Advisory Committee Recommends Registry, Training for Bayer’s Essure

An FDA advisory panel recommended Thursday that a patient registry be created to document adverse events related to Bayer’s Essure contraceptive implant.

The agency has received more than 5,000 complaints — including four deaths — related to Essure, which Bayer acquired when it bought Conceptus in 2013. During an all-day public meeting, the Obstetrics and Gynecology Devices Panel heard from experts and women who claimed they’d been injured by the device.

One of those testifying was Gabriella Avina, who developed five autoimmune diseases, including celiac disease and myasthenia gravis, after using Essure. Before becoming ill, she served as a spokeswoman for the implant, traveling the U.S. informing clinicians and nurses of the device’s promise and answering questions on the Essure website in a section called “Ask Gaby.”

“My health was in a grave tailspin, and I did not connect the dots,” she testified. She has since had her coils removed.

Other women testified that Essure caused bleeding, autoimmune diseases, painful sexual intercourse, unplanned pregnancies, weight gain, tooth and hair loss and excruciating pelvic and abdominal pain.

In documents released ahead of the meeting, Bayer acknowledged Essure’s risks, but insisted the implant has helped many women.

Representatives from Planned Parenthood and the National Women’s Health Network supported the idea of a registry. Planned Parenthood recommends the device as one of many birth control options.

Others, however, questioned the product’s safety. Mark Bell, a metallurgical expert with more than 30 years of experience, said his analysis of the device found latent manufacturing process defects.

He recommended suspending sales of the product until the defects are fixed.

Bell’s concerns were shared by panelists and patients who questioned the use of nickel in the implant. Most of the more than 20 patients in attendance said they had nickel allergies, while many panelists had concerns about the lack of data related to sensitivity to the metal.

Yale University obstetrician Aileen Gariepy was among those questioning the data backing Essure. She said 85 percent of women who got the implant were sterile three months after the procedure and those who weren’t were 10 percent more likely to be pregnant at one year versus laparoscopic sterilization.

Sarah Sorscher, with Public Citizen’s Health Research Group, said the pivotal five-year study and follow up of women implanted with Essure were flawed because women weren’t asked if they experienced persistent pain at every visit.

Read the FDA’s background materials at www.fdanews.com/092815-FDA-materials.pdf. Bayer’s documents are here: www.fdanews.com/092815-bayer-materials.pdf. — Elizabeth Hollis