Where there’s a will, there’s a way, and the “E-Sisters” have finally gotten theirs –Essure will be off the U.S. market by the end of 2018.
In July, Angie Firmalino, E-Sister and one of the leaders in the fight against Essure, told the Washington Post that she was “blown away” by the news. “It took way too long, but we won,” said the 46-year-old mail carrier from Tannersville, N.Y., who was implanted with the device in 2009. Ms. Firmalino started the Facebook group “Essure Problems,” In 2011 to give Essure victims the ability to communicate with others who have suffered harm. The Essure Problems group, which currently has more than 37,000 “E-Sisters,” has also been waging a social media war against Essure, urging the U.S. Food and Drug Administration to ban the permanent birth control device.
Initially approved by the FDA in 2002, Essure was at first hailed as a “nonsurgical alternative to tubal ligation” (having ones tubes tied). The premise behind Essure is relatively simple: a doctor inserts two tiny flexible metal coils through the vagina and cervix into the fallopian tubes during a 10-minute office procedure. Within three months, scar tissue will have formed around the coils, creating a barrier that prevents pregnancy at a rate in excess of 99%, according to U.S. Food and Drug Administration estimates.
But for thousands of women, including Ms. Firmalino, this once-promising device has caused some very serious problems – severe pain, bleeding, autoimmune issues, allergic reactions, unintended pregnancies, and perforation of the ovaries and fallopian tubes. After Ms. Firmalino was implanted with Essure, she almost immediately experienced pain and bleeding and upon learning that the coils had migrated to her uterus, underwent a hysterectomy.
From Essure’s 2002 approval through the end of 2017, the FDA received approximately 26,773 adverse reports related to the device. But in spite of this public outcry, the FDA stopped short of an Essure ban, instead issuing a series of warnings regarding the safety of the device:
-
February 2016 – The FDA announced that Essure would require a black box warning indicating extreme risks and potential serious injuries connected with use of the device.
-
September 2016 – The FDA ordered Bayer (the maker of Essure) to launch a postmarket surveillance study to obtain more information about the benefits and risk of Essure.
-
October 2016 – The FDA issued final guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization,” after reviewing feedback from a 2015 Advisory Committee meeting and public comments
-
April 2018 – The FDA restricted sales of the Essure device to only doctors and healthcare facilities that agreed to review the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” with patients. The FDA also approved new labeling regarding the risks and benefits of Essure.
By 2017, Bayer had voluntarily withdrawn Essure from the market in Finland, the Netherlands, the U.K., and Canada, and it has been banned in Australia and throughout Europe as well, making the U.S. the last country to permit sales of the hotly debated device. Finally in July 2018, Bayer released a statement outlining the company’s plans to remove Essure from the U.S. market by the end of the year. According to the statement, the move was prompted by declining sales, and Bayer made no mention of the 16,000 lawsuits pending in state and federal courts brought by patients claiming Essure complications so severe that they had to have the device surgically removed, a procedure that often involves additional risk.
“I have grave concerns that every women implanted with the device will ultimately be required to have it surgically removed, causing them additional pain and suffering and exposing them to additional risks,” said Kim Dougherty, who along with Erin Copeland and three other attorneys, make up the Plaintiffs’ Executive Committee of the California coordinated proceedings.
Both Ms. Dougherty and Ms. Copeland are skeptical regarding the motives behind Bayer’s decision to pull Essure off the market. “While Bayer claimed it was removing the product from the market as a ‘business decision,’ there can be no doubt that the FDA’s recent restriction on sales of the device and threats of penalties and fines had to have influenced that decision,” said Ms. Dougherty.
“I would like to think they came to their senses about the reality of this product being bad for women. But, in truth, it’s probably because they have lost significant profits due to the unpopularity of the device among patients and doctors,” added Ms. Copeland. “Too many women have been injured because of Essure and they are talking about it. Doctors are talking about it. This product is harmful. It is not at all what Bayer (or Conceptus, the product’s original manufacturer) have been representing since this product went to market. Bayer could no longer pull the wool over the public’s eyes,” she said.
The FDA estimates that 750,000 Essure devices have been sold globally, mostly in the U.S., and there is evidence that doctors continued to prescribe Essure to patients even after the serious health risks became known. Why would doctors continue to recommend a device that has come under tremendous scrutiny from the FDA and others for at least 10 years?
“It doesn’t hurt that physicians are reimbursed far more money to implant Essure than for performing a tubal ligation, and that it is far more convenient and takes much less time to implant Essure than booking an operating room and performing a tubal ligation,” said Ms. Dougherty. “Convenience and significant financial benefit are undoubtedly an influence in the continued recommendation of the device. Thousands of physicians also were receiving compensation from Bayer to promote the device.”
Netflix recently released the documentary “The Bleeding Edge,” a film that prominently features Essure and exposes the medical device industry’s penchant for putting profits before patients. A week before the film was released, Bayer abruptly announced that it would stop selling Essure, citing “inaccurate and misleading publicity about the device.”
But according to Ms. Copeland, “The Bleeding Edge” is extremely comprehensive and well worth watching. “I absolutely recommend people watch this documentary,” she said. “It provides insight into the lengths manufacturers, like Bayer, will go to get their products on the market and turn a profit at the risk of patient safety. They aren’t all heroes like they want the public to believe.”
Essure trials are expected to begin in California in the fall of 2019. While the outcome is unclear and Bayer continues to staunchly defend the device, Ms. Dougherty is hopeful. “It would be refreshing to see Bayer try to right this wrong, and not further victimize these women, and instead come to the table and attempt to resolve these cases and compensate these women for the terrible injuries that they have suffered,” she said. “But if they don’t, we are ready to bring them to trial and have a jury hold them accountable for all the suffering they have caused.”
