FDA panel recommends limited use of Bayer’s Essure until more is known about safety

An FDA advisory panel yesterday recommended that the agency limit the use of Bayer‘s (ETR:BAYN) Essure female sterilization device until more is known about its safety, after thousands of women reported serious health issues they attribute to the nickel-titanium implant.

Essure, the only approved permanent birth control device in the U.S., is a small metal coil that is placed in the fallopian tubes via catheter. The FDA approved the device in November 2002.

In the near 13 years since then, the health regulator said it had received 5,093 complaints, including those of pain or menstrual irregularities after using the device, as well as complaints of the device breaking. Those adverse event reports include 5 fetal deaths in women who became pregnant after using Essure and 4 adult deaths for reasons such as infection and uterine perforation, the FDA said.

In a report issued before yesterday’s meeting of the FDA’s Obstetrics and Gynecology Devices advisory panel, the agency said it logged a nearly 1,400% spike in complaints filed over Essure in the last 3 years. Yesterday a Bayer’s director of global pharmacovigilance risk management, Dr. Andrea Machlitt, told the panel that it’s received 17,000 adverse event reports, 15,000 of which involved U.S. patients.

Yesterday the 16-member panel agreed that the device shouldn’t be used in women with metal allergies, autoimmune disease, chronic pelvic inflammation or prior uterine procedures. Panelists recommended strengthening the product label to provide more information about potential adverse events and the creation of a patient registry to track adverse events. They also recommended more training for doctors, including how to remove the coils and suggested a protocol be developed to intervene earlier when patients complain about persistent pain.

Although the panel did not take a formal vote and the FDA isn’t bound to follow its advice, the agency often follows the lead of its advisory committees.

Some panelists were critical of the clinical study used to back Essure’s pre-market approval application because it was not randomized, had no control group and failed to provide adequate data on nickel-related side effects.

“How can we not have data on nickel allergy when you have a device that is 55% nickel and 20% of women are known to be nickel allergic?” asked Dr. Peter Schalock of Boston’s Mass. General Hospital. “How can Bayer and the F.D.A. have no knowledge of nickel allergies?”

Other panelists said a new, randomized trial is needed comparing Essure with tubal ligation, to determine whether the adverse events are tied to the implant.

“How can we register an opinion on this if we’re not satisfied with the method [the data] was captured?” said Dr. Joshua Milner of the National Institute of Allergy & Infectious Diseases.

“We can assume it’s the device, but unless we compare, we’ll never be able to answer the question,” added Dr. Grace Janik of Milwaukee’s Reproductive Specialty Center.

The hearing also included testimony from several women detailing severe health problems they attributed to the Essure device, including Gabriella Avina, who said she had taken part in the original clinical trials and had worked for the company, explaining the device to women when it 1st came on the market.

“I am here today, almost 13-plus years later, to say I was wrong,” Avina said, according to the New York Times. “Time has changed my thoughts, beliefs and, most importantly, my health.”

Avina said she was found to have celiac disease, a thyroid disorder and myasthenia gravis, illnesses that required multiple hospitalizations, chemotherapy and transfusions , all after the Essure procedure.

“My health was in a tailspin, and I had failed to connect the dots,” she said. “The only foreign object in my body was the coil.”

Chandra Farmer said she had a hysterectomy last year to remove the Essure device after several years, a solution Dr. Charles Coddington of the University of Wisconsin at Madison called “shooting flies with a cannon,” the newspaper reported. Farmer said she slept almost non-stop, suffered memory loss and hallucinations and collapsed several times from severe muscle weakness.

“My kids would have to tell people, ‘Oh, it’s O.K., she does that sometimes. She’ll get up in a minute,'” she said, according to the Times.

“I had to stop driving, I became depressed. There is nothing more heartbreaking in the world than having your baby have to be your caretaker,” she said, according to the Wall Street Journal.

Material from Reuters was used in this report.

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