April 11, 2018 Source: Usatoday 122
The Food and Drug Administration(FDA) moved Monday to put sales restrictions on a Bayer birth control implant that has been a target of consumer criticism.
The FDA said the Essure contraceptive device could only be sold to doctors who provide patients with detailed risk and benefits information. In order for Bayer to sell Essure to those healthcare providers, the providers must first agree to go through a comprehensive FDA-sanctioned brochure and checklist with patients.
"The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device," the agency said in a statement.
The FDA says it expects Bayer to submit a plan that will show how it tracks compliance.
"The FDA will review and monitor Bayer’s plan to ensure the company complies with the restriction," it says. It "will take appropriate action for a failure to comply, including applicable criminal and civil penalties."
The restrictions aren't due to any new safety finding or concerns, says Edio Zampaglione, Bayer vice president of U.S. medical affairs, women’s healthcare and neurology.
The Essure device consists of flexible coils that are inserted into the fallopian tubes. It is designed so the body then produces a scar tissue barrier that prevents sperm from fertilizing an egg.
The FDA approved the birth control method in November 2002. At the time, it was made and marketed by Conceptus, a company Bayer acquired in 2013.
In 2016, the FDA required Bayer to create a patient checklist, as well as add the strongest warning possible to the device packaging. The FDA also ordered Bayer to conduct a study "to better evaluate the safety profile of this device when used in the real world."
That study is now ongoing.
The FDA says it has received thousands of complaints about the device. Those grievances include abdominal pain, menstrual irregularities, headaches, fatigue and weight fluctuations. People also complained about dislodged or dislocated devices and device breakage.
Many people took to social media to complain about the Essure — and vocal consumer advocate Erin Brockovichhas spoken out against it.
Advocacy group Essure Problems put out a statement Monday saying its administrators, "along with over 36,000 members of their online support group, were excited to read today's FDA announcement restricting the sale and distribution of Essure in the United States."
Worldwide, more than 750,000 devices have been sold since Essure was first approved, says Bayer Spokesomean Courtney Mallon.
Mallon said the company is "experiencing a decline in sales due to the broad dissemination of misleading and inaccurate information on social media that is influencing women’s choices."
The FDA said U.S. Essure sales have declined about 70% since its 2016 mandates.
Bayer said in a statement that "the benefit/risk profile of Essure has not changed and remains positive."
"Choosing a birth control method is a very important and personal decision," the company said. Bayer "is dedicated to ensuring the continued safe, effective and appropriate use of Essure as an important option for permanent contraception."
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