Federal health regulators are reviewing the safety of an implantable contraception device after receiving reports of unusual side effects from patients, including fatigue, depression and weight gain.
The Food and Drug Administration says those problems have not been established in studies of the device and are not listed on the product label. But the agency scheduled a September 24 public meeting to consult outside experts about the overall safety of the Essure implant, which is marketed by Bayer.
Regulators said that their review of two follow-up studies conducted by Bayer “found no conclusive evidence” of new or widespread complications “definitely associated” with the device. The company studies were designed to evaluate the safety of the procedure used to implant Essure, the device’s safety after implantation and its effectiveness in preventing pregnancy.
Despite those findings, the FDA says it has continued to receive reports of complications from patients. A review of the agency’s complaint database turned up more than 5,000 reports of problems linked to Essure. The problems most commonly reported by patients included abdominal pain, menstrual irregularities, headache and weight fluctuations. The agency stressed that patient reports are voluntarily submitted, and have a number of scientific limitations, including “incomplete, inaccurate, untimely, unverified, or biased data.”
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 emailed statement.
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