The number of reported adverse events associated with the permanent contraceptive device called Essure (Bayer Healthcare Pharmaceuticals) has ballooned over the last 19 months, according to an investigation by the US Food and Drug Administration (FDA) in response to complaints about the product.
From November 4, 2002, when the FDA approved Essure, through May 31, 2015, the FDA had received 5093 adverse-event reports on the device through its Manufacturer and User Facility Device Experience (MAUDE) database, the agency reported today in updates to its web page on the device. This figure compares with 943 reports from 2002 through October 25, 2013, an FDA spokesperson told Medscape Medical News.
In other words, the FDA received 4150 reports, or 81% of the grand total, since October 26, 2013, the spokesperson said. The majority were voluntary reports made mostly by women who had received the implants.
MAUDE also receives adverse event reports from manufacturers, distributors, and healthcare facilities.
The agency said that one postapproval study of Essure "did not demonstrate any new safety problems or an increased incidence of problems since the time of device approval." However, the FDA's Obstetrics and Gynecology Devices Panel will hold a hearing on Essure's safety and effectiveness on September 24 as part of the agency's ongoing investigation.
Bayer Healthcare Pharmaceuticals said that it "looks forward to an open and transparent discussion regarding Essure" in September.
"Bayer has been in regular communication with the FDA about the risk-benefit profile of Essure and the informational needs of both healthcare providers and patients," the company said in a statement. "Patient safety is Bayer's top priority."
The company said Essure is "supported by more than a decade of science and real world clinical experience."
Bayer spokesperson Rosemarie Yancosek told Medscape Medical News that it was too soon to comment on the findings of the FDA investigation, such as the surge of adverse event reports since October 2013.
Expanded Explanation of Benefits and Risks
The Essure device is a small flexible coil that is placed in the fallopian tube — one in each tube — through the cervix and uterus. By triggering inflammation, it permanently blocks the fallopian tube by 3 months after insertion, which is done in a physician's office.
The FDA began its Essure investigation after a law firm asked the agency to take the product off the market. The firm was acting on behalf of hundreds of women who said that the contraceptive device migrated from their fallopian tubes, perforated organs, and caused pain, among other adverse events.
The most frequently cited patient problems in the 5093 adverse event reports received by MAUDE were pain (3353), heavier menses and menstrual irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936). Most reports mentioned more than one patient problem.
Other reports fell into the category of device problems. The most frequent ones were patient-device incompatibility, such as a possible nickel allergy (941), migration of the device or one of its components (482), the device operating differently than expected (301), device breakage (259), and malposition of the device (133). Some reports listed more than one device problem.
Seventeen of the 5093 adverse-event reports were coded as deaths, but six of these were mistakenly coded this way. Another five involved fetal deaths that happened in pregnancies after Essure was placed in a woman. The other six reports were based on four adult deaths — one caused by a postprocedure infection, one reportedly caused by a uterine perforation during placement, one related to an air embolism during surgery to remove the device, and one from suicide.
The FDA said that its investigation also considered the possible long-term complications of the device after 5 years.
"To date, we have found no conclusive evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than 5 years after Essure placement," the agency said.
The agency today also updated its explanation of Essure benefits and risks. Besides pain during and immediately after placement, short-term risks include cramping, vaginal bleeding, and pelvic or back discomfort. Some of the long-term risks are ectopic pregnancy, pelvic pain, device migration into the lower abdomen and pelvis, perforation of the uterus or fallopian tubes, and rash and itching associated with a possible nickel allergy.
"At present, clinical studies and individual cases of Essure sterilization failure reported in the scientific literature have not demonstrated an increased risk of neonatal or pregnancy complications when pregnancy is in the uterus following Essure placement," the agency said. "The FDA will continue to monitor the safety of Essure to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks."
More information about Essure is available on the FDA website.
Medscape Medical News © WebMD, LLC
Heartwire © WebMD, LLC
WebMD Health News © WebMD, LLC
Reuters Health Information ©
Send comments and news tips to firstname.lastname@example.org.
Cite this: Essure Adverse Events Ballooned Since Late 2013, FDA Says - Medscape - Jun 24, 2015.