Netflix’s documentary “The Bleeding Edge” is targeting a number of medical products and procedures, exposing how patients have been harmed by products they allege should never have been cleared by the U.S. Food and Drug Administration (FDA).
The show “reveals how the rush to innovate can lead to devastating consequences for patients,” according to its description. The series includes interviews with doctors and patients who allege they’ve been harmed by devices that should have been better vetted by the FDA, Time reported Friday.
The Netflix show targeted permanent birth control method Essure, among other procedures, for its failure to undergo adequate testing, allegedly causing subsequent harm to female users.
“Essure’s benefits outweigh any potential risks,” pharmaceutical company Bayer wrote in a Thursday press release, hitting back against the show’s allegations.
“Bayer is concerned about the ongoing public promotion of Essure removal, along with inaccurate or misleading information spread by third parties,” the press release also states. Bayer announced July 20 that Essure will no longer be available in the U.S. after Dec. 31. The company attributed the cease in production to a decline in sales.
Essure is a sterilization device inserted into a woman’s fallopian tubes to prevent pregnancy. The device produces scar tissue that blocks sperm from fertilizing the woman’s eggs. The procedure is permanent and generally can’t be reversed.
“There is no reliable scientific evidence to suggest that any new safety concerns exist with Essure,” Bayer maintained in its Thursday press release. (RELATED: ABORTION GROUPS CLAIM ABORTION PILL IS TOTALLY SAFE. GUESS THEY HAVEN’T SEEN THE FDA’S LATEST NUMBERS)
More than 16,000 lawsuits, however, have been filed against Bayer over Essure complications. Women cited hair loss, fetal death, hysterectomy, uterus and colon perforation, as well as severe pain and ectopic pregnancy among other complications. The FDA received 26,773 complaints about Essure between 2002 and 2017.
“It was simple … It was everything I was looking for,” Essure former spokeswoman and nurse who performed Essure testing during its clinical stages, Gaby Martinez, said in the Netflix documentary.
One woman who had the Essure procedure said she knew something was wrong when she left the doctor’s office and started cramping and bleeding more than she ever had. Another woman recounted how she’d experienced continual fevers and bleeding after the procedure and discovered upon a follow-up doctor’s visit that the device had traveled into her uterus.
“Even if the device was recalled because it was dangerous, you can still use it as a predicate and get your device cleared ’cause it’s substantially equivalent,” Dr. Rita Redberg, editor of JAMA International Medicine, said in the documentary, explaining how so many dangerous devices have been able to hit the market.
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