A Food and Drug Administration hearing in Washington, D.C., next week will offer women who suffered adverse effects from a permanent female sterilization method a chance to be heard.
Now, some of those women are staging a hunger strike to make sure Pope Francis' visit to the nation's capital doesn't muffle their demand to recall the device.
Physicians, researchers, patients and industry advocates will gather on Sept. 24 to review the safety and efficacy of Essure, a device that has generated more than 5,000 adverse-event reports.
The hearing coincides with Pope Francis' first-ever address to the U.S. Congress.
The Catholic Church does not approve of any medical birth-control method and some Essure patients have accused the FDA of having deliberately scheduled the hearing during the pope's visit.
The FDA's hearing was scheduled before the pope's schedule was made public.
Still, the Essure Problems advocacy group is planning a hunger strike outside of the FDA after its meeting next week, participants told the Catholic News Agency last month.
They want to keep the spotlight on the estimated 750,000 women who use the Bayer Healthcare product, the only permanent, nonsurgical device approved by the FDA.
Originally approved by the agency 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.
Thousands of women and clinicians have complained of adverse events such as unintended pregnancy, organ perforation and pain.
"The more I did them and followed women through the whole process, the more skeptical I became," Dr. Aileen Gariepy, an assistant professor at Yale School of Medicine who implanted the devices, told Modern Healthcare. The success rate "was all over the place," she said.
The FDA says it will be difficult to confirm the device caused any events solely on information provided in voluntary complaints filed through the Manufacturer and User Facility Device Experience database from November 2002 to May 2015.
According to regulatory history, Essure has had to update labeling at least three times: in 2011 to include a nickel sensitivity warning; in 2012 to include results of a five-year follow-up that found some women still became pregnant; and again in 2013 to include risks of chronic pain and device migration.
One major issue likely to be raised in next week's hearing is the sparse post-market studies evaluating the long-term and real-life experiences of patients and clinicians following FDA approval of products.
Bayer has repeatedly defended Essure, saying the product, originally manufactured by Conceptus, went through rigorous studies and an extensive FDA approval process.
In an earnings call last year, former CEO Olivier Brandicourt noted that no device is perfect. “Of course, like with every single medical device, you can see some complications sometimes,” he said.
An FDA committee will make final recommendations based on information gathered at the hearing.
Some experts warn that flaws in the FDA post-market surveillance systems could be worsened by the 21st Century Cures Act, a federal bill designed to speed the development and approval of devices and drugs.
Under the current system, it takes years of collecting evidence before FDA warnings are issued on devices or drugs that seem to cause problems, said Lisa McGiffert, director of the Consumers Union Safe Patient Project.
"So we shouldn't be lowering the bar," she said.
