The FDA announced that it is limiting the sale and distribution of the birth control device Essure, stating that not enough women are aware of the risk for adverse events linked to using the device.
The new Essure labeling restricts the sale and distribution of Essure to only healthcare providers and facilities that provide information to patients about the risks and benefits of the device.
"Patients deserve the most accurate and comprehensive information to help them make their health-care decisions, and Bayer has educated and continues to educate health-care providers about the importance of appropriately counseling each patient on the benefits and risks of Essure", the company said in a statement.
Almost 18 months ago, the FDA required Bayer to add a boxed warning to the product labeling stating information about adverse events linked to the device, "including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions".
In a statement, Bayer said it has worked with doctors to make sure that patients understand the product before it is implanted.
Bayer is required to implement the FDA's restrictions immediately. That is simply unacceptable.
The Essure contraceptive device works by creating an inflammatory response in the fallopian tubes, causing scar tissue to form that blocks the tubes.CreditBayer Healthcare Pharmaceuticals, Inc.
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Under Gottlieb, the health agency has been aggressive about expanding its reach, and the restrictions on Essure are the first time the FDA has threatened such penalties using its authority to regulate medical devices after they're on the market. "Every single woman receiving this device should fully understand the associated risk".
Some patients implanted with Essure experience adverse effects including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions.
Separately, Germany-based Bayer said on Monday that the benefit or risk profile of Essure had not changed and remained positive.
Additionally, women have reported headache, fatigue, weight changes, hair loss and mood changes like depression, however, it's unknown whether these are related to Essure.
To close this data gap, the FDA on Monday also ordered Bayer to submit an annual report with the number of devices sold and distributed.
In 2016, as a result of rising numbers of complaints about the device, the FDA directed Bayer to conduct a new safety study and to add a "black box" to the label, the strongest type of warning. The latest FDA action made such discussions mandatory.
The FDA said last month it had received almost 12,000 medical reports in 2017 related to Essure, with more than 90 percent mentioning issues around device removal. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.