In 2001, Health Canada approved the use of a medical device that would alleviate the need for women to undergo a procedure to prevent unwanted pregnancy. The device, touted as a permanent birth control measure, is known as the Essure Permanent Birth Control System and is manufactured by the German-based Bayer HealthCare AG, one of the world’s largest pharmaceutical companies. Before the device was approved and made available, an invasive procedure known as tubal ligation was the usual course of action to permanently prevent pregnancy.
The Essure device consists of small metal coils which are implanted in the fallopian tubes to prevent pregnancy and avoid the necessity of tubal ligation.
Recently, numerous reports have been made to Health Canada and to the US Food & Drug Administration (the “FDA”) alleging serious and adverse health effects associated with the Essure Permanent Birth Control System. The complaints number in the thousands and, in many cases, patients who received the Essure implant have undergone hysterectomies to remove the device.
The complaints that the health regulators have received include severe pain, allergic reactions and more serious incidences of perforations of the uterus or fallopian tubes. In addition, migration of the coils has also been observed. Removal of the device is extremely difficult or impossible once the coils have moved. As the device is intended as a permanent measure of birth control, no method was developed or designed to remove or explant the Essure coils.
A safety review was conducted in November 2015 by Health Canada concerning the adverse reports of harm that have been associated with the device. The FDA also carried out a similar review, prior to Health Canada’s investigation. The FDA has recently called for a mandatory study into the matter and enhanced labelling warning of the risks.
In addition to the serious side effects associated with the Essure system, questions are being asked about the initial trials, including how they were conducted and what information was recorded. Original participants have testified before an FDA panel that the information was altered or improperly recorded.
The Essure Permanent Birth Control System is used in many hospitals in Canada. The head of obstetrics, gynecology and reproductive sciences at the University of Saskatchewan stated that over 1,500 implants were performed in Saskatchewan.