking to have the FDA expand its approval for use in children as young as 14, despite concerns among some physicians that the procedure is too drastic or “extreme” for a young person’s developing body.
However, while the Lap-band is effective, the FDA says it can pose serious risks including erosion of the band through the stomach wall, stretching the esophagus, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea and vomiting. Several studies have also raised questions about its safety and effectiveness, including one published last week in the Archives of Surgery raised questions about the effectiveness of gastric banding, finding that after six years, nearly 50% of patients had either not lost weight or had needed the device to be removed and that over 40% of patients experienced long-term complications.
Transvaginal mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods. FDA staff has proposed that such devices be moved to the agency’s high -risk medical device category, which does not allow 510(k) clearances. Recently, the FDA ordered more than 30 manufacturers of transvaginal mesh products to conduct studies of their safety.
According to the Democrats’ letter, an investigation of the transvaginal mesh and Lap-Band issues is vital as Congress considers an overhaul of FDA rules for medical devices.