Essure contraceptive implants. Bayer withdraws the product "for commercial reasons" in the USA
Already prohibited in Europe, it had ended in the storm in recent years due to the alleged serious side effects consisting of "perforation of the tubes and uterus"
After being repeatedly accused of adverse reactions in several countries around the globe, the Essure permanent contraceptive device, developed by Conceptus Inc., a subsidiary of Bayer, at the end of the year the device will no longer be marketed in the USA, after one similar stop in Europe last year. The initiative was confirmed by the authoritative Food and Drug Administration (FDA), the US government agency that deals with the regulation of food and pharmaceutical products, which received notification from Bayer that the Essure permanent contraceptive device will no longer come released in the US after December 31, Scott Gottlieb, the director of the institution, commented in a statement that: "The decision follows a series of actions that the FDA had taken following the reports of adverse events associated with the use" . In the United States, civil rights activist Erin Brockovich has started a long battle to get the Essure out of the market, and now runs a website where women implanted with this contraceptive method can tell their stories and share their stories. experiences. Thousands of women have in fact complained of serious side effects such as organ perforation caused by the fragmentation of the micro-inserts, which in many cases required the surgical removal of the device. Available in France since 2002, it has been placed under enhanced surveillance in 2015 by the National Agency for the Safety of Medicines and Health Products (ANSM), due to an increase in reports of adverse effects. According to an ANSM study, the Essure compared to the other sterilization method, the tubal ligation, with minimally invasive surgery, does not have a "higher overall risk". At the end of April 2017, a committee of independent experts appointed by ANSM felt the need to improve information for patients in this device, but did not consider it necessary to limit its use. Judicial proceedings are already pending before the Bobigny court, which gave the go-ahead in April for requests for advice from three female carriers or former carriers of the facility. Since 2001, approximately 1 million units of the Essure medical device have been sold worldwide, including 240.000 in France, according to Bayer's laboratory. In Brazil, the National Health Surveillance Agency has ordered the recall of the sterilization plant and the suspension of its sale, distribution and use, claiming serious side effects of the device. Bayer alone in the United States has received several thousand cases concerning the serious side effects of Essure, from perforation of the fallopian tubes and uterus to bleeding, so much so that a Netflix documentary on the matter is on the way. According to the company, however, behind the withdrawal there are only commercial reasons, starting from the strong slowdown in sales also due to the controversy. "We want to reassure patients who use Essure and their doctors that the decision was made for commercial reasons - Bayer writes - and that it is not related to safety or quality problems". In Italy, Essure, which should be remembered was a permanent and irreversible contraceptive method, is 100% reimbursed by the National Health Service. The procedure that could be performed in a hospital or clinic in less than 10 minutes therefore had wide diffusion among all those women who chose the path of sterilization.
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