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Sales of Essure birth control implant to be halted
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Oct

25

This is a re-post of an article, "Sales of Essure birth control implant to be halted by Bayer; U.S. last to sell controversial device" published by the Washington Post on July 20, 2018.  Written by Laurie McGinley

"Pharmaceutical giant Bayer said Friday that it will halt sales of its controversial Essure birth-control device in the United States at the end of the year, bringing to a close a protracted battle over an implant that thousands of women blame for serious health problems, including persistent pain and perforations of the uterus and fallopian tubes.

The company said Essure's removal from the market was "business decision" prompted by precipitous declines in sales in recent years. It said in a statement that it stands by the safety and effectiveness of the device, and added that women who currently have Essure in place can continue to “confidently” rely on it.

The United States is the last country where Essure is being sold. Last September, citing "commercial reasons,” Bayer announced it was ending sales outside the United States.

Essure, which is designed to cause sterilization, consists of two inch-long, flexible coils made in part from an alloy of nickel and titanium. In a procedure that takes about 10 minutes, a doctor inserts the coils through the vagina and cervix and into the fallopian tubes, which carry eggs from the ovaries to the uterus. Over three months, scar tissue is supposed to form around the coils, creating a barrier that keeps sperm from reaching the eggs.

In recent years, thousands of women have reported complications including autoimmune problems, unintended pregnancies and the migration of the coils into the pelvis or abdomen. Many said the problems were so severe that they had the devices surgically removed. Bayer has been served with lawsuits representing more than 16,000 patients, the company said earlier this year.

Angie Firmalino, one of the leaders of the fight against the device, on Friday said she was "blown away" by Bayer's announcement. "It took way too long, but we won," said the 46-year-old mail carrier from Tannersville, N.Y.

Bayer said Essure sales in the United States have plummeted by about 40 percent a year in recent years. On Friday, the company attributed the decrease to several factors: a decline in the number of women using permanent contraception; increased reliance on long-acting contraceptives that are reversible, such as intrauterine devices, and “inaccurate and misleading publicity” about the implant.

The device, which was approved by the FDA in 2002, was initially hailed as a nonsurgical alternative to tubal ligation, commonly called having one's “tubes tied.” It was developed by Conceptus Inc., a California medical products manufacturer that Bayer acquired in 2013.

In 2016, for example, the FDA required Bayer to add a “black box” — the agency's most serious warning — to the product's label. And it directed Bayer to create a three-page checklist for doctors to use in discussing potential problems with patients before implantation."

Finish reading the full article on WashingtonPost.com or find out if you have legal recourse against Essure. 

 

Class Actions & Consumer Rights, Essure

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