FDA puts restrictions, but no recall, on birth control implant
FDA puts restrictions, but no recall, on birth control implant
FDA Restricts Sales of Bayer's Essure Contraceptive Implant
11 April, 2018, 12:35
The following statement: "The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer".
Separately on Monday, Germany-based Bayer said Essure's benefit or risk profile had not changed and that the company remains positive about the product.
The FDA says the order was made after the administration discovered some women were not being adequately informed of Essure's risk before getting the device implanted. Although Essure sales have decreased by ~70%, the FDA believes that some women are still not being informed about the established risks of Essure prior to implantation.
The patient brochure, titled in part "Patient-Doctor Discussion Checklist" must now be reviewed with a doctor. "Every single woman receiving this device should fully understand the associated risk".
The FDA on Monday announced strict new requirements on the controversial Essure sterilization device, which already comes with a "black box warning", the strongest warning label the agency can require. Patients must be allowed the opportunity to sign the acknowledgment and it must also be signed by the physician implanting the device. "It does look like it's going to restrict Bayer's sales until they are in compliance".
Essure, approved by US regulators in 2002, is a non-surgical and non-hormonal permanent birth control device.
As the manufacturer, Bayer must ensure that providers comply with the new restrictions, the FDA said.
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. The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.
Essure, approved in 2002, is an alternative to surgical sterilization. US regulators found that some doctors weren't always telling women about the Bayer's device's risks, which can include bleeding, pain and organ perforation.
The warning label was added to the device in 2016 after thousands of adverse event reports were submitted to the FDA describing issues such as persistent pain, perforation of the uterus or fallopian tubes, abnormal bleeding, allergic reactions, and unplanned or ectopic pregnancies.
In a statement after the announcement, Bayer said it will continue to tell health care providers about "the importance of appropriately counseling each patient on the benefits and risks of Essure".
In the 16 years since approval, the FDA said it has received more than 26,000 reports of adverse events - nearly 12,000 last year alone - including miscarriages, fetal deaths, and other problems.
In February, the FDA and Bayer cited a new study that showed Essure is generally safe. The agency noted that most of the new reports came from attorneys representing patients suing Bayer.
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