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Essure Faces Tighter Restrictions From FDA

When it was introduced in 2002, Essure seemed revolutionary: An implantable, permanent contraceptive device that would be available throughout the United States. It was an appealing long-term option that could replace hormonal birth control pills that had to be taken every day. But the hype around Essure might have been too good to be true.

Over the 15 years that Essure has been on the market, thousands of women have complained about serious–even dangerous–side effects. Recently, the Food and Drug Administration (FDA) announced that it would tighten its restrictions on the contraceptive device.

Serious side effects

This is how Essure is supposed to work: The device, which resembles a small, flexible coil, is inserted into a female patient’s fallopian tubes. Over several weeks, scar tissue builds up around the device, preventing sperm from fertilizing the woman’s eggs. Currently, it is the only non-surgical and permanent contraception available in the U.S.

However, the device does not always work as intended. Women have reported unintended pregnancies, miscarriages, stillbirths, bleeding, and severe pelvic pain. The FDA has received over 5,000 complaints about Essure, prompting it to restrict the drug’s sale and order Bayer, its manufacturer, to complete additional studies. Since Jan. 30, over 16,000 patients who were implanted with Essure have filed lawsuits against Bayer.

Victims have legal options

It is very troubling to think that unsuspecting patients may suffer dangerous side effects because of Essure. It is the responsibility of drug manufacturers to make sure that their products do not have serious risks, and it is health care providers’ responsibility to meet a high standard of care for their patients. If a company sells a faulty product or a doctor provides negligent care that results in injury, the results can be life-changing for patients.

Fortunately, victims do have legal recourse available. Product liability or medical malpractice lawsuits may be able to recoup the damages that a patient suffers, including lost income, medical bills, and emotional trauma.


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