The company said it originally announced it would pull the device from the shelves in most countries in May, and added that it will not resume commercialization in the European Union with no plans to renew its CE Mark.
Bayer said it has seen a decline in demand, with a specific drop in France, after the CE Mark for Essure was temporarily suspended in August, according to a French press release.
The company went on to again reinforce that the withdrawal from the market was a result of commercial challenges and not health or safety, saying that the device’s positive benefit-risk profile “remains unchanged,” to the press release.
Bayer said it will continue to market Essure in the US, where it said the FDA had recently evaluated it and found a favorable risk-benefit profile for the device.
Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said in 2015 that it received 5,093 complaints in the 13 years since Essure’s approval, including for pain or menstrual irregularities after using the device and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said.
In November 2016, the federal safety watchdog released new labeling requirements for Essure other permanent hysteroscopically-placed tubal sterilization implants. The updated guidelines mandated a patient checklist to avoid possible adverse events and a boxed warning as labeling for the devices. The FDA last year mandated a new study and new labeling of Essure. In August 2016, the agency said it completed a review of a trade complaint which alleged that Bayer was engaged in clinical trial misconduct and altering data, finding no signs of manipulation.
In July, a federal judge in Missouri cut 86 of the 94 plaintiffs from a group of consolidated lawsuits filed against Bayer over the Essure device.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.