![]() "People think pharma's got power," says the journalist Jim Spencer in the film. Michael Carome, director of the Public Citizen Health Research Group, amount to a $300 billion industry. Moreover, medical devices, according to Dr. The FDA, according to numerous insiders interviewed for The Bleeding Edge, maintains far looser standards for medical devices than it does for drugs, food or anything else that enters our bodies, in part because of some eyebrow-raising affiliations between the FDA and the very medical device manufacturers it purports to oversee. Some of these women have fought to get Essure taken off the market, with success throughout Europe, but it remains on the market in the U.S., where lobbying groups wield enormous power in Washington, particularly at the Food and Drug Administration, or FDA. Secondary subjects in the film report that they were instructed during Essure's clinical trials to indicate that they were "very satisfied" with the procedure merely because they had not gotten pregnant the bleeding and pain and tremors were seen as incidental. While complications like these are rare, and acknowledged by the manufacturers, they may not be as rare we we're led to believe. But the device can break and fragment, migrate into other parts of the reproductive system, and cause everything from autoimmune disease to neurologic disorders. The other three are all women who received the vaginal contraceptive Essure, from Bayer, which is supposed to trigger inflammation in the fallopian tubes, causing them to scar and seal shut, permanently. ![]() Removing it was described as being akin to getting bubblegum out of hair, or plying a crowbar out of concrete. One of the film's subjects, an orthopedic surgeon himself, received a hip replacement only to have it disintegrate inside his body and turn the surrounding tissue to pulp. Another is a 40-something mother who got a transvaginal mesh implant after experiencing urinary incontinence following the birth of her daughter the mesh melded with her organs and caused excruciating pain and abdominal bleeding.
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