ibusinesslines.com August 20, 2018

Bayer Will Soon Stop Selling Essure Birth Control Devices

24 July 2018, 01:16 | Melissa Porter

Bayer to Stop Selling Essure in U.S.

Bayer to phase out Essure birth control device in U.S

Based on that investigation, the FDA issued a black-box warning-the agency's most serious kind of warning-and ordered Bayer to conduct a post-market study to evaluate the safety of Essure.

In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits. Using a scope device that enters the uterus through the vagina, a doctor implants one coil in each of the openings of a woman's fallopian tubes (see the diagram at the bottom of this post).

In May, the FDA said doctors must show women a checklist of the device's risks before implanting it.

In their press statement, Bayer notes that the "increased reliance on other birth control options, such as long-acting reversible contraceptives, and inaccurate and misleading publicity about the device" is what contributed to the decline in interest for Essure.

In a statement, Bayer attributed the decision to a "decline in us sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable".

Dr. Yesmean Wahdan, an obstetrician/gynecologist at Bayer US Medical Affairs, Women's Healthcare, said in a video statement Friday that the company "made a business decision to discontinue sales and distribution because of a decline in sales".

The device was developed by Conceptus Inc. and acquired by Bayer in 2013.

Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we'll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure. The company said it continues to "stand behind the product's safety and efficacy". A self-described "data advocate", she analyzed public data on Essure and presented her findings to hospitals, patients and attorneys to help argue against the product.

On Tuesday, Firmalino and other Essure activists held a daylong protest outside Bayer's US headquarters in Whippany, N.J. As part of it, they broadcast a clip from the forthcoming Netflix documentary about medical device failures called The Bleeding Edge.

The FDA has received 27,000 reports of injuries related to Essure implants in the past 16 years. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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