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Bayer To Pay $1.6B For Peddling Dangerous Device To Women

German pharma insists it has 'commitment to women’s health,' even after 39,000 American women say they were harmed

St. Louis Business Journal – Bayer has agreed to pay $1.6 billion to settle about 90% of the 39,000 legal claims in the U.S. over injuries women said were related to their use of the German pharmaceuticals company’s Essure birth control device.

The settlements include all of the jurisdictions with significant volumes of Essure cases. It also includes an allowance for outstanding claims.

The company said in announcing the settlement:

“With the settlements, Bayer resolves virtually all of the U.S. Essure litigation so that the company can focus on its commitment to women’s health, where it has long been a leader, without the distractions and uncertainties associated with this litigation.

“There is no admission of wrongdoing or liability by Bayer in the settlement agreements.”

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Bayer said in 2018 that it would end sales of the birth control product in the U.S., citing declining sales of the implantable device and not based on safety concerns … Read more. 

Essure

From Wikipedia, the free encyclopedia

Essure is a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. Essure was designed as an alternative to tubal ligation.

Although designed to remain in place for a lifetime, it was approved based on short-term safety studies. Of the 745 women with implants in the original premarket studies, 92% were followed up at one year, and 25% for two years, for safety outcomes.

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A 2009 review concluded that Essure appeared safe and effective based on short-term studies, that it was less invasive and could be cheaper than laparoscopic bilateral tubal ligation. About 750,000 women have received the device.

Initial trials found about 4% of people had tubal perforation, expulsion, or misplacement of the device at the time of the procedure.

Since 2013, the product has been controversial, with thousands of women repeating severe side effects leading to surgical extraction.

Rates of repeat surgery in the first year were ten times greater with Essure than with tubal ligation.

Campaigner Erin Brockovich has been hosting a website where women can share their stories after having the procedure.

As of 2015 many adverse events, including tubal perforations, intractable pain and bleeding leading to hysterectomies, possible device-related deaths, and hundreds of unintended pregnancies occurred, according to the US FDA adverse events database and other studies.

It was developed by Conceptus Inc. and approved for use in the United States in 2002.

Conceptus was acquired by Bayer AG of Germany in June 2013. In 2017, the CE marking in the European Union, and thus the commercial license for Essure was suspended for at least three months.

Authorities in France and Ukraine recalled the implants, and the manufacturer withdrew the product voluntarily in Canada, the UK, Finland, and the Netherlands.

In April 2018, the FDA restricted sale and use of Essure which resulted in a 70% decrease in sales.

In July 2018 Bayer announced the halt of sales in the U.S. by the end of 2018. The device is featured in the 2018 Netflix documentary, The Bleeding Edge.

A 2015 review found the effectiveness of Essure is unclear due to the low quality of evidence.

With perfect use another review found evidence of a 99.8% effective based on 5 years of follow-up.

The reported insertional failure rates are “failure to place 2 inserts in the first procedure (5%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)”.

Upon follow-up, occlusion was observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months.

A 2015 study published in the BMJ concluded that Essure was as efficacious as laparoscopic sterilization at preventing pregnancy, but with a “10-fold higher risk of undergoing re-operation” when compared to patients who underwent a laparoscopic sterilization procedure.

For the Essure method, three months after insertion a radiologist is supposed to perform a fluoroscopic procedure called a hysterosalpingogram, to confirm that the fallopian tubes are completely blocked and that the woman can rely on the Essure inserts for birth control.

A contrast agent (dye) is injected through the cervix, and an x-ray technologist takes photos of the Essure coils to ensure no contrast leaks past the Essure.

Serious side effects may include persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.

Because of the stainless steel medical staff need to be notified before an MRI can be done. However, the inserts were found to be safe with MRI using a 3-Tesla magnet and is considered MR-conditional.

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