Bayer halts Essure sales, women rally for right to sue

RICHMOND, Va. (WRIC) — The controversial birth control device Essure has been removed from the market in every country except the United States.

Bayer, the manufacturer of Essure, has announced it’s halting sales of Essure in all countries outside of the U.S. In a statement, Bayer told 8News it’s due to a lack of interest in the product outside of the U.S.

“Bayer made a commercial decision this Spring to discontinue the distribution of Essure® outside of the U.S. where there is not as much patient interest in permanent birth control,” the statement read.

The move also comes after the European Union suspended sales of the device. The suspension was prompted by the National Standards Authority of Ireland declining to renew Essure’s CE marketing. “CE,” according to the European

Commission website signifies products sold in the EEA that has been assessed to meet “high safety, health, and environmental protection requirements.”

In February 2017, Anvisa, the regulatory agency of Brazil temporarily banned sales of the device, citing product safety concerns. Brazil lifted the ban after

Bayer presented documents detailing test results that had been sought by Anvisa.

“I don’t want to see anybody else go through this,” says Shannon Walsh who had health complications from using the device.

Walsh is just one of dozens of women rallying on Capitol Hill Monday. She and the others claim Essure, a permanent birth control device, left them in permanent pain.

“We need Congress to restore our rights,” the women chanted in support of the Medical Device Safety Act of 2017.

Angie Firmalino, who founded a Facebook group devoted to Essure problems described the bill.

“It will allow people that are injured by class three devices to have their day in court,” Firmalino said. The group has more than 35,000 members.

Essure, which consists of two nickel coils placed into the fallopian tubes to block pregnancy is one of 157 class-3 medical devices, like breast implants, with federal preemption protection. This means its pre-market approval from the Food and Drug Administration (FDA) makes it difficult for anyone like Walsh who claims they have been harmed by the device to sue the manufacturer.

“This has been an absolute failure on the part of the FDA to monitor these devices,” Walsh said.

When 8News first met Walsh in February, she told us she has suffered from a constant rash, pain and brain fog so severe it cost her her job with the FBI, all of which started when she began using Essure. At the time, she had just had surgery to remove the device.

“I am so grateful I am alive,” she told 8News in that February interview.

Her story is like so many others who tell us the side effects of Essure have left them with life-altering pain.

“I had sharp stabbing pain begin on my right side,” says Khristi Gurganus, a Yorktown resident who has now had Essure removed.

The complaints range from abdominal pain to hives to hair loss to the device migrating and breaking apart in the body.

“Unfortunately, in the last six months I have passed particles or pieces of Essure,” said Lacy Bradley a Mechanicsville mom who has struggled with Essure.

When 8News first began looking into complications with Essure, the FDA had received 4,000 complaints ranging from severe cramping to pregnancy to even death. Today, 8News has learned those complaints to the FDA have soared to nearly 15,000. You can find more on the adverse event reports.

The FDA says it has taken several steps in the ongoing evaluation of Essure, telling 8News in a statement:

“The FDA is aware that Bayer is no longer marketing Essure in any countries except for the U.S. The company has informed us that they remain committed to fulfilling the obligations outlined in the 522 order for a postmarket study that the FDA issued last year. The FDA has taken several steps to ensure the ongoing evaluation of Essure’s safety and efficacy, as well as to educate healthcare professionals and women about the potential risks of using the device.”

The statement continues:

“After a careful review of available information, the FDA last year approved required changes to the Essure labeling, including a boxed warning and a Patient Decision Checklist to help better ensure women receive and understand information regarding the benefits and risks of this type of device. The FDA’s latest recommendations on Essure remain in place. The FDA strongly encourages health care providers to use the Patient Decision Checklist in discussions with patients considering Essure. The FDA is working with professional medical societies, patient advocacy groups and women’s health organizations to ensure that risk information about these devices is disseminated to patients considering Essure or other sterilization options.”

Meanwhile, Bayer stands behind the birth control device, telling 8News in a statement:

“Bayer stands behind the positive benefit-risk profile of Essure®, the only FDA-approved non-incisional option available to women for permanent birth control. The safety and efficacy of Essure is supported by more than a decade of science and real-world clinical experience. After extensive review, based on its regulatory standards, the Food and Drug Administration (FDA) states on its website that it ‘continues to believe that the benefits of the device outweigh its risks, and that Essure’s updated labeling helps to assure that women are appropriately informed of the risks.’”

“In addition, recent independent expert reviews of Essure® carried out by a number of health authorities, safety assessment bodies and medical organizations have each addressed the safety of Essure in detail and have each concluded that the benefits of Essure outweigh its risks.”  

But the woman rallying on Capitol Hill Monday say they are not giving up their fight against Essure.

“We are not going away,” Walsh said. “We want it taken off the market.”

Bayer is required to do a post-market surveillance study of Essure following the complaints. Bayer tells us 100 patients are enrolled in the study but a final report won’t come until 2023. Bayer also tells 8News there continues to be demand for Essure here in the United States.

This is a developing story. Stay with 8News online and on air for the latest updates.

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