A panel of independent experts Thursday told the U.S. Food and Drug Administration that not enough research was done to prove the safety of a permanent female sterilization device it approved 13 years ago, and that it should limit its use.
The news is cold comfort to those who wanted to see Essure pulled from the market, arguing the FDA failed to properly assess the medical device's safety and efficacy and ignored the complaints of women over the years.
As of June this year, the FDA has logged 5,093 adverse event reports related to the Essure medical device, including 11 deaths.
The agency's Obstetrics and Gynecology Devices Panel, an independent group comprised of gynecologists, allergists, statisticians and consumer advocates, didn't take a formal vote at a public hearing held Thursday in Silver Springs, Md.
But all 16 members agreed that Essure should not be used by women who have allergies to metal, since nickel is a major component of the device, or women who have autoimmune diseases, chronic pelvic inflammation, or previous uterine surgeries.
The device may still be a good option for women who have been unsuccessful with other forms of contraception and want permanent sterilization, as well as women who can't be anesthetized.
But many among the hundreds of audience members disagreed.
An estimated 1 million Essure devices have been sold around the world, according to its maker, Bayer Healthcare Pharmaceuticals. The majority has been implanted in American women.
Dozens of those women, many in tears, Thursday shared stories of chronic and excruciating pain, bleeding that lasted days at time, hysterectomies at young ages, failed marriages and financial ruin.
A crimson rope divided the audience from the advisory panel. Armed security personnel stood watch, as did police officers.
Some of the most tragic stories came from those who said they considered suicide after facing adverse effects associated with the device.
“I felt less like a woman, less like a human, I became depressed and it was only my faith in God and my loving family that kept me from ending it all,” said Rebecca Howell, who had the Essure procedure done in August 2011.
Most of the audience members who spoke during the meeting called for the device's recall.
Others, like members of Planned Parenthood suggested the launch of a device registry to better track experiences with Essure.
“Studies conducted to date may have provided an incomplete picture of Essure,” Dr. Sanket Dhruva, a clinical scholar at Yale University said prior to the event.
A new study should be conducted to compare the health of women who use the device and women who use different birth control methods, Dhruva said.
The FDA panel agreed that clinical trials had been troubled, because they were not random and did not include a control group. As a result, those trials offered little information, the panel said.
For instance, when the FDA asked if it was possible to draw a link between Essure and various reported adverse events like pain, bleeding, allergic reactions, or unwanted pregnancies, the panel responded with a collective shrug.
“How can we register an opinion on this if we're not satisfied with the method [the data] was captured,” said Dr. Joshua Milner, panel member and chief of the Genetics and Pathogenesis of Allergy Section at National Institute of Allergy and Infectious Diseases.
Panel members later suggested a new randomized trial take place to compare Essure to traditional tubal ligation as a way to determine if some ailments could be tied to the device.
“We can assume it's the device, but unless we compare, we'll never be able to answer the question,” said Dr. Grace Janik, a panel member and OBGYN at Reproductive Specialty Center in Milwaukee, WI.
Others on the panel disagreed and instead suggested a registry to better track adverse events.
Richard Chappell, a panel member and professor of biostatistics and medical informatics at the University of Wisconsin School of Medicine and Public Health said it would now be difficult to recruit random patients for a device that's been reported to be harmful to thousands of patients.
Originally approved by the FDA in November 2002, Essure consists of a small flexible nickel coil that is inserted into each fallopian tube and causes tubal blockage. The implants are placed without a skin incision, through the vagina.
Bayer has repeatedly defended Essure saying it went through rigorous studies and an extensive FDA approval process and that didn't change as Thursday's meeting progressed.
The company said it sympathized with the ailing patients, but “hundreds of thousands of women have benefitted from Essure," Christopher Loder, a Bayer spokesman told Modern Healthcare after public comments ended.
Still, Bayer revealed it has received more than 17,000 adverse event reports for women with the device worldwide, with more than 15,000 coming from the U.S.
The FDA provided no timeline of when it will take action on the panel suggestions, and said it was a high priority for the agency given the many complaints it's received, according to Benjamin Fisher, director of the Division of Reproductive, Gastro-Renal and Urological Devices at the FDA.
In addition to limiting the use of Essure, the panel suggested further training for doctors implanting and removing the device, and said some sort of system surveillance should be put in place to track doctors whose patients suffer more adverse events than normal.
Beyond that, the panel struggled to provide concrete guidance to the FDA on what it should do moving forward.
After the hearing ended, women who said they were victims of Essure took to Twitter to continue their push for a recall.
