Holly Kelly Ennis
French Study on Hysteroscopic and Laparoscopic Sterilization Heightens Controversy Over Essure
A study released this week in the Journal of the American Medical Association (JAMA) and the associated editorial comment written by long time Essure proponent and Bayer funded research consultant, Dr. Eve Espey, regarding the long term safety of Essure sterilization versus laparoscopic sterilization procedures has exacerbated the worldwide controversy over the safety of Essure. The study, Association of Hysteroscopic vs Laparoscopic Sterilization With Procedural, Gynecological and Medical Outcomes, conducted in France, purports to compare the risks of procedural complications (surgical and medical), gynecological complications (sterilization failure which includes salpingectomy, second sterilization procedure, or pregnancy; pregnancy; or reoperation) and medical outcomes (including allergic reactions, autoimmune issues, thyroid disorders, migraines, sickness absence, etc.) between patients who underwent laparoscopic sterilization versus those women implanted with Essure.
The study, which utilized the French national hospital discharge database linked to the health insurance claims database, studied women between the ages of 30-54 receiving a first hysteroscopic or laparoscopic sterilization between 2010-2014 and were only followed up through December 2015. The study, although it provided some usable data, is fraught with shortcomings and clearly fails to prove, as is claimed by Bayer, that Essure is safe. The first problem with the study is that it failed to include 25% of the population who may have undergone either procedure. Since health insurance data were used, women without coverage were excluded, which was a limitation in the study. The researchers wrote in their study that since "this covers 75% of the French population, these findings are likely to be generalizable." However 25% is a rather large percentage to "extrapolate" or to assume certain generalizations.
A greater flaw in the study is the limited time frame in which the women were followed, some as little as one year following the sterilization procedure. It is well known that often medical complications arising from the Essure device do not develop or present until three or more years following implantation. The Essure device can migrate or perforate the tubes or uterus at any time, even several years following the initial procedure. Additionally, many medical complications from the device, including thyroid disorders and autominnune issues often take several years to manifest and be diagnosed. Three years is a grossly insufficient time frame to make confident medical findings regarding the development of these types of medical issues. Even more disconcerting is the fact the study admits than only half (51.5%) were followed for at least three years. It is unethical for a study to claim the lack of medical outcomes wherein the authors admit that only 50% of the women were studied for a mere three years.
The study claims to have followed 105,318 women (99.96%) for at least one year and the study showed interesting finding based upon the one year study. Among the women in the study, 71,303 underwent hysteroscopic and 34,054 underwent laparoscopic sterilization. Hysteroscopic sterilization was found to be associated with a significantly higher risk of sterilization failure than laparoscopic. In the study, 4.83% of hysteroscopic patients saw sterilization failure after one year and 5.75% after three years, compared with 0.69% and 1.29% of laparoscopic patients. Futhermore, hysteroscopic sterilization was associated with a significantly higer risk of a woman undergoing a second sterilization procedure at one year than was laparoscopic sterilization. (4.09% vs 0.16%). Accordingly, it is unclear how Bayer through its highly orchestrated media stories are somehow touting Essure as a safer alternative.
The study had other limitations as well. The study noted it used administrative databases and accordingly, individual disorders reported by patients or physicians and collected into a database could NOT be examined. Accordingly it is unclear whether individual reports by a patient to her physician of abdominal pain, cramping, heavy bleeding, joint pain, dental problems and a plethora of other symptoms would be accounted for in the study.
It is also interesting to note that an editorial to the study, Evaluation the Long-term Safety of Hysteroscopic Sterilization, was orchestrated to be released concurrently with the study. The editorial, was written by Dr. Eve Espey and Dr. Lisa Hofler. The editorial article was corrected to disclose the Conflict of Interest Disclosures for Dr. Espey revealing that she has received research funding from Bayer. Espey admits that the approval process for Essure was flawed. "Although this product is categorized as class III, a high-risk medical device, the device was approved without evidence from randomized clinical trials. Additionally, in the phase 3 postmarketing follow-up trial, 30% of the original cohort was lost to follow-up for 5-year outcomes As with other contraceptives, reports of health problems linked to the tubal inserts paralleled increased use." Dr. Espey admits that, "Although the FDA review process for Essure was imperfect, the way forward should focus on the best scientific evidence."
To that end, it should be agreed that the product should be suspended pending real scientific trials studying the device for at least five years. Other doctors seem to agree: "This study provides a degree of reassurance -- but not certainty -- that there is no increased risk of medical complications from Essure compared to women getting laparascopic sterilization after 3 years; we must take that result with a grain of salt," said Dr. Sanket Dhruva, a postdoctoral research fellow at Yale University who was not involved in the study but has written about Essure. "We still need a well-designed randomized trial that follows women for at least five years," he said. "This device has been on the US market since 2002 without that study."
Other physicians agree with the removal of Essure from the marketplace. Professor Carl Heneghan, director of the Oxford Centre for Evidence-Based Medicine in the UK, said: “If you want to make a lot of money – where you can access a market with poor regulation that allows you to sell inferior products – then medical devices are the one. Professor Heneghan, who is also a practicing GP, believes that some manufacturers seek out bodies with the lowest requirements and that Essure should be off of the market. He added: “Essure is made from, nickel, titanium, iron, chromium and plastic. These are ridiculous things to stick inside a human being. “A large percentage of women are allergic to nickel. That is why we remove it out of jewellery.”
Dr. Espey noted, "The future of hysteroscopic sterilization is uncertain given the powerful and highly publicized grassroots effort to ban the device, the chilling effect of the FDA black box warning and the specter of class action litigation." This is perhaps the one point we can agree upon. The future of hysteroscopic sterilization should be uncertain until scientific trials are completed and product developments made, absolutely ensuring these products are safe. And if it take a "grassroots effort" or litigation to ensure that happens, then so be it as it is apparant that we can not entrust the FDA, Bayer or physicians with inherent conflicts who put profits over patient safety with this important and essential task.
If you or a loved one has been injured by Essure, contact the attorneys at Ennis & Ennis, P.A at 1-800-856-6405 or visit us online at www.Ennislaw.com.