Product News and Recalls

Essure No Longer Available…Except in the United States

essure now only available in united statesAcknowledging a global decline in demand for its Essure contraceptive device, Bayer announced last week that it was pulling the device off the market around the world – except for the United States. In the same statement, the medical manufacturing giant sought to assure the public that the decision was “not linked to a safety or product quality problem.”

Tens of thousands of women in the U.S. and around the world would likely take exception to such a statement. In fact, Essure has been mired in controversy almost since the day it was released.

Essure works by stimulating the formation of scar tissue to block the fallopian tubes. Over time, the tubes completely close, effectively making the woman infertile. It is marketed as a simple, painless, non-hormonal way of ensuring virtually no risk of pregnancy.

The reality, however, is another story. Complaints range in severity from device migration to other organs in the body, perforation of those organs, and unbearable pain and bleeding, which was in some cases linked to life-threatening injuries.

Women around the U.S. rallied, hoping their legislators would take action or the FDA would investigate. Although Congress appeared to be moved to some sort of action and investigation, the FDA appeared to be largely unconcerned. It wasn’t until early 2016 that the device was finally given a black box warning. No recall action was discussed however, and the agency was careful to leave protections in place for Bayer that made legal action against the pharmaceutical titan difficult, if not impossible.

Those protections were finally removed in the summer of 2016; not by the agency sworn to watch over the food and drugs ingested by the American public, but by a Superior Court judge in California. Essure plaintiffs would finally have their chance to make their cases, injuries, and horrors known.

Bayer’s decision to stop selling Essure in every country except for the United States could very well be a commercial decision. After all, the market is dictated by demand. And if almost every country in the world has said that they don’t want your product, then the sensible decision is to stop selling that product.

But tens of thousands have also made their views known in the last remaining country to carry the device. And what the FDA will allow, Bayer is more than happy to exploit.