The Essure System was approved and marketed as a non-incisional approach to permanent birth control by the FDA on November 4, 2002. The Essure procedure involves placing a small, flexible device called a micro-insert into each of your fallopian tubes. The inserts are made from polyester fibers and metals (nickel-titanium and stainless steel). Once the inserts are in place the body tissue grows into the inserts, blocking the fallopian tubes. Blocking the tubes is intended to prevent sperm from reaching and fertilizing the egg, ultimately preventing pregnancy.
From November of 2002 to present, it is reported that the FDA has received more than 4,000 adverse event reports on Essure and that the original manufacturer has received 16,047 complaints. Complaints received by the FDA range from symptoms such as nausea, chronic fatigue, hives, abdominal pain, pain during and after intercourse, headaches, and abnormal menstrual bleeding to misplaced and protruding coils. The side effects have been severe enough to warrant surgical removal of the coils or total hysterectomies.
It was reported in April of 2015 that the FDA opened an investigation of the Essure system after allegations that the company falsified and altered medical records during clinical trials, failed to report adverse events, deceived the public and the FDA about the device’s safety and efficacy and used defective materials in manufacturing. In 2002, Essure was given premarket approval which shielded the manufacturer from product liability and litigation. If Conceptus violated the conditions of its premarket approval, they may lose their protective status.
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