Bayer is fighting back against accusations that emerged about its controversial birth control device Essure in a Netflix documentary highlighting the devastating complications of many FDA-approved medical devices.
The documentary, The Bleeding Edge, premiered July 27. It explores personal stories of patients and medical professionals who have suffered severe complications from the devices, examines the $400 billion medical device industry and questions the FDA's approval process. Much of the film centers on Bayer's Essure, a nonincisional contraceptive approved by the FDA in 2002. The birth control is inserted into a woman's fallopian tubes and produces scar tissue that blocks sperm from fertilizing her eggs.
In a statement released July 27, Bayer said the documentary lacks scientific support and cherry-picked facts to inaccurately portray the safety of Essure. It refuted the film's claim that medical device manufacturers and the FDA placed profits before patient safety.
According to Bayer the film ignores "the full body of scientific evidence that supports the FDA determination that Essure's benefits outweigh its risks" and disregards "the appropriate warnings that accompany the device."
The FDA restricted the sale and distribution of Essure April 9 to ensure women are well-informed before choosing this contraceptive.
Citing a decline in sales, Bayer announced July 20 it would stop selling its permanent birth control implant in the U.S. on Dec. 31.
Bayer faces thousands of lawsuits related to Essure from women who claim the implants caused severe complications resulting in hysterectomies, hair loss, unwanted pregnancies and abnormal uterine bleeding.