The Netflix film includes an examination of Bayer’s Essure birth-control device and its devastating effects on the lives of some women who received the implant. Last week, Bayer criticized “The Bleeding Edge” as presenting an “inaccurate and misleading picture of Essure” that ignored scientific evidence finding that “Essure’s benefits outweigh its risks.”
Bayer is pulling Essure from the U.S. market as of the end of 2018. It has cited, in part, publicity surrounding “The Bleeding Edge” for the decision. The company is facing extensive litigation related to Essure.
The team behind “The Bleeding Edge” defended the accuracy of their work this week. The filmmakers, led by producer Amy Ziering and director Kirby Dick, said in part 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.”
On Friday (Aug. 3), Bayer issued a response to the filmmakers’ statements.
“‘The Bleeding Edge’ producers’ comment that Essure trials ‘weren’t randomized or non-blinded’ and… ‘lacked comparator groups’ only further exposes their ignorance of the underlying science and the ethics involved in studying a medical device, like Essure, and demonstrates the deficiencies of their documentary,” Steven Immergut, VP, head of communications, pharmaceuticals for Bayer U.S., said in a statement sent late Friday to Variety.
According to Immergut, the suggestion that Essure should have been put through randomized clinical trials “completely ignores the ethical problems with creating a comparison group of women who were randomly subjected to invasive laparoscopic tubal ligation surgery, the only alternative permanent birth control for women.”
Moreover, according to Bayer, a blinded, randomized clinical trial requires that neither the patient nor the physician knows which treatment the patient is receiving. That “would clearly not be possible or ethical for a surgical procedure like laparoscopic tubal ligation or the permanent placement of Essure,” Immergut said. “These ethical concerns are among the reasons why FDA did not require such a trial for Essure.”
In Bayer’s first-quarter 2018 earnings report, the company said it had been served with U.S. lawsuits representing approximately 16,800 users of Essure as of April 13, 2018. The pharma giant said it anticipates additional lawsuits in the U.S.
“Plaintiffs allege personal injuries from the use of Essure, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages,” Bayer said in the Q1 report. The company also is being sued in Canada, having been served with two lawsuits over Essure that are seeking class-action certification.
Netflix has not directly weighed in on the controversy. According to a rep for “The Bleeding Edge” filmmakers, Netflix supports their statement.
In “The Bleeding Edge,” one Essure user who is profiled, Ana Fuentes, describes excruciating abdominal pain and chronic bleeding after she had the device implanted in 2011. Her medical complications eventually prevented her from working, and she was forced to place her four daughters in foster homes. This week, Fuentes set up a GoFundMe page to raise funds for living expenses and has received $5,830 in donations so far; according to Fuentes, she has found a place to live thanks to a homeless-assistance program and has been reunited with her children.
In its statement last week, Bayer said it “is reminding women with Essure that the safety profile of the device remains positive and unchanged.” Immergut called Essure “an innovative Class III medical device” that was approved under the FDA’s Premarket Approval (PMA) review, “the agency’s most rigorous pathway for medical devices.”
Bayer’s website for Essure currently has a prominent safety-information warning about the device:
“Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System of Permanent Birth Control during discussion of the benefits and risks of the device.
The pharmaceutical company’s 2,369-word “fact check” rebuttal about Netflix’s “The Bleeding Edge” is available at this link.
According to Germany-based Bayer AG’s 2017 annual report, the company’s expenses for “significant legal risks” amounted to €258 million ($299 million) last year, primarily for costs associated with litigation relating to four products: Essure, Xarelto (designed to treat and prevent blood clots), and antibiotic medications Cipro and Avelox.
In April 2018, Bayer entered into an agreement to pay $12.2 million to settle lawsuits filed by users of Mirena — an intrauterine system for long-term contraception — who had alleged the IUD resulted in perforation of the uterus. As of April 13, 2018, a total of approximately 4,100 cases would be included in the settlement, according to Bayer’s Q1 financial report. In addition, Bayer said, as of that date lawsuits from approximately 480 Mirena users alleging idiopathic intracranial hypertension from use of the IUD had been served on the company in the U.S.