For the second time, four Democratic lawmakers are seeking hearings into two controversial medical devices, the Lap-Band surgical weight loss device, made by Allergan Inc. and transvaginal meshes made by Johnson & Johnson.
In a letter sent last week, 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 at this time.
The group urged Republicans who control the House Energy and Commerce Committee to hold the hearing and demand documents from manufacturers, according to a report by Bloomberg. The request is needed as it comes at a time when Congress is considering a complete overhaul of FDA rules for medical devices, according to the Democratic lawmakers.
“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 the 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.”
Earlier this month, the FDA ordered J&J and 32 fellow manufacturers to conduct safety studies of the vaginal implants, citing reports of internal injuries. The representatives also said studies showed high rates of complications with the Lap-Band made by Allergan.
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.”
What are the 2 devices in question?
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 to the Democrats’ letter, in 2010, more than 30,000 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.
In the letter, the Democrats cited a study, published this week that found nearly half of patients with a gastric band had no weight loss or needed the device removed after six years. In addition, more than 40 percent had long-term medical issues.
A response to the letter may take some time as the letter said that Republicans still haven’t responded to an October request to hold a hearing on artificial hips and implanted brain stents that have also raised safety concerns.