Black box warning order clouds future for Bayer's Essure
Last week, the FDA mandated Bayer add a black box warning to Essure, a permanent form of birth control involving the insertion of flexible coils into the fallopian tubes. Since Essure’s approval in 2002, critics have been calling for its removal from the market.
While the device has been beneficial for many of the 750,000 plus women who have used it, some women contend the risks outweigh the benefits.
Social media has enabled these women to more strongly advocate for changes to the FDA’s label for the drug. Even with the addition of a warning to the device, it will still take time for the wording to be approved and marketing materials to be updated.
Benefits versus risk
While still in draft guidance stage, the proposed warning advises women of a number of serious risks associated with Essure including persistent pain, device migration, and abnormal bleeding. The FDA additionally ordered Bayer to conduct post-marketing studies to generate further information for evaluating the long-term safety of the device.
The draft guidance for a black box warning won’t be the end of the FDA’s involvement, however.
“The FDA is looking more closely at Essure and doing active follow-up to assess the risk-benefit situation and ensure that the risks associated with Essure don’t outweigh the benefits,” said David Rosen, a lawyer at Foley & Lardner LLP. Involved in public policy, Rosen was on staff at the FDA for almost 15 years.
Essure is promoted as the “the only permanent birth control with a non-surgical procedure” and as a “permanent birth control that works with your body to create a natural barrier against pregnancy.”
In fact, a very vocal and well-organized group of patients who say they have suffered life-changing injuries related to Essure argued the device should be taken off the market.
The intersection of social media and patient advocacy
Since Essure’s first approval in November 2002, a number of complaints have been filed with the FDA’s Manufacturer & User Facility Device Experience database. Over the past several years, there has been a notable increase in the number of complaints, as well as in the tenor of the conversation around them.
One of the driving forces behind these changes is the growing power of patient advocacy coupled with social media, including the “Essure Problems” Facebook page, which has a community of more than 10,700 women. Another group, the Essure Problems Lawsuit Facebook page has more than 2,500 members.
The women in these communities are clinically knowledgeable and responsive to media. They are passionate about their cause, largely because of the pain and diminished quality of life they say they have suffered as a result of implantation with Essure.
According to Rosen, the recent acceleration in complaints can be tied to the awareness generated by these social media groups. “Because of social media and increased awareness, it’s a lot easier to file regulatory complaints. The process is much more transparent than it was previously,” he explained.
Not as advertised
Many women said the promise of an effective form of birth control with little or no downtime didn’t come true.
Sharon Laakko, an Essure patient who lives in Michigan, shared her experience. “I have been [having] Essure problems since 2012 and am now committed to bringing awareness to others about Essure problems. I heard from doctors that Essure does not cause the type of pain that I have had.”
Laako’s daughter also had Essure and developed significant pain.
“[My daughter] almost lost her job because she was in so much pain. This type of pain changes your attitude. She lost precious time with her children and could not continue nursing her last child. These are times that cannot be recovered,” Laako said.
A doctor agreed to give her daughter a hysterectomy at age 31 despite thinking it wouldn’t help. But it led to substantial improvement. “Her back pain and hip pain were gone by the time she got to the recovery room. The problem was that her Essure coil was perforating her cornu (the point where the fallopian tubes and the uterus meet), which was probably the cause of the pain.”
Laakko’s story is one of many which can be found online, documenting medical histories involving Essure-related problems.
However, the company has pushed back on criticisms of the device.
"Essure is an important permanent birth control option with a positive benefit-risk profile. Bayer will continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use of Essure," Bayer said in a statement following the FDA's announcement.
""Patient safety and appropriate use of Essure are our greatest priorities," added Dario Mirski, the head of medical affairs in the U.S.
The other side of the story
Despite the fact numerous complaints tied to Essure, Rosen does not see the product being removed from the market—especially not in the near term.
“Bayer is a responsible company. They have a long track record and want to make sure that their products meet appropriate standards for safety and efficacy. They are now working with the FDA to review risks and come up with appropriate language for the black box warning and other measures that can be used to decrease overall risk,” Rosen said.
In the FDA’s announcement of the draft guidance, Dr. William Maisel, FDA deputy director of science, acknowledged the need for greater knowledge of potential complications related to the device.
According to Maisel, “[the actions] also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
The patient marketing brochure for Essure features Important Safety Information (ISI) on the second page, warning women who may want to become pregnant in the future to not use Essure.
The most common side effects are listed as pain during the procedure, nausea, vomiting and vaginal bleeding around the time of implantation. It also claims 88% of women who underwent the Essure placement procedure rated tolerance of the placement procedure as good, very good, or excellent.
Although the black box warning will eventually make its way onto patient materials, it won’t happen overnight, according to Rosen. The FDA is currently seeking comments on the draft guidance over a 60-day period.
“Just as it takes time to collect marketing experience, the process of updating warnings also takes time. During that time, the company works with the FDA to determine the way forward,” Rosen said.
“I estimate that it will take close to 180 days or longer for all of the marketing materials to be updated.”