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Democratic Lawmakers Seek Hearings On Transvaginal Mesh, Lap-Band

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House Democratic lawmakers are seeking Congressional hearings on transvaginal mesh and Allergan Lap-Band medical device products. The group says the devices post hazards to patients.

Representative Henry Waxman (Democrat-California) and three fellow lawmakers have asked key Republicans in the House Energy and Commerce Committee to hold the hearing and order involved device makers to provide documentation, said Bloomberg News. The timing of the request is significant given that Congress is considering a U.S. Food and Drug Administration (FDA) overhaul of medical device rules, said Democratic lawmakers in a statement.

Earlier this month, the agency mandated Johnson & Johnson and 32 other device makers to conduct safety studies of vaginal implants following reports of internal injuries to patients, said Bloomberg. Also, the Democratic group pointed out that studies indicate increased complication rates for Allergan’s Lap-Band device.

“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,” Democrats said. “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,” they added.

Of particular concern, according to the letter, regarding the Lap-Band, is that “Even in the face of these serious medical complications, Allergan, the manufacturer of the Lap-Band, is seeking to expand the use of the device in children and young adults … despite concerns among some physicians that the procedure is too drastic or ‘extreme’ for a young person’s developing body.” The group also cited a recently published study that revealed that nearly half of all patients implanted with the gastric Lap-Band either experienced no weight loss needed to undergo device removal after six years, with 40 percent suffering long-term complications, noted Bloomberg.

NewsInferno recently wrote that Lap-Band gastric banding complications continue to rise, citing a study about potential issues years after the surgery. The surgery involves band placement around the top of the stomach, which creates a small pouch for food that makes patients feel full after eating smaller portions. Gastric banding is used when non-surgical weight loss methods have failed.

Transvaginal mesh is a surgical treatment for Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women, said NewsInferno. Thousands of women nationwide claim they’ve suffered and continue to suffer injuries because of defective transvaginal mesh devices. According to NewsInferno, transvaginal mesh has failed in one of several ways, typically eroding through the vaginal wall or skin, causing horrific pain; women complain of being unable to sit, stand, or lay in any position for more than a few minutes at a time. The FDA has received at least 1,500 reports in which a transvaginal mesh device failed to treat SUI or POP and, in the summer of 2011, the FDA issued a public safety notice about the growing number of incidents and the potential dangers of the devices, said NewsInferno.

“In 20I0 alone, nearly 300,000 synthetic vaginal meshes were implanted in American women. The most common complication associated with the device is erosion through the vagina, which can be potentially debilitating for some women and require multiple surgeries to correct. Even with multiple surgeries, some women are never able to recover from the damage,” the Democrats wrote. Meanwhile, according to the Democrats, said Bloomberg, Republicans continue to fail to respond to a request in October for a hearing on artificial hips and implanted brain stents that have also been linked to safety issues.

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