The FDA announced new measures to communicate the risks of permanent contraceptive device Essure, which has been linked to severe complications. The regulatory agency called for a new, mandatory clinical study for Essure to determine certain risk factors for women. The FDA also plans to require changes to Essure labeling, including a “black box” warning label and a Patient Decision Checklist outlining the risks and benefits of permanent birth control devices. Additionally, the agency issued a draft guidance providing the public an opportunity to comment on the labeling before it is finalized, and to increase patient/physician understanding of Essure’s risks.
Thousands of women implanted with the device have experienced complications, including pregnancy, persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions. Many women have had complete hysterectomies to remove the problematic device after its side-effects became unbearable. Call us today at 888-985-7228 for a free legal consultation if you have experienced any adverse side-effects after being implanted with Essure. You may be entitled to compensation.