Pharmaceutical giant Bayer AG announced that it is halting sales of the dangerous Essure device after thousands of women suffered serious side effects ranging from persistent pain to organ perforation.
The Washington Post is reporting on the decision by Bayer to halt U.S. sales beginning in December, 2018, after threats from the FDA that the company would face civil and criminal charges if it did not fully inform patients of the serious health risks associated with the device.
Touted as an alternative to tubal ligation, Essure is a permanent sterilization device in the form of two coils made in part from an alloy of nickel and titanium that are inserted into the fallopian tubes. Over the course of three months, scar tissue forms around the coils and creates a barrier that prevents sperm from reaching the ovaries. The device soon proved problematic with women reporting problems of heavy bleeding, debilitating pain, ectopic pregnancy, allergic reactions to the alloy, organ damage when the device moved out of position, and even death. In 2017, nearly 12,000 Essure injuries were reported.
The FDA tried to manage the problem by placing a new black box warning on the device and required doctors to fill out a checklist to make sure patients understood the risks. But when injuries continued to mount, the agency imposed even stricter regulations, allowing only doctors and health care facilities that document discussing the risks with patients to implant the device.
In spite of this dire history, Bayer claims that the removal of Essure from the market was a “business decision” which was prompted by a decline in U.S. sales. They claimed sales dropped 40 percent in the last few years, a decline they blame on a decrease in the number of women seeking permanent contraception and “inaccurate and misleading publicity” about the implant.
However, the Arentz Law Group says the decision was made following threats from the FDA that the company would face civil and even criminal charges if it didn’t thoroughly inform patients about the implant’s serious health risks.
FDA Commissioner Scott Gottlieb insists that women who are currently using Essure can continue to do so without problems. He recommended that those who are having symptoms should speak with their doctors and to be aware that “device removal has its own risks.”
Women are not so sure. They have long been fed up with the Essure device and the way the FDA is handling their health and safety. In fact, just last week, Essure activists stormed Bayer’s U.S. headquarters in a massive protest, demanding that the company “stop turning a blind eye to the suffering the device continues to cause women the world over,” Arentz reports.
In the same week, a new Netflix documentary entitled, The Bleeding Edge, began to be screened. The movie details the destruction the device has caused in the lives of users.
Angie Firmalino, 46, one of the women who started the Essure Problems Facebook page, said she had the device implanted in 2009 and immediately began having pain and bleeding. She eventually learned that the coils migrated to her uterus and had to have a hysterectomy.
Firmalino told the Post that she was “blown away” by the news that Bayer was suspending U.S. sales.
“It took way too long, but we won.”
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