Pharmaceutical manufacturer Bayer will stop selling and distributing the Essure permanent contraceptive device in the United States after December 31st, 2018, the company announced last week.
The product is the only permanent non-surgical form of birth control available in the US and is estimated to have been used by more than 750,000 women worldwide. Fitting of the Essure is via a minimally invasive procedure in which the device is inserted into the fallopian tubes, where scar tissue builds around it, blocking the passage of the sperm to the eggs.
Alternative forms of birth control include contraceptive implants and injections, monophasic contraceptives such as Ocella (drospirenone and ethinyl estradiol) biphasic contraceptives, triphasic contraceptives, extended cycle contraceptives and progestogen-only contraceptives, for example, Nora-Be (norethindrone) or Depo-Provera (medroxyprogesterone).
Since its initial approval in 2002, the US Food and Drug Administration (FDA) has continued to monitor the safety and effectiveness of the Essure device, reviewing medical literature, clinical trials and the data from a post-approval study. However, reports of serious adverse events associated with the device, including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the abdomen or pelvis, prompted the FDA to take action in recent years.
In February 2016, the FDA ordered Bayer to conduct a post-market (522) study to evaluate the safety profile of the device when used in the real world and announced its intention to require labeling changes to improve patient understanding of the device. In April 2018, the agency restricted sale and distribution of the device in an effort to address concerns patients were not all receiving the appropriate risk information.
Bayer announced that the decision to discontinue sales of the device taken for commercial reasons, following a 70 percent decline in sales of the Essure in the United States since the FDA required the company to conduct a post-market study and add a boxed warning with Patient Decision Checklist to the labeling "The benefit-risk profile of Essure has not changed, and we continue to stand behind the product's safety and efficacy, which are demonstrated by an extensive body of research," Bayer said.
The company attributed the decline in sales to a decrease in permanent contraception use, increased use of alternative birth control options, and “inaccurate and misleading publicity about the device”.
Despite Bayer’s decision to discontinue use and distribution of the device in the United States, FDA Commissioner Scott Gottlieb, MD, reassured patients who already have the device that the agency will continue to monitor the product and communicate any further findings or concerns. Women successfully using Essure to prevent pregnancy should continue to do so, but should discuss any symptoms they are concerned may be related to the device with their healthcare professional, Gottlieb added.