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Sales of Essure birth control implant to be halted by Bayer; U.S. last to sell controversial device

(Courtesy of Bayer)

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.

Firmalino said she had the device inserted in 2009 and almost immediately began having pain and bleeding; she eventually learned that the coils had migrated to her uterus and had a hysterectomy. In 2011, she started the Facebook group “Essure Problems,” which has waged a social media campaign against the device and pressed the Food and Drug Administration to ban it. The group has 37,000 members.

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.

As reports of complications have mounted over the years, the FDA has consistently maintained, as Bayer has, that the device's benefits outweigh its risks. But the agency also has acknowledged that there have been serious problems associated with the contraceptive and ordered up additional warnings and safety studies.

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.

Earlier this year, patient advocates told Scott Gottlieb, the commissioner of the FDA, that many women still were not being adequately warned about the risks. In April, the agency imposed a unique restriction on the product: It limited sales to doctors who guaranteed that women were being told about the device's risks and said Bayer would be held responsible for implementing the requirement.

On Friday, in a statement, Gottlieb tried to reassure women who are using Essure without problems that they can continue to do so; those who think they are having symptoms caused by the device should talk to their doctors. "Device removal has its own risks," he added.

Some Essure opponents have long been critical of the FDA, saying it approved the device based on an inadequate study and should have moved more aggressively as safety concerns emerged.

"The FDA should have required a moratorium on sales and requested that new data be submitted in a much more timely fashion," said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank.

On Tuesday, women protesting Essure staged a protest outside Bayer's U.S. headquarters in Whippany, N.J. to show a Netflix documentary that features Essure and other medical devices. Called "The Bleeding Edge," the film is to be released next week.

One of the attendees was Tess Schulman, a 47-year-old paralegal from Raleigh, N.C., who got the device in 2009.

She said she soon developed "strange allergies," prompting her doctor eventually to conclude that  her problems were caused by the nickel in the coils. After having the device removed in 2015, she said, her fatigue and troublesome rashes quickly disappeared.

An estimated 750,000 devices have been sold, mostly in the United States.

Read more:

The battle over Essure, the controversial female contraceptive device.

FDA to require 'black box' warning, but leaves Essure implant on market 

FDA restricts sale of Essure, requires that women be informed of risks with device