Sex

FDA Examines Complaints About Contraceptive Device Essure

An FDA panel heard from physicians, public health experts, company representatives, and numerous women who said Essure had harmed them.

An FDA panel heard from physicians, public health experts, company representatives, and numerous women who said Essure had harmed them. Shutterstock

A Food and Drug Administration panel at the end of September held a meeting to review evidence about the contraceptive device Essure after receiving thousands of complaints from women who say it has caused pain, bleeding, and fatigue, among other symptoms.

The panel of outside experts heard from physicians, public health experts, company representatives, and numerous women who said Essure had harmed them.

Essure consists of metal coils that are inserted by a physician into the fallopian tubes. The coils are designed to promote scar tissue in the fallopian tubes that ultimately blocks the path of the sperm to the egg. The coils can be inserted in a physician’s office without anesthesia and usually become completely effective within three months. The procedure is not reversible and is meant to be a less invasive alternative to surgical sterilization (often referred to as “having your tubes tied”).

Essure is manufactured by Bayer and has been on the market since 2002. The company estimates that about 750,000 women in the United States have had the device implanted.

The hearing on Thursday focused on adverse side effects that many women claim to have suffered after having the device implanted. Women told stories of autoimmune diseases including eczema, lupus, and celiac disease as well as abscesses, tumors, abnormal fatigue, chronic pain, and loss of bowel control. One woman who addressed the panel, Gabriella Avina, explained that since getting the device as part of the original clinical trial she has been diagnosed with celiac disease, a thyroid condition, and myasthenia gravis, an autoimmune disease that causes extreme muscle weakness.

This has led to multiple hospitalizations and transfusions, and has required chemotherapy. Avina had worked for the company when she participated in the clinical trial and had suggested the device to other women, but told the panel she was wrong to do so.

Another speaker, Chandra Farmer, said that the device caused her to have such severe muscle weakness that she would fall to the floor.

“My kids would tell people ‘Oh it’s okay, she does that sometimes. She’ll get up in a minute,'” she told the panel. Farmer also suffered memory loss and hallucinations. She ultimately had a hysterectomy to get rid of the device.

Experts at the hearing questioned whether the company had gotten enough data on the device during efficacy trials.

One line of questioning focused on nickel, a metal that is in the device and is a known allergen. Dr. Peter Schalock of Harvard Medical School asked a company representative: “How can we not have data on nickel allergy when you have a device that is 55 percent nickel and 20 percent of women are known to be nickel allergic? Why is there no data on that in your package?”

The representative said nickel allergies have been noted in the instructions for use since the device was released but argued that many other medical devices (such as heart valves and stents) are made with nickel and that skin tests for allergies don’t accurately predict whether a woman would be allergic to such a device.

Another line of questioning to company officials focused on why so few doctors were trained to remove the device. Dr. Charles Coddington of the Mayo Clinic said many women were forced to have hysterectomies (a surgical procedure to remove the uterus and in these cases likely the ovaries and fallopian tubes, as well) in order to remove the device. He said this was like “shooting flies with a cannon.”

Cynthia Chauhan, the patient representative on the panel, said: “If you don’t have access to someone who can remove it, you shouldn’t be implanting it.”

Some in the medical community stood behind the device. Dr. Reagan McDonald-Mosely, the chief medical officer of Planned Parenthood, said Planned Parenthood has done its own audit of the patients who have Essure and have found very few problems.

“We continue to offer Essure as an important option,” she said.

A representative from Bayer said the evidence of safety continues to grow and argued that the increasing reports of side effects were simply a result of more women choosing Essure.

The panel will make recommendations to the FDA about the future of the device. The recommendations, however, are not binding.