FDA restricts sale of Bayer's Essure birth control device

Sale of Essure contraceptive restricted; women must be told of risks

After noticing an increase in side effects, the FDA added new warnings for Essure in 2016, including a checklist that doctors were supposed to go through with patients.

Those risks include perforation of the uterus and/or fallopian tubes, persistent pain, allergic reactions, and "migration of inserts to the abdominal or pelvic cavity", which are "adverse events" the FDA said some women have experienced with Essure.

Now, the agency is using a "unique type of restriction" to make sure only providers and facilities that inform patients about the risks and benefits of the device may offer it. It comprises two metal coils that are inserted through the vagina and cervix into the fallopian tubes. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.

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Bayer's device, which is an alternative to sterilization surgeries, was first approved in 2002 and is the only product of its kind on the market. 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. Some women have reported headaches, fatigue, weight changes, hair loss, and mood changes (such as depression). It said the FDA "has repeatedly determined - after a rigorous review of the scientific evidence" that Essure "is a safe and effective medical device that benefits women by providing them with a valuable contraception option". The patient must be allowed the chance to sign the acknowledgment, and it must be signed by the physician implanting the device. The patient brochure must be reviewed with the prospective patient with their health care provider to ensure the patient understands the risks, benefits and other information about Essure implantation.

The FDA is expecting Bayer to implement these new regulations immediately, stating they will review and monitor Bayer's plans to comply with the restrictions.

Still, one expert in women's health said the FDA move can only be helpful to women. If these procedures are not followed, the FDA said it will take criminal and civil penalties action.

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Because of the reported complaints, Bayer was ordered to conduct a 2,000-patient study in 2016.

However, numerous reports of adverse events, including procedural complications, need for second procedures, chronic pain, and device failure - i.e., patients became pregnant - prompted the agency to begin re-examining Essure in 2015. The agency is now monitoring the company's progress. Additionally, the FDA required a more comprehensive patient decision checklist to provide women considering Essure information about the benefits and risk of the device. The agency noted that most of the new reports came from attorneys representing patients suing Bayer. Although Bayer's post-market study now has demonstrated adequate progress, including tripling of the total number of enrolled patients over the past six months, the FDA plans to require Bayer to increase the number of participating study sites to account for the declining sales volume. US health officials are placing new restrictions on a contraceptive implant that has been subject to thousands of reports of painful complications from women.

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