FDA decision leaves many upset that device is still available.
Despite thousands of women with complaints about the German drug maker Bayer AG’s permanent birth control device Essure, the United States Food and Drug Administration has decided to leave the device available in America, but with a new type of warning box about the possible side effects of its use.
According to an article in the Washington Post, the agency will require the placing of a “black box” label containing a warning about the side effects, and will provide a checklist for doctors to discuss with their patients about the risks associated with the device. The agency also said it will require Bayer AG to provide new safety studies to the FDA.
William Maisel, chief scientist at FDA’s Center for Devices and Radiological Health agreed there are risks involved, but there are also benefits and the agency believes women should have the device as an option available to them.
Reports from women that have used the device detail health issues, including pelvic pain, stomach swelling, dizziness, cramping, bleeding and fatigue, and many of those women have taken to social media to express their concerns and ask to have the device removed from the marketplace. A group on Facebook, called Essure Problems, said they were “outraged” by the decision of the FDA.
Capitol Hill also has a number of legislators that did not agree with the agency’s position. Rep. Rosa DeLauro (D-Conn.) said the follow-up safety studies should be done, but the device should not be available until the studies were completed. Rep. Mike Fitzpatrick (R-Pa.) said it was “unbelievable” that it took the FDA from September to make the recommendations with no enforcement measures, and leave the device on the market. Rep. Fitzpatrick has previously called for the FDA to halt the sale of the device.
Bayer AG has maintained the device has a solid safety record and they believe it should remain on the market as an alternative for women’s birth control. The company said it will continue to work with the FDA, which initially approved the device for use back in 2002.
Dario Mirski, senior vice president and head of medical affairs Americas at Bayer released a statement saying, “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.”
The FDA says it will seek public comments in the new recommendations for the next 60 days.