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Bayer has announced that after December 31, it will no longer distribute or sell the controversial Essure permanent birth control device in the United States. Essure, the only non-surgical permanent form of birth control for women marketed in the US, is inserted into the fallopian tubes, causing scar tissue to forms and create a barrier to block sperm from reaching and fertilizing a woman’s eggs.

Currently in the United States More than 16,000 women are suing Bayer over Essure. Worldwide there have been thousands of complaints regarding Essure and Bayer has already stopped Essure sales in Canada, Europe, South America, South Africa and the United Kingdom.

When Essure was first released original label warned that the device’s nickel could result in allergic reactions. Its current labeling lists hives, rash, swelling and itching as possible reactions. Since then thousands of complaints have been registered around the world regarding Essure and many women have attributed other problems to the implant, including mood disorders, weight gain, hair loss and headaches. At present in the United States the current FDA labeling for the device, with the qualifier: “It is unknown if these symptoms are related to Essure or other causes.”

This warning label came in March 2016, after six months of deliberation over the Essure complaints, the FDA ordered Bayer, to launch new clinical trials for the device. The agency also called for a boxed warning on packaging and for development of a “decision checklist” that patients would sign before receiving the device to show that they understand its potential risks. This directive came after more than 10,000 women formally complained to the agency of side effects after receiving the Essure implant. In May 2018 the FDA began requiring doctors to show women a checklist of the device’s risks before implanting it.

The timing of Essure’s discontinuation aligns almost perfectly with the release of a new Netflix film The Bleeding Edge. The documentary will be released on the streaming service on July 27, and it has been reported that the potential dangers of Essure are outlined in the film. The trailer for The Bleeding Edge does not specifically mention Essure, but does feature a woman claiming she developed a connective tissue disorder after “a medical device that broke” inside of her “started deteriorating [her] joints.” She does not mention the controversial birth control device but it is worth noting that in the last seconds of the trailer protesters are shown holding signs that call for Essure to be pulled from the market.

Bayer insists that the discontinuation of Essure sales was due to an overall decrease in sales and a growing reliance on other birth control methods. They did not mention the nearly 12,000 adverse incident reports made to the FDA in 2017 alone that were related to Essure, or the thousands of lawsuits currently filed against the company regarding the device. Bayer can no longer dodge their responsibility for producing this defective medical device and of failing to warn women of the risks associated with having it implanted.

At Saunders & Walker we have a long history of representing patients harmed by dangerous and defective drugs and medical devices.  Please do not hesitate to contact us for a free consultation.

 

 

 

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