Update: The FDA has instructed Bayer to conduct further studies regarding Essure. At least one of the studies must provide information on the real world risk of using the birth control device. The FDA also issued a checklist for doctors to use when discussing the risks associated with Essure.
Essure is a permanent form of birth control that doesn’t require surgery. The Essure website reports approximately 750,000 women currently or have previously used the product.
The device is made of metal coils and plastic fibers that doctors insert into each fallopian tube.
The Food and Drug Administration has been reviewing negative reports associated with Essure for the past several years. Some of the reports list problems like persistent pain, perforation of the uterus/fallopian tubes, and abnormal or irregular bleeding.
Doctors, patients and the Essure manufacturer have all reported on the product in the 10 years since it came on the market. There have been 5,093 reports on Essure, the majority of which were received after 2013, according to FDA.gov.
Reports of death were confirmed; however, the FDA website also states that six of the reports listed death when no death occurred. Additionally, five reports listed fetal death in women who became pregnant following the placement of Essure.
Madris Tomes, founder and CEO of Device Events, says analysis of the negative effects from Essure show 303 fetal deaths related to the device, Reuters reported.
“It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term,” Bayer, the manufacturer of Essure, said in a statement to Drugwatch.com.
Women who’ve had adverse effects to the device call themselves E-sisters. There are support groups on Facebook in various states, including Texas, for E-sisters.
Five women filed product liability lawsuits against Bayer Healthcare in relation to Essure as of July according to Modernhealthcare.com.
The FDA stated it would release a public report related to Essure at the end of February. At the time of publication of this article, no public report was available.