Editor’s note: An expert panel convened by the FDA is mulling over the evidence it heard from about 40 speakers at the day-long hearing on the Essure device on Thursday, September 24 (that hearing is previewed in the post below that was published September 23.)
According to a Reuters story on the hearing, “The FDA asked the panel to discuss whether the device should be restricted in some patient groups, or whether changes should be made to the product’s label. It also asked the panel to recommend whether additional clinical trials should be conducted.
“The committee was not asked to formally vote on their recommendations but the FDA will weigh their opinions as it decides what to do about the device.”
Some additional coverage from yesterday’s hearing:
NBC affiliate KSDK (St. Louis, MO) – FDA hears emotional testimony on Essure
On Thursday, September 24, an FDA panel of 19 experts will re-hash the risks and benefits of the Essure metal coil permanent sterilization device. Representatives of Bayer are also obligated to defend the device, touted as the only non-surgical alternative to tubal ligation. Both the FDA and Bayer have released new information on the device prior to the meeting. The public can listen and watch online Thursday as the hearing is live-streamed from 8 a.m. to 7:30 p.m. Eastern.
On top of the agenda are the safety and side effect risks not documented in the initial clinical trials the FDA used as the basis for its approval. The FDA said in its latest review that some of the side effects “are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.”
The FDA panel may direct Bayer to conduct additional clinical studies on the device. Other considerations on the table are better screening of patients for things like allergies to nickle-titanium and the presence of fibroids, and better training of physicians who place or remove the devices.
Back in May of this year HealthNewsReview.org reviewed a Bayer news release about the Essure coil. We found some contradictions between Bayer’s safety claims and the side effects from the device that have been reported steadily since its approval more than 13 years ago. In a follow-up news release in July, Bayer reiterated its safety claims about the device:
“The safety profile and efficacy of Essure is supported by more than a decade of science and real world clinical experience.”
There are many critics of the device, which has generated more than 5,000 adverse event – or side effect – complaints to the FDA and many more thousands to the device manufacturer. As noted in the comment section of the HealthNewsReview.org news release review, the outrage is real and expanding as dissatisfied users have organized online and in the streets to force a response from the FDA. Many want the device removed from the market.
Erin Brokovich, the legal advocate and activist, started an online petition that has nearly 14,000 signatures demanding that the FDA remove the device from the market. Still others have filed lawsuits against Bayer for medical harms.
Critics have also been pointing to problems with FDA regulation of medical devices more generally. As Dr. Rita Redberg, the well-known University of California San Francisco cardiologist, told HealthNewsReview.org contributor Trudy Lieberman recently, “The emphasis has been on getting drugs and devices on the market quickly, not on making sure that they are safe.” She added that legislation now winding its way through Congress — the so-called 21st Century Cures Act — would lower the bar for safety even further. “Incredibly,” Redberg wrote in a New York Times op-ed, the bill would “severely weaken not strengthen, the F.D.A.’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not.”
After its initial approval of the Essure device in 2002, FDA directed that labeling changes be made in 2011, 2012 and 2013 that included a nickle sensitivity warning, results of a 5-year follow-up of trial volunteers that included reports of pregnancies following the device implantation, and risks of chronic pain and device migration.
The original manufacturer, Conceptus, which sold the device to Bayer in 2013, was cited by the FDA for failing to report user complaints about Essure within the 30 days allowed by law. Critics, in turn, say the FDA has been lax in responding to complaints by patients and in holding the manufacturer accountable for failure to report complaints as required, according to an ABC News affiliate in Arizona.
For its part, the FDA maintains (in a statement updated September 16, 2015):
“FDA sought to determine what long-term complications may be associated with Essure more than five years after placement, because the post-approval study evaluated safety and effectiveness only up to five years. To date, we have found no conclusive evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement.”
However, the regulatory agency failed to enforce its requirement that Conceptus provide post-market safety reports within five years. The safety report was not released until earlier this year by Bayer. The agency also waited nearly a decade to require labeling changes to warn women about potential nickle allergies, and other complications associated with the device.
Below are links to some current articles about the upcoming hearing published by the popular and trade media.
Family Practice News — FDA panel set to vet Essure safety
NPR — FDA Revisits Safety Of Essure Contraceptive Device
Reuters – FDA advisers to weigh concerns over Bayer’s Essure contraceptive
Modern Healthcare – Activists worry Pope Francis’ visit could overshadow Essure safety hearing