Last year, drugmaker Bayer announced that it would discontinue sales of the controversial birth control device Essure outside of the U.S. And now Bayer says it will also stop selling Essure within the U.S., too. However, Bayer stressed in a press release that the removal of Essure from the U.S. market was for “business reasons” and that the company's confidence in the safety of Essure has not changed.
“Bayer emphasizes this is purely a business decision—not a recall—due to declining sales over the past several years,” Courtney Mallon, Deputy Director, U.S. Pharmaceuticals Product Communications for Bayer, tells SELF. “Bayer will discontinue sales/distribution of Essure at the end of this year, and women who are interested in Essure as their contraception of choice will be able to receive the procedure through the end of 2019.”
Essure, which was approved by the FDA in 2002, is a flexible coil that's implanted in each of a patient's fallopian tubes without a surgical incision.
After it's implanted, a barrier of scar tissue forms around those coils over a period of three months, which keeps sperm from reaching the patient's eggs and prevents pregnancy. But the device has been the subject of a fair amount of controversy over the past few years.
"The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen," FDA commissioner Scott Gottlieb, M.D. said in a statement last week. "As the FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns."
Among those actions was the FDA's decision in 2016 to have a black box warning added to Essure, designed to make sure patients better understood the risks associated with the product, including persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding, and allergy or hypersensitivity reactions. The black box is the strongest warning that the FDA issues, and indicates that research has found that the product comes with a significant risk of serious or life-threatening effects.
The FDA issued the warning after it heard complaints from 5,000 people that Essure was involved in unintended pregnancies, miscarriages, stillbirths, and severe pain and bleeding. Some patients also reported that it broke apart inside them.
And just a few months ago, the the FDA announced that it was putting restrictions on the sale and distribution of Essure. Under those restrictions, the FDA limited sales of Essure only to doctors and healthcare facilities who used an FDA-approved patient-doctor discussion checklist, reviewed it with patients, and gave them the opportunity to sign it before Essure was implanted, FDA spokesperson Deborah Kotz previously told SELF.
Dr. Gottlieb reassured patients that the FDA plans to “remain vigilant in protecting patients who’ve already had this device implanted,” even when Essure is taken off of the market.
Gynecologists have some mixed feelings about the loss of Essure.
On the one hand this is a loss for those who wanted “the ultimate 'set it and forget it' method of birth control,” Lauren Streicher, M.D., an associate professor of clinical obstetrics and gynecology at Northwestern University Feinberg School of Medicine, tells SELF, meaning that you get it implanted and (hopefully) never have to really think about it again.
“Although [Essure] was not the best choice for all women desiring sterilization, it was the closest female procedure akin to male vasectomy,” Melissa Goist, M.D., an ob/gyn at The Ohio State University Wexner Medical Center, tells SELF. But, unlike a surgical sterilization procedure (tubal ligation), getting Essure doesn't require surgery or general anesthesia. The recovery after getting Essure is, therefore, much less intense than that of a tubal ligation, Dr. Goist says.
The loss of Essure will also leave a gap in the market for those who want permanent sterilization but need to avoid surgery or can't tolerate hormone-based contraception for health reasons, Jon Hathaway, M.D., an ob/gyn with Indiana University Health, tells SELF. "Our main use of Essure was in women with morbid obesity who could not tolerate hormone-based contraception and were too risky for laparoscopy," he says. "Now, more of these women will have the riskier surgery because the Essure device is not available to them in the United States."
But, while some people were very satisfied with Essure, others had issues. “And for those who had problems, they really had problems,” Dr. Streicher says, which were widely publicized in recent years. So it's not surprising that many patients have apparently already stopped considering Essure as an option. "Given all the negative press over the last couple of years, we haven't really put in very many at all," Mary Jane Minkin, M.D., a clinical professor of obstetrics and gynecology and reproductive sciences at Yale Medical School, tells SELF. "I really haven't seen too many new Essure users. Women have pretty much stopped using it."
If you’re interested in getting Essure, you can still do so before the end of 2019—or you can consider some other options.
Tubal ligation is definitely an option, Dr. Streicher says but it requires general anesthesia and undergoing actual surgery. So, if you’re in a committed relationship with someone who has a penis and you want permanent birth control, it may be a good idea to explore the idea of a vasectomy with your partner. “It’s far and away safer than any tubal ligation, done in any manner,” Dr. Minkin says, noting that the potential complications associated with tubal ligation include blood clots and those related to general anesthesia.
But if a vasectomy isn't the right option for you and your partner, Dr. Minkin then recommends looking into an IUD. Dr. Goist also recommends looking into a form of long-acting reversible contraception like an IUD, or the implant. “[They] will continue to be great options that are quick and allow a woman to return to her activities immediately,” she says. And if you have severe period symptoms, a hormonal IUD or implant may ease some of those issues in a way that tubal ligation wouldn't, Dr. Minkin points out.
If you want a permanent (or as close to permanent as possible) form of birth control, it’s ultimately up to you which one you choose, Dr. Hathaway says, so talk to your doctor about your options. “Each patient has their own set of risks to be concerned about and a blanket statement or policy is impossible,” Dr. Hathaway says. “If there was one ‘best’ way to prevent pregnancy for everyone, then there would be no need or demand for the myriad of ways we currently have to prevent pregnancy.”