It seems to happen far too often: a pharmaceutical is introduced, widely used, and eventually pulled from the market for being unsafe.
Although it was pulled from the U.S. market two years ago, a new study has reported data about the side effects of the permanent birth control device Essure. It is associated with higher rates of chronic lower abdominal or pelvic pain and abnormal uterine bleeding than surgical sterilization.
Interim results of a postmarket study, ordered by the U.S. Food and Drug Administration, show that following each procedure, incidence of chronic lower abdominal or pelvic pain was reported among 9.1% in the Essure group and 4.5% in the tubal sterilization treatment group. Incidence of abnormal uterine bleeding was reported among 16.3% in the Essure group and 10.2% in the tubal sterilization treatment group, the study says.
There were a total of 1,128 women enrolled in the study at 60 investigational sites in the United States with 340 patients in the Essure group and 788 patients in the tubal sterilization group.
Dr. Terri Cornelison, director of the FDA’s Health of Women Program, said in a statement released last Wednesday that “Early results show that Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as their permanent birth control. Also, patients with Essure had higher rates of gynecologic surgical procedures—including surgery to remove Essure—than patients who had tubal ligation. Lastly, pregnancy rates are similar for patients with Essure and tubal ligation.”
The FDA said a five-year follow-up of patients in the study is ongoing, and patients are still completing one-year follow-up visits.
Women experiencing persistent pain and suspect that Essure is possibly the cause should talk to their doctor about what steps may be appropriate, according to the agency. They also said recommend that women who have been using Essure successfully to prevent pregnancy can and should continue to do so.
What’s more, is that The FDA cautions that removing the device comes with its own risks. Patients should discuss the benefits and risks of any procedure with their healthcare providers before deciding on the best option.
Bayer issued a statement in response to the results published on Wednesday:
“The Essure 522 study is a five-year observational study that will not be completed for more than four years, and, as a result, the interim findings are incomplete and are subject to change. This study is ongoing, and the results are interim. Final analyses of endpoints will not be completed until the study concludes’ in 2025. It is, therefore, too early to draw any conclusions…The results of several large, real-world observational studies comparing patients with Essure to patients who have had tubal ligations consistently show that Essure’s safety profile is similar to that of tubal ligation. … Bayer remains strongly committed to women’s health, where we have long been a leader.”
All of this comes after Bayer failed to report thousands of complaints of injuries allegedly caused by its Essure contraception device to the U.S. Food and Drug Administration, according to newly unsealed documents.
It seems like a cut and dry case of “too little, too late.”
If you or someone you know used Essure during it’s time on the market, talk to your doctor!