The Food and Drug Administration announced this week that it will hold a public hearing in the fall concerning the safety of an implantable form of birth control that has generated 5,093 adverse-event reports, including about a dozen deaths.
Essure is a permanent contraception in which a small, flexible coil made out of nickel is inserted into the fallopian tubes, blocking sperm from fertilizing the egg. The non-surgical, non-hormonal method gained FDA approval in 2002, and was originally manufactured by Conceptus before Bayer acquired that company in June 2013.
The product's labeling currently warns of long-term risks such as chronic pelvic pain and the possibility of the device slipping out of position into the lower abdomen.
The federal agency found more than 5,000 events related to Essure, in some cases much more severe than the label warnings, were reported to the Manufacturer and User Facility Device Experience database from November 2002 to May 2015.
Among the most serious events were five reports of fetal deaths that occurred in women who became pregnant despite having the device, a death from strep infection following the implantation of the device, another death due to uterine perforation during device placement, and another related to an air embolism during device removal.
Other adverse events included 3,353 reports of pain, 1,408 menstrual irregularities, 1,383 headaches, 966 cases of fatigue, 936 weight fluctuations and 941 cases where the device triggered an allergy or was incompatible with the patient. In 259 cases, the device reportedly broke.
The FDA says it will be difficult to confirm the device caused any events solely on information provided in the MAUDE reports.
The FDA plans to convene a public hearing on Sept. 24 where it will seek feedback to inform recommendations and next steps. According to the regulatory history, Essure has had to update labeling at least three times: in 2011 to include a nickel sensitivity warning; in 2012 to include results of a five-year follow-up that found some women still became pregnant; and again in 2013 to include risks of chronic pain and device migration.
The FDA said that the problem would continue to be monitored to ensure the device does not pose an increased risk to public health and that its benefits continue to outweigh the risks.
In a news release issued in May, Bayer touted a study that it said supported Essure's effectiveness and safety. Of 364 volunteers ages 21 to 40 who used the device for five years, there were no pregnancies and the inserts “were generally well tolerated.” The release also reported serious side effects, such as irregular menstrual bleeding, abdominal pain, and two reports of heavy and continuous bleeding that resulted in hysterectomy.
A Bayer spokeswoman said the company "looks forward to an open and transparent discussion" at the FDA hearing in September.
Amid increasing concerns about the device over the past few years, some criticized the manufacturer for taking too long to present adverse-event findings, for failing to point out that nearly a third of the women in that trial had dropped out, and for underestimating the severity of the pain felt by participants.
Diana Zuckerman, president of the National Center for Health Research, said she is pleased the FDA is looking into concerns about Essure.
"Our center is studying more than 900 women who have had problems with Essure permanent birth control, including chronic debilitating pain, abnormal bleeding and pregnancy," Zuckerman said in an e-mailed statement.
AP contributed to this report.