According to a recent study, the U.S. Food and Drug Administration (FDA) have approved a number of ob-gyn medical devices on the basis of faulty data in the previous 15 years. Essure is also one of such device which has been approved even though there are many controversies surrounding it. There are a number of serious irregularities present in the post approval and pre-approval regulations of high-risk gynecology and obstetrics devices. The controversies surrounding the faulty contraceptive coil bring to light the fact that a better understanding of gynecology and obstetrics device regulation is needed.
Many contraceptive devices are harmful
Essure, grouped as a durable contraceptive device which will last a lifetime, is one of the 18 contraceptive devices approved by the FDA in the last 15 years. Its approval was based on insufficient evidence and incomplete post-market follow-ups. These 18 devices have been proven to present a huge risk to the health of patients. These devices were approved because there are no regulations governing post-market supervision or conducting random trials, and also because the approval criteria for medical devices are lower than that applied to drugs. The standard for approval of all kinds of new drugs, whether injectable or oral, is much higher and according to experts, the same should be applied to medical devices.
The Side effects of Essure
Essure is a metal coil that is inserted into a woman’s fallopian tubes. This process irritates the tubes and blocks the eggs from fertilization. Many women who have used this device have come forward with a large number of complaints. These complaints include serious health dangers such as continuous headaches, weight gain, ectopic pregnancy, pelvic complications, miscarriage, and severe complications during unintended pregnancy, pain, uterus puncture, fatigue, hemorrhage, depression, organ damage, rashes, itching, rupture of fallopian tubes, and even death. Many doctors are of the opinion that strict and precise clinical studies should be done by the FDA before approving any medical device and rigid market follow-up should be carried.
Responsibility of the FDA
It has come to light that many medical devices approved by FDA were either proved to be ineffective in clinical trials or failed to pass the test in the post-market follow-ups for safety. It is imperative that strict rules and regulations should be followed before these medical devices are approved so that the women do not face any unnecessary health risks.