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On Monday, the FDA now advises that Essure birth control implant devices made by Bayer should carry the strongest safety warning label – the black box – that warns of serious health risks. This comes after thousands of women in have contacted U.S. regulators with complaints about the device.
The U.S. Food and Drug Administration has also asked German-based drug maker, Bayer to do a post-market study of the Essure device.
Bayer acquired Essure in 2013, which has been available for sale in the U.S. since 2002. Since that time, there have been calls that it be completely withdrawn from the market due to the number of complaints received.
The FDA-required “black box” warning label will list possible risks to health such as perforation of the uterus and fallopian tubes and allergic reaction to the nickel that is used in the device’s construction. The agency is also asking the public to submit comments on the language to be included in the label warning.
Essure has been promoted as a more affordable alternative to women having a tubal ligation as a means of permanent birth control. The Essure device consists of two small nickel-titanium coils which are surgically inserted into the fallopian tubes. The scar tissue that forms around the device prevents pregnancy.
Women who have had Essure implanted have complained of the devices breaking as well as chronic pain, bleeding and other disorders such as lupus, psoriasis and allergies.
The FDA has also issued for doctors a checklist that should be discussed with patients concerning the potential risks connected to the device.
The agency does believe that Essure should remain available on the market and according to Dr. William Maisel, Deputy Director for Science at the FDA’s center for devices and radiological health, should be available to women who have been informed of the potential risks involved.
The post-market study will enroll more than 2,000 women who will be followed for a minimum of three years and will compare the Essure implant to tubal ligation, Maisel said.
It is estimated that some 750,000 women worldwide have had the Essure device implanted. Some 70 percent of these are in the United States.
When the FDA announcement regarding the Essure was made, members of the Facebook group, “Essure Problems” expressed disappointment. The Facebook group, along with Public Citizen, a consumer watchdog group, have asked that the Essure device be banned after more than 5,000 reports of adverse reactions were made to the FDA according to the agency’s website.
If you or a loved one has experienced adverse side effects after using Bayer’s Essure, give the offices of John Foy & Associates a call today. You may be entitled to a cash settlement for any expenses due to the use of Essure in a class action lawsuit. Such a settlement can help you pay medical costs to remove the device, lost wages from time off the job as well as pain and suffering. Call 404-400-4000 to schedule a consultation today.
