Essure—a permanent birth control device made by Bayer—has been linked to thousands of injuries and hundreds of deaths.
Since Essure’s approval in 2002, women have reported approximately 10,000 related adverse events to the Food and Drug Administration (FDA).
The FDA held a public meeting in 2015 to discuss the safety of the Essure System, during which it was revealed that the number of adverse event reports was closer to 15,000.
Experts have expressed concerns over the study methods used to test Essure’s safety. They point out that both premarket and post-market studies do not meet the highest standards of scientific rigor. As a result, Essure use in the real world may be far more dangerous than testing indicates.
The FDA has ordered a “black box” warning to be added to Essure, but many women consider this to be too little, too late. They’re calling for Essure to be pulled from the market, with many women filing lawsuits alleging that the device is unreasonably dangerous and the source of serious, permanent harm.
Considered a game-changer when it hit the market in 2002, Essure was the first device to provide women a non-surgical alternative to tubal ligation (having one’s tubes tied).
Conceptus, Inc. developed Essure and received FDA approval for the device in 2002. Bayer obtained the rights to Essure when it bought Conceptus in 2013.
Essure consists of two tiny metal coils that are inserted into the fallopian tubes through the cervix and vagina. The procedure typically takes less than an hour to complete and most patients resume full activities within a couple of days.
Over a three-month period, the coils prompt the formation of scar tissue that forms a barrier against sperm reaching the eggs. Women must use an alternative form of birth control while the scar tissue forms. Following a confirmation test to ensure the fallopian tubes are obstructed, Essure should work permanently. (The procedure is irreversible.)
According to Bayer, Essure is more than 99% effective at preventing pregnancy and safe for the vast majority of women. However, these claims have been called into question by a large number of patient complaints, and by formal research.
Thousands of Essure Complaints Logged with FDA
The FDA tracks drug and medical device problems through its adverse event reporting database. Manufacturers are required to report adverse events to the FDA, but patients may also report problems directly.
From Essure’s approval in November 2002 through December 31, 2015, the FDA received 9,900 adverse event reports about the device. Reported problems included:
- Pain/abdominal pain
- Heavy menstruation/menstrual irregularities
- Weight fluctuation
- Patient-device incompatibility (such as metal allergy)
- Migration of device or device component
- Malposition of device
- Device not operating as expected
- Device breakage
- Device difficult to insert or remove
In addition, the FDA received 26 reports of Essure-related deaths, including four adult deaths, 15 reports of pregnancy loss, and two reports of infant death after live birth.
The FDA also received more than 600 reports of pregnancies in patients using Essure. About half of these resulted in pregnancy loss.
In response to Essure safety concerns, the FDA held an advisory committee meeting in September 2015.
During the meeting, scientific data on Essure was discussed, experts gave their opinions on the device, women testified about their experiences with the device, and Bayer representatives answered questions from panel members.
Dr. Andrea Machlitt, a Director of Risk Management at Bayer, told the panel that the company had received 17,000 adverse event reports, including 15,000 from U.S. users. The FDA revealed that in the previous three years, Essure complaints had increased by a jaw-dropping 1,400%.
According to a former FDA employee who now works as an analyst with the consulting firm Device Events, the actual number of Essure fetal deaths exceeds 300.
Accuracy of Essure Test Data Questioned
As reports of Essure problems increased, experts began reviewing the studies used to approve the device, as well as studies performed after approval, and found some serious flaws.
Pre-approval studies for Essure used data from 745 women followed for five years after device implantation. Those studies showed that none of the women became pregnant, with adverse events observed in 2.6% of women in one study and 9% in the other. Observed adverse events included:
- A coil perforated the fallopian tube
- A coil was expelled or lodged elsewhere in the body
- Painful intercourse
- Painful menstrual periods
- Surgery to remove a misplaced coil
Despite these side effects, FDA approved Essure based on the fact that no pregnancies were observed in the two studies. One condition of approval, however, was that post-marketing studies would need to be conducted (FDA often orders post-approval studies).
Data limitations for these studies were addressed in a New England Journal of Medicine article. The study found:
- Few of the women in the premarket approval studies were followed for more than one year, even though Essure is meant to last a woman’s lifetime. Only 632 of the 745 women were followed up at one year for effectiveness outcomes, while just 197 of the 745 women were consulted after two years.
- The results of the post-approval studies (meant to provide five-year follow-up data on patients in the pre-marketing approval studies) were not disseminated in a timely manner. As of October 2015, one post-approval study remained unpublished, and the other had only recently been published. The published study, furthermore, only completed five-year follow-up for 71% of patients.
- Both pre-approval and post-approval studies excluded key data and therefore contain biased results that made it difficult to determine the true safety and efficacy of Essure.
- Pre and post-marketing studies did not include a comparison group for women undergoing the alternative tubal ligation procedure.
The NEJM study author writes, “Given the limitations of the relevant studies, it’s not surprising that so many years passed before safety issues with Essure were recognized. The evidence suggests that [Essure] is nether as effective nor as safe as the premarketing-approval evaluation indicated.”
Results from one of the long-awaited follow-up studies finally were published in the April 2015 issue of the Journal of Minimally Invasive Gynecology. Adverse events from the study (based on five-year follow up) included:
- Hysterectomies (4% of women)
- Heavy periods (38%)
- Recurrent pelvic pain (5%)
- Recurrent painful periods (6.7%)
- Painful intercourse (4%)
But because this study—like the pre-marketing studies—lacked a comparison group, it’s difficult to say whether these risks are excessive.
In contrast, third party research not funded by Bayer and not subject to the shortcomings found in other studies has produced starkly different results. For example, a 2014 study that compared Essure to laparoscopic sterilization found that the risk of pregnancy using Essure was more than 10 times greater over a 10-year period than with the traditional sterilization method.
The following year, a study published in the British Medical Journal found that one year after receiving an implant, 2.4% of Essure patients required follow-up surgery, compared to only 0.2% of women who underwent traditional sterilization surgery. Extrapolated across all U.S. Essure users, the study suggests that 150,000 American patients have required or will require additional surgery.
FDA Orders Black Box Warning for Essure
In an effort to “inform patients of potential risks” from Essure, in February 2016 the FDA said that it intends to require a boxed warning: the FDA’s strongest warning. The exact language of the warning has yet to be determined.
The FDA also ordered Bayer to conduct a new Essure post-marketing study, and proposed coming up with a “patient decision checklist” to help patients better understand the risks of Essure.
Resources for Essure Victims
Victims of Essure side effects may find support in the community of others who have suffered similarly. For example, one disgruntled Essure user founded the Essure Problems website and Facebook page to warn other women about the device and share her experience. The Facebook group now has more than 27,000 members.
Moreover, famed consumer advocate Erin Brockovich launched the website Essure Procedure as a place for women to share their stories and concerns about Essure, and to call for a ban of the device.
Bayer Facing Hundreds of Lawsuits
Essure users have filed hundreds of lawsuits nationwide alleging that Bayer (along with Essure’s original developer, Conceptus) knew about the device’s risks and intentionally withheld information about them in order to continue marketing Essure. Specific plaintiff allegations include failure to warn, negligent misrepresentation, and negligent manufacture.
Based on widely reported Essure side effects, attorneys are ClassAction.com are now exploring legal action against Bayer.
If you experienced serious health complications after being implanted with Essure, complete a free case review and find out whether you may be eligible for compensation. It costs nothing to speak with us, and you pay nothing unless we win your case.