Deaths, Complications Bring Demand for Further Study of Essure
According to MassDevice, the U.S. Food and Drug Administration (FDA) is pushing for new research on the safety and risks of the Essure permanent contraception device following a spike in complaints and complications.
Reasons for Essure Concerns
In the 13 years since Essure’s approval, the FDA has received more than 5,000 complaints from consumers following device usage for a slew of problems from pain and menstrual irregularities to device breakage. There have been five confirmed fetal deaths, although analysts say that number is likely underestimated, and four adult deaths arising from issues like infection and uterine perforation.
At a September 2015 meeting of the FDA’s Obstetrics and Gynecology Devices advisory panel, the agency stated they had observed a spike in complaints filed over Essure of nearly 1,400% in the past three years.
At this hearing, one of Bayer’s directors informed the panel they had received 17,000 adverse event reports. Furthermore, an October 2015 study discovered that a woman who chose the Essure implant over laparoscopic sterilization was more than 10 times as likely to require post-procedure surgery.
What Follows for Essure?
These shocking statistics led to an FDA mandate demanding Bayer to initiate a new clinical study and guidance on the use of the Essure contraception device. This trial is largely intended to determine what women face increased risk of adverse reactions.
The post-market surveillance study is to be conducted by analyzing the rate of complications in comparison to laparoscopic tubal litigation. These measures include complications such as unplanned pregnancy and level of pelvic pain. It will also include an evaluation regarding the complications affect upon the patient’s quality of life.
In addition to this, the company has been order to include box warning labels which include the potential for adverse events. These actions will allow women to make more informed decisions about whether or not Essure is the right treatment for them, and reflects the FDA’s recognition of a need for more strenuous research to determine who is most at risk of complications.
In accordance with the desire for patient’s to be more informed about their possible treatments, the FDA is recommending a “patient decision checklist” for physicians to discuss with women so they have more data at their disposal. Likewise, they recommend that those who receive the implant return three months after their surgery for a check-up to confirm the device is correctly oriented and healed. Several seek to do more than research the problem, and instead proactively seek to curtail its use.
After the spike in complaints from the mass adverse risk reports, a September 2015 advisory panel voted to recommend that use of the device be limited until more was known about its safety. And last year Rep. Mike Fitzpatrick sponsored a bill which would ban sales of the contraception altogether in the U.S.