Earlier this month, Bayer took the unusual step of halting sales of Essure, one of its previously best-selling birth control solutions, in all countries outside the United States.
Essure, is a permanent birth control solution that does not require surgery or anesthesia. Since its debut in 2002, more than 750,000 women worldwide have opted to use Essure despite mounting evidence of serious risks involved.
In a press release on its French-language website, Bayer said the move was not related to the product’s safety or quality. Instead, the company decided to halt sales because of “commercial reasons.”
“An environment unfavorable to its prescription” has been in place for several months leading to a “continuous decline in demand,” the company stated in the press release.
This permanent birth control device consists of two 1.5-inch metal coils that are inserted through the vagina into the fallopian tubes. Once in place, the coils induce scarring in the fallopian tubes that block eggs from descending from the ovaries into the uterus, preventing fertilization.
Earlier this year, it was announced that Essure would be removed from markets in Brazil, Finland, and the Netherlands. It is still available in the United States despite several women’s groups calling for a ban.
Why Hasn’t the FDA Taken Action?
The halting of sales outside the United States begs the question of why the U.S. Food and Drug Administration (FDA) has not already taken stronger action. The agency has said it will continue to monitor the safety of Essure, but for now, believes the “benefits of the device outweigh the risks.”
The FDA in 2016 directed that a black box warning must go on Essure packaging. The agency worked with Bayer to create a checklist for doctors to review with their patients before implanting Essure, stipulating key information about the device, its use, its effectiveness, and its risks.
Over the years, the FDA has received several reports of problems with Essure, including reports of persistent pain, perforation of the uterus and fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergic or hypersensitive reactions. Some women have had surgery to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.
The move by Bayer puts Essure into a select category of FDA-approved products that are available in the United States, but off the market most everywhere else.
A 2012 study by the Temple University School of Pharmacy found significant differences in the way the FDA bans a product, compared to other countries’ regulatory bodies. Of 151 single-component pharmaceuticals listed in a United Nations’ Banned Drug list, the researchers discovered that 17 percent of them were banned internationally, but available in the United States. On the other hand, only 9 percent of the drugs were banned in the United States, but available in other countries.
Among the drugs noted in the study was Avandia, a controversial anti-diabetes drug that remains on the market in the United States.
Avandia, also known as rosiglitazone, once brought in annual sales peaking at $2.5 billion for GlaxoSmithKline in 2006. However, a study in the New England Journal of Medicine in 2007 linked the drug to an increased risk of heart attack. It was subsequently banned in Europe and withdrawn from markets in the UK, Spain, India, New Zealand, and South Africa. Sales plummeted to $9.5 million in 2012.
Despite the actions of regulatory bodies in other countries, in 2013 the FDA actually removed some restrictions it had earlier placed on rosiglitazone citing a 2009 study that apparently failed to demonstrate an increased risk of heart attack when using the drug.
Another drug that remains in wide use in the U.S. while being banned elsewhere is the muscle relaxant, carisoprodol, also known as Soma.
The European Medicines Agency recommended the suspension of Soma in 2007 following the publication of a Norwegian study that demonstrated an elevated risk of abuse and addiction associated with the drug. Authorities in Norway, Sweden, and Indonesia pulled the product from their markets. The UK also removed the product from the market there due to increased risk of abuse, addiction, and impairment.
The drug remains available in the United States as a Schedule IV controlled substance.
As for Essure, advocacy groups continue to call on the FDA to ban the device outright.