Bayer halts sales of Essure outside US

Bayer (ETR:BAYN) said today it is halting sales of its Essure contraceptive device outside the US in response to “commercial reasons” and not due to safety or product quality issues. 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,” according 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 rel...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Women's Health Bayer Source Type: news