The US Food and Drug Administration (FDA) has restricted the sale and distribution of Bayer’s Essure permanent contraception device.
The decision was taken because some women were not being adequately communicated of Essure’s risks before getting the device implanted.
The regulator said that there has been an around 70% decline in sales of Essure in the US, since its order of conducting a post-market study and add boxed warning, as well as patient decision checklist to the labeling.
It also concluded that some women still are not receiving information about the known risks associated with Essure device before implantation.
The new Essure labeling is said to limit the sale and distribution of the device to only health care providers and facilities, which offer information to patients about the risks and benefits of the device.
Essure is claimed to be the only permanently implanted birth control device for women on the market, which does not need a surgical incision.
The procedure involves the insertion of flexible coils through the vagina and cervix and into the fallopian tubes. Tissues forms around the inserts over a period of approximately three months.
The developed tissue forms a barrier that keeps sperm from reaching the eggs, enabling to prevent conception.
Since the device’s approval in 2002, the FDA has continued to monitor the product’s safety and effectiveness by assessing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency.
Based on the assessment, the regulator ordered Bayer to carry out a post-marketing (522) study to better study the safety profile of the device when used in the real time.
FDA Commissioner Scott Gottlieb said: “We take the concerns of all women affected by Essure very seriously.
“I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information.”
Image: The FDA campus at New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.