A major new safety study has intensified the ongoing debate over Essure, a controversial birth control implant that tens of thousands of women blame for debilitating side effects and extreme pain.
New Study Sparks Controversy In Ongoing Essure Debate
Publishing their research in the Journal of the American Medical Association, a group of French scientists compared the risks of hysteroscopic sterilization (Essure) to those associated with tubal ligation, the standard technique for permanent female contraception. And the results were decidedly mixed, throwing more fuel onto a global fire that has seen Essure’s manufacturer, Bayer, withdraw its birth control implant from most of the global market.
French Insurance Data Used To Assess Complication Risks
The study, conducted in France, used national health insurance claims data to follow two groups of women. Out of a total of 105,357 patients, 71,303 of the women (67.7%) underwent hysteroscopic sterilization, receiving Essure implants. The remaining women, 34,054 patients, underwent the standard laparoscopic sterilization, or tubal ligation, procedure. Then, by analyzing the insurance claims filed in both groups, the researchers attempted to assess the likelihood of three forms of complication:
- procedural complications – complications experienced during or shortly after the initial surgery, either surgical or medical in nature
- gynecological complications – sterilization failure (i.e. the birth control method didn’t work, as indicated by a second sterilization procedure or pregnancy)
- medical outcomes – allergies, autoimmune diseases, thyroid disorder, mental health disorders (as evidenced by antidepressant prescriptions), outpatient visits and pain disorders, as indicated by analgesic and antimigraine drug prescriptions
Behind only the United States, France was Bayer’s second-leading market for Essure before the device was abruptly withdrawn from the European market in September 2017.
Short Study Period Angers Essure Critics
Insurance data was available to follow all 105,357 women for at least one year following their sterilization procedures. That’s not very long, as many critics of Bayer have already pointed out. Medical device complications don’t always present themselves immediately after implantation. At the longest, the study included data lasting three years after the initial implantation procedure, which isn’t very long either, especially when you consider that these sterilization methods are designed to be permanent.
Fewer Surgery Complications, More Gynecological Problems
Keeping these caveats in mind, the researcher’s findings were inconclusive. Women who received the Essure implant experienced fewer procedural complications during their hospital stays, when compared to patients who underwent tubal ligation. But over the next year, patients with Essure suffered a far-higher rate of gynecological problems, many of which resulted in further operations.
Around 5.65% of the women with Essure “required gynecological operation,” the study’s authors write. Only 1.76% of the patients who underwent laparoscopic sterilization required another surgery within the first year. And this difference in re-operation rates continued over the full three-year study period, although the gap between hysteroscopic and laparoscopic sterilization narrowed somewhat.
Higher Risk Of Sterilization Failure
Essure was also associated with a higher risk of sterilization failure. In the study’s first year, Essure failed in 4.83% of patients. Some of these women underwent a second sterilization procedure. Others received a salpingectomy, in which one or both Fallopian tubes are surgically removed. Still other women became pregnant, despite having received a “permanent” sterilization option.
Where contraception is concerned, women who underwent tubal ligation fared much better. Only 0.69% of the women who received the traditional sterilization method experienced a failure within the first year of treatment.
Sterilization failure, however, is a fairly-broad category of complications and, in analyzing the data further, the researchers found that, among those women who experienced a sterilization failure, people with Essure were less likely to become pregnant in their first year. Pregnancies were more common in the group of women who had undergone tubal ligation, but this difference disappeared after three years.
No Difference In Medical Complications, Study Finds
The study’s most-controversial conclusion, though, involves the risk of medical complications, the wide range of side effects and risks that have been reported to the US Food & Drug Administration.
In tens of thousands of complaints, women and medical professionals blame Essure for causing severe pain, migraine headaches, rapid weight fluctuations, chronic fatigue, autoimmune disorders and a host of other problems. But the French study found no statistically-significant difference in medical complications between hysteroscopic and laparoscopic sterilization methods.
Conclusions Few & Far Between
In the end, we have a muddled mix of results. The study’s senior author, Dr. Mahmoud Zureik, admitted as much in an interview with CNN. “Hysteroscopic sterilization was associated with lower procedural complications and increased gynecological complications compared with laparoscopic sterilization,” Dr. Zureik said. “Based on these findings, we cannot conclude that one procedure is safer and more effective than another.”
Even so, Bayer has already come out to “support” the study’s findings. In a statement reported by United Press International, the company said, “Bayer believes it is critically important that women and their health care providers are armed with factual, unbiased information regarding permanent birth control options, given there are misconceptions and blatant untruths spread when it comes to all types of birth control, but particularly hysteroscopic surgery.”
Essure Problems Denounces “Coordinated Marketing Ploy”
Ironically, bias is exactly what the study’s authors have been accused of. Women’s health advocates at Essure Problems have struck out against the French study as a “coordinated marketing ploy.”
When the study was published in the Journal of the American Medical Association, it was accompanied by an editorial written primarily by Dr. Eve Espey, Chair of the OB/GYN department at the University of New Mexico. The editorial did not, however, at first include the disclosure of Dr. Espey’s potential conflicts of interest. In 2015, the teaching hospital where Dr. Espey works received more than $46,000 in funding from Bayer.
Critics & Supporters Agree: Essure Approval Too Hasty
But no one can deny that Essure was rushed to market. Dr. Espey, in her editorial, writes, “although this product is categorized as class III, a high-risk medical device, the device was approved without evidence from randomized clinical trials.” The FDA review of Essure, Dr. Espey says, was “imperfect,” but “the way forward should focus on the best scientific evidence.”
Dr. Sanket Dhruva, a research fellow at Yale, agrees. “We still need a well-designed randomized trial that follows women for at least five years,” Dr. Dhruva told CNN. “This device has been on the US market since 2002 without that study.”