The US Food and Drug Administration (FDA) has restricted the sale and distribution of Bayer’s birth control device, Essure, over adequate risk information and has imposed additional requirements in order to assure its safety and efficacy.
Previously, the regulatory agency ordered a post-market study and asked Bayer to include a boxed warning and a patient decision checklist on the labelling of the permanent contraception device.
It was found that, despite these efforts, certain women were not receiving adequate information regarding the risks associated with the implantation of Essure.
Essure is the only permanently implanted birth control device for women that does not require a surgical incision. The implantation requires a health care provider to insert flexible coils through the vagina and cervix and into the fallopian tubes. Over a three month period, scar tissue builds up around the inserts and creates a barrier that prevents conception.
Some of the adverse effects experienced by patients with Essure include perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic reactions. Women have also reported symptoms of headaches, fatigue, weight changes, hair loss and depression. It is unknown whether these symptoms are directly related to the device.
FDA Commissioner Scott Gottlieb said: “We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option.”
Under the new labelling, the device will be available only to health care providers and facilities that will inform about the risks and benefits to patients. The providers will be required to review a specific brochure with the patient, who has to sign an acknowledgement before implantation.
The FDA ordered Bayer to implement the restrictions with immediate effect and is set to review and monitor the company’s plan in order to ensure compliance, failure of which may lead to criminal and civil penalties.
Bayer said that the benefit/risk profile of the device has not changed and the new label will help in providing accurate and comprehensive information to patients.
A statement from the company read: “Bayer has educated and continues to educate healthcare providers about the importance of appropriately counselling each patient on the benefits and risks of Essure. The FDA requested we update the label to emphasise this point.”