Mesh Medical Device News Desk, August 7, 2018 ~ The entertainment industry news source, Variety, reports on the controversy surrounding the documentary, The Bleeding Edge.
The Bleeding Edge, a documentary just released on Netflix, is being attacked by the companies it profiles.
Bayer, maker of the Essure birth control device, is criticizing the documentary as presenting an “inaccurate and misleading picture of Essure” that ignored scientific evidence. The German-based company says the benefits of Essure outweigh its risks.”
The company has set up a web page (here) to answer questions.
That may be, but Bayer has pulled Essure from the U.S. market. That move has the U.S. as the last country where Essure is no longer sold.
The company says the move is for financial reasons but Essure litigation is alive and well in the States as well, with 16,800 filing suit. The Facebook group, Essure Problems, has been a loud and vocal critic of Bayer and the product, which has hurt sales.
Essure is associated with serious risks including perforation of the uterus and fallopian tubes, bleeding, fatigue, hair loss, tooth decay, and even infant death.
The FDA reportedly received more than 16,000 adverse event reports about Essure.
The film recounts the lax regulation that device makers enjoy in the U.S. that allows essentially untested medical devices onto the market under the “least burdensome” standard – to manufacturers. It is called the 510(k) clearance process. After an exchange of paperwork, a device maker receives a clearance to market from the U.S. Food and Drug Administration.
It’s that lack of substantive safety checks that allows more than 90% of medical devices onto the market. Essure is slightly different in that it was class III, an FDA standard that connotes high risk, but its studies were short term – not long enough to assess the risk of a permanent implant.
“The Bleeding Edge “was produced by Amy Ziering and director Kirby Dick.
In a response to Variety, they say that “Bayer has a long history of maligning critics of Essure rather than addressing the harms it has caused to tens of thousands of women.” They said the record shows that the FDA’s expedited approval of Essure was based “only on two poorly constructed studies that weren’t randomized or non-blinded and that lacked comparator groups.”
The company has until the end of the year to take the device off the market. ###
Good Wx Post article on Essure