Health Care

FDA restricts Essure birth control device sales

FDA restricts Essure birth control device sales”

The FDA announced their decision after learning that some women were still not being adequately informed of the risks associated with Essure before implantation despite efforts to educate doctors and patients about these risks. 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 new Essure labeling, which will now be legally required when this product is offered to a patient, restricts the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device.

The agency said Bayer, which manufactures the device, will be responsible for implementing the restrictions immediately and for ensuring that providers comply.

The FDA is mandating a unique type of restriction on the device to restrict the sale and distribution, imposing additional requirements needed to provide a reasonable assurance of its safety and effectiveness.

Bayer is facing a raft of lawsuits from patients who say they have experienced complications related to the product, including perforation of the uterus or fallopian tubes, persistent pain and allergic reactions.

USA sales of Essure have dropped approximately 70 percent since the agency ordered the company to conduct a post-market study, the FDA said in the statement. It plans to enforce these requirements and will take action for a failure to comply, including applicable criminal and civil penalties. That is simply unacceptable.

In February 2016, the FDA required Bayer to conduct a post-marketing study which resulted in the addition of a Boxed Warning and patient decision checklist to the labeling 7 months later. Women allege Bayer knew of the risks associated with Essure, but failed to warn sellers, doctors and regulators of the dangers. The agency indicated that Essure's role in these symptoms is now unknown.

"Ensuring informed decision making is just one important step in our ongoing efforts to monitor this device".

Agency officials said Monday that they would continue to evaluate new information about the device and "regulatory options" that balance risks and benefits.

Essure, which boomed in popularity when it first came on the market in 2002, has been billed as a convenient alternative to surgical sterilization, informally known as getting your tubes tied.

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. The agency is now monitoring the company's progress.

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. Bayer is deeply committed to providing women with safe and effective healthcare options that meet their individual needs, and is dedicated to ensuring the continued safe, effective and appropriate use of Essure as an important option for permanent contraception. The agency also mandated that a more extensive patient decision checklist be added to the product's labeling.



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