For the second time, four Democratic lawmakers are seeking hearings into two controversial medical devices, transvaginal mesh products and the Lap-Band surgical weight loss device. The group, led by U.S. Representative Henry Waxman of California, asserts that both transvaginal mesh products and the Lap-Band devices are hazardous to patients, and that an investigation of their issues is vital as Congress considers an overhaul of Food and Drug Administration (FDA) rules for medical devices.
“The committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh,” Waxman and the other Democrats wrote in a letter sent last week to their three Republican colleagues who control the House Energy and Commerce Committee. “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.”
The letter is a follow up to an earlier one Waxman and colleagues wrote to the Republicans in October, seeking hearings on the same devices. So far, the Committee has not scheduled the requested hearings, and the four Democratic lawmakers state that they “remain concerned that the Committee’s previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation”
Transvaginal mesh devices are used in the surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). This past July, the FDA said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. According the Democrats’ letter, in 2010, more than 30,0000 U.S. women were implanted with transvaginal mesh products.
Transvaginal mesh devices were mostly approved through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing, based on the idea that the products were similar in design to a previously-approved device. However, the FDA is considering rescinding 510(k) approvals for transvaginal mesh devices used in POP repair, and has asked the makers of such devices to conduct safety studies of the products.
The “Lap-Band” is a type of gastric band device that is surgically implanted and wrapped around the upper portion of a patient’s stomach to reduce the size of the stomach, so that patients feel full more quickly, eat less and lose weight. According to Waxman’s letter, the FDA approved the “Lap-Band” device for obese patients, but has indicated that the device 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. According to the letter, a study 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. Several other studies raised similar concerns about effectiveness and complications.
“In December 2011, FDA issued warning letters to a marketing firm called 1-800-GET-THIN, LLC, and eight surgical centers in California that aggressively market the Lap-Band without adequately informing consumers of the risks associated with the device. According to a series of reports in the Los Angeles Times, the use of Lap-Bands by these surgical centers appears to have been associated with significant harm to the health of a number of Southern California patients, including the deaths of five patients since 2009,” the letter says.
Allergan, the maker of the Lap-Band device, is currently seeking FDA approval to market the device to 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.