(Newswire.net — September 9, 2018) –Since the medical devices were introduced for the purpose of female sterilization, Essure came on the market in 2002 and it was hailed as a non-surgical alternative to tubal ligation and hysterectomy. This permanent birth control measure was marketed as being a powerful choice for women as it was convenient and easy to insert, requiring no invasive surgery or incisions unlike other sterilization methods.
Essure works to prevent pregnancy by triggering scar tissue to grow, creating a barrier that blocks sperm from reaching a woman’s egg. A 4-centimeter metal coil is inserted through the cervix and placed into both fallopian tubes.
While the device was hailed as a game-changer, by the end July 2018, Bayer Pharmaceuticals stated that it would stop selling the device by the end of the year. In September 2017, Bayer halted international sales of Essure, although the device will remain available in the U.S. until the end of 2018 as previously announced.
This major decision came after the FDA placed restrictions on the drug due to an onslaught of complaints of adverse effects related to the device. More than 25,000 complications were reported by thousands of users. Reported adverse effects included painful intercourse, pelvic discomfort, unwanted pregnancy, and painful menstruation, explain Cogan & Power, P.C. attorneys.
Bayer cited financial reasons and declining sales as the reason behind its decision to stop selling the device. Essure sales dropped by 70 percent in the U.S. after the FDA placed its restrictions on the drug, according to FDA Commissioner Scott Gottlieb’s July 20, 2018, statement. Additional FDA orders issued in April 2018 further restrict the drug by limiting sales of Essure to health care providers and facilities who adequately inform patients of the dangers and risks associated with the device.
Further complicating the matter, a huge percentage of complaints relate to the removal of the device, which means that women are placed in a catch twenty-two situation; both keeping the drug in place and removing it are considered as potentially risky.
Removal is considered a dangerous and complicated procedure which can cause the device to break apart and lodge pieces of the coil within the fallopian tubes, uterus, and vagina./44 In some cases, removal of the Essure device may require a full or partial hysterectomy. Of those who undergo surgery to have the device taken out, about 2.5% will require follow-up surgery within one year of the initial removal procedure.
In Bayer’s first-quarter 2018 earnings report, the pharmaceutical giant revealed it had been served with U.S. lawsuits representing approximately 16,800 users of Essure as of April 13, 2018. A surge of additional lawsuits in the U.S and internationally were expected.