The U.S. Food and Drug Administration expects to release new guidance on a form of birth control that has been linked to more than 15,000 adverse events, including at least a dozen deaths, by the end of February.
Essure, a permanent contraception procedure, is a small, soft, flexible coil made out of nickel that is inserted into each fallopian tube. Scar tissue forms around the coils, permanently blocking the tubes and preventing eggs from getting into the uterus.
The non-surgical, non-hormonal method was originally manufactured by Conceptus and quickly gained popularity following FDA approval in 2002. Bayer purchased the device for $1.1 billion in 2013.
Over the past decade, women who had the Essure inserted and doctors who implanted it began voicing concerns about serious side effects that were not mentioned on original warning labels. These included fetal deaths, uterine perforations due to broken or unwound coils, and air embolism during removal.
The FDA scheduled a hearing this fall after several complaints were included in a log of more than 5,000 voluntary adverse-event reports on its Manufacturer and User Facility Device Experience Database.
During a September hearing on the device's safety and efficacy, some argued that use of Essure should be limited until more research was conducted. Dozens of women shared stories of chronic and excruciating pain, bleeding that lasted days at a time, hysterectomies at young ages, failed marriages and financial ruin. The agency's Obstetrics and Gynecology Devices Panel didn't take a formal vote.
More scrutiny came in October. A study in the BMJ concluded that women using Essure were more than 10 times more likely to have complications that required corrective surgery within one year when compared with women who underwent another sterilization option called tubal ligation.
Patient-safety leaders have said the delayed scrutiny of the birth control device exposes more serious gaps in the device approval process in the U.S. and they urge better post-market surveillance for flagging adverse events. That concern is underscored by the 21st Century Cures Act, which aims to speed drug and device development and approval.
In its announcement Tuesday, the FDA called the Essure issue a “high priority,” and said it is working expeditiously to conduct an evidence-based review of the available information. It plans to communicate actions publicly within the next three months.
Bayer has continued to vehemently support the product, saying it is supported by more than a decade of research, real world experience and the FDA.
