Yesterday, the FDA announced that Essure, a popular sterilization implant, could have serious side effects and ordered Bayer to conduct new safety trials on the device. In addition, the FDA drafted a “black box” warning for Essure’s label, a measure that is reserved for drugs with “life-threatening risks.”
Essure, which has been on the market since 2002, has long been touted as a safe and noninvasive alternative to tubal ligation. Rather than full surgery, Essure is a small coil designed to be inserted into the fallopian tubes. The idea, according to Bayer, is that scar tissue builds around the coil and forms a “natural barrier over time,” which prevents sperm from reaching an egg. And the device has been relatively popular since its introduction; it’s estimated that 750,000 women have the device.
But despite Essure’s popularity, a large number of women claim that the implant has caused a range of side effects. NPR reports that one patient experienced everything from:
Chronic fatigue, migraines, joint pain, digestive issues, back pain, heavy periods full of clots, difficulty concentrating, abdominal pain, hair loss, tooth deterioration, depression and such severe bloating she sometimes refused to go out in public because she feared being asked if she was pregnant.
And that patient certainly wasn’t alone; thousands of women organized online, outlining symptoms including pregnancy. Groups like Essure Problems have thousands of members who have detailed eerily similar health problems.
The self-named E-sisters have spent the last few years warning of Essure’s side effects, as well as lobbying Congress and the FDA to take the drug off the market. Buzzfeed reports:
Angie Firmalino, the group’s founder, told BuzzFeed News she had to have a hysterectomy and multiple painful procedures after the coils were expelled from her fallopian tubes. Women who get Essure are about 10 times more likely to need follow-up surgeries than those who get their tubes tied, according to one study.
Despite the proliferation of women who claim complications from Essure, the data has been a bit murky. Original safety trials demonstrated to the FDA that Essure was safe, but Buzzfeed notes that women with failed implants were removed from those studies, creating a much rosier picture of the device. Furthermore, Essure’s safety trials didn’t include comparison control to traditional methods like tubal ligation, so there’s no evidence that the device is safer than what was already available, just ostensibly less invasive.
Then there’s the broader problem with feedback on birth control: namely, that many women tend to associate non-related problems with their birth control method. NPR reports:
According to Elizabeth Micks, an OB-GYN and contraception specialist at the University of Washington Medical Center in Seattle, women commonly complain about various concerns that they attribute to their method of birth control, even if their method cannot feasibly cause some of those complaints.
“Some are valid, and some may not be valid, and it’s hard to really know in some cases whether the method is causing the patient’s complaints,” Micks said. “I think it is very clear that some women have been harmed by the Essure device.”
But as Buzzfeed points out, one of the biggest problems with Essure is that “there is no official protocol from Bayer on how doctors can remove the coils.” So if something went awry, doctors resorted to hysterectomies or simply removing fallopian tube altogether.
While the FDA’s decision was relatively stern and requires Bayer to conduct a new study, E-sisters said that were “outraged” by the agency’s decision to leave Essure on the market. “We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device,” the group Essure Problems said in a statement.
But the FDA believes that benefits of Essure continue to outweigh the risks. “The agency has carefully reviewed all the available evidence ... While there are risks associated with the use of Essure, there are also benefits,” William Maisel, chief scientist at FDA’s Center for Devices and Radiological Health, told the Washington Post. “We believe informed women should have this as an option available to them.”
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Image via AP.