The FDA announced that it expects to release new guidance regarding the Essure “permanent” birth control device by the end of February 2016. The agency wants to conduct an evidence-based analysis of Bayer’s product before making its recommendations. We live in hope that the evidence is not just more garbage provided by Bayer.
The FDA says to expect new Essure guidance by February 2016. Bayer’s “permanent” birth control device has caused suffering for tens of thousands of women, even resulting in close to a dozen deaths. While the announcement of “new guidance” is welcome, it is astounding that it’s taking the agency so long.
The Essure device, for those unfamiliar, is a metal coil made of titanium, nickel and including polyethylene terephthalate (PET) fibers. The coils are inserted into the fallopian tubes, where they cause scar tissue that is supposed to block pregnancy by preventing eggs from entering the uterus.
Essure was developed by Conceptus as a non-surgical (untrue), non-hormonal birth control device. It was given FDA fast-track approval in 2002, using a system that is normally reserved for drugs and devices of a life-saving nature. Bayer bought Essure from Conceptus in 2013. It had a $1.1B price tag.
However, all did not go as planned by, well, anyone involved with this product. Despite being approved by the FDA, Essure has left a trail of devastated lives over the past decade. Women have been experiencing horrible side effects that weren’t on the original warning labels. These side effects include:
- Fetal death (despite claims, Essure has a 10% failure rate)
- Uterine perforations
- Migration, leading to other organ perforations
- Air embolism during removal
- Hair and tooth loss
- Unrelenting pain
Records show that a file containing almost 17,000 complaints was never submitted to the FDA during the accelerated approval process. Even today, many complaints aren’t being taken seriously. To the FDA’s credit, it finally scheduled a hearing in September 2015 after reviewing 5,000 adverse event reports in its Manufacturer and User Facility Device Experience Database.
The September hearing saw arguments that Essure use should be restricted until more research could be done. Victims of the product shared their stories, which included the above side effects, as well as prolonged bleeding (often for days), hysterectomies in their 20s and 30s, job loss, financial difficulties and failed marriages. The FDA’s Obstetrics and Gynecology Devices Panel didn’t vote that day.
A month later, the BMJ featured a study the conclusion of which was that Essure patients were 10 times more likely to experience complications ending in corrective surgery within one year of implantation than were those women who chose tubal ligation.
The agency said that Essure is a “high priority” issue and it will work expeditiously to complete an evidence-based review. I find myself cautiously optimistic as I wait for the results of that review. On one hand, it’s good news that the FDA is finally acting. On the other hand, I am concerned as to what evidence will be reviewed.
Records show that data was altered or completely excluded from the approval process. The studies on safety and efficacy were sponsored by the manufacturer and, therefore, open to corporate influence. Patient questionnaires were even changed, with researchers crossing out references to pain and other complications.
If the FDA includes evidence provided solely by Bayer, I fear this review will accomplish nothing. Bayer has and continues to defend Essure with claims of over a decade of research and real world experience, plus the FDA’s approval.
I hope the FDA will take into account the patient reports, both from their database and from groups such as Essure Problems, a grassroots movement dedicated to helping women suffering because of the product and to getting it off the market. I also hope it will listen to the many doctors who work to help those who are suffering.
As a friend used to say, “We live in hope.”
We also work while we wait. Rep. Mike Fitzpatrick (R-PA) introduced the “E-Free Act” this fall. The bill calls for the removal of Essure from the market. We can lobby our representatives, asking for their support. We can continue to talk about the issue. I’m amazed at the number of people I meet who have never even heard of Essure. The court of public opinion is, while not always right, a powerful tool. In this case, it can be helpful.
Never give up. Keep talking. Keep hoping.