The Food and Drug Administration (FDA) held hearings as part of its review of Bayer's birth control implant, Essure in September 2015.
The hearings came after thousands of complaints began pouring into the FDA about the device--a small coil implant. That's out of the 750,000 devices sold. After the 2015 hearings, an FDA website post promised an announcement by "the end of February 2016."
Today, that announcement came. An article from Reuters points to three actions:
- The FDA has instructed Bayer to conduct a clinical study about heightened risks for some women.
- It also and has issued draft guidance with labeling recommendations, including a "boxed warning label," the most restrictive type of warning.
- FDA published a checklist for doctors counseling patients on Essure
Bayer, a German company, offers Essure as an alternative to a woman having her tubes tied.
"Essure—the only permanent birth control with a nonsurgical procedure. Essure is over 99% effective at permanently preventing pregnancy," reads the Essure website.
Responding to the FDA announcement on Monday, Bayer issued a press release that included this statement, adding the company is working on the details of the mandate:
"Bayer will continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure."
Kim Hudak, who spoke at the 2015 hearings, was implanted with Essure in 2002, the same year it became available. Since that time, she said she's had constant infections, rashes and even minor neurological issues.
"Within 12 months of placement, I developed pain throughout my entire body," Hudak said
Several other women--mothers, students and even nurses--gave their testimony as well. Some of them discussed minor symptoms, like fatigue, while others addressed more serious issues, like the implant becoming dislodged, heavy bleeding.
Some said they were forced to undergo hysterectomies after the device made them ill. Hudak said she has a hysterectomy in 2013, which resolved most of her issues.
"For the properly counseled patient, for the patient who meets the criteria outlined in the instructions for use, Essure is a good product," a Bayer AG spokesperson said.
In the Bayer statement on Monday Dario Mirski, M.D., senior vice president and head of medical affairs Americas at Bayer said:
“Patient safety and appropriate use of Essure are our greatest priorities. A woman’s decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure.”
RELATED: Read the FDA hearing transcript (Sept. 2015)