Bayer halts sales of Essure sterilization implant outside of U.S.
November 30, 2017 - Uncategorized
Bayer will discontinue the marketing and sales of the sterilization device Essure in all countries outside of the United States, the company announced on Monday.
While a number of reports have linked the Essure implants to health problems, including chronic pain and bleeding, Bayer said it’s pulling the device from non-U.S. markets for commercial reasons.
“We would like to reassure the Essure patients and their accompanying healthcare professionals that this decision is made for commercial reasons and that it is not related to a safety or product quality issue,” the company said in a statement on its website.
Essure is a permanent birth control procedure that involves two nickel-titanium coils placed inside the fallopian tubes to spur the growth of scar tissue that eventually blocks the tubes to prevent pregnancy.
In 2016, the U.S. Food and Drug Administration added a boxed warning – its most serious type – to alert doctors and patients to problems reported with the implant.
While the label had already come with a warning of pelvic pain and bleeding immediately after the procedure, many women said the problems persisted and were so severe they needed surgery to remove the device.
Other women reported the implant had fallen out of position and embedded itself elsewhere in the body.
A Facebook group called Essure Problems where members share their stories and complaints with the device currently has more than 34,000 members.
In its statement, Bayer affirms that “Essure’s positive benefit-risk profile remains unchanged.”
“Essure’s safety and effectiveness remain supported by more than ten years of scientific research and real-life clinical experience,” the statement reads.
The company cites “an environment unfavorable to its prescription” as the cause of “a continuous decline in demand” for the last several months.
According to the FDA’s website, the agency continues to monitor the safety of Essure and believes that “the benefits of the device outweigh its risks.”
In an emailed statement, the agency said it is aware that Bayer is no longer marketing Essure in any countries except for the U.S.
“The FDA has taken several steps to ensure the ongoing evaluation of Essure’s safety and efficacy, as well as to educate healthcare professionals and women about the potential risks of using the device,” the agency said.