The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled. The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and […]
Essure
The top 5 MassDevice stories of the week — August 21, 2020
COVID-19 continues to dominate medical device industry news on MassDevice. The pandemic is causing more major lawsuit settling — as well as efforts to offer more medtech to enable better management of the coronavirus. Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly […]
BREAKING: Bayer settles 90% of Essure claims for $1.6B
Bayer (ETR:BAYN) announced today that settled approximately 90% of U.S. claims involving women alleging injuries related to its Essure device. Leverkusen, Germany-based Bayer reached agreements with plaintiff law firms on about 90% of the nearly 39,000 filed and unfiled U.S. Essure claims from women who allege device-related injuries, according to a news release. Settlements include all […]
Bayer sets aside nearly $1.4B for potential Essure settlements
Bayer (ETR:BAYN) during its second quarter ended June 30 set aside €1.245 billion ($1.39 billion), mainly to provide for potential lawsuit settlements related to its Essure permanent birth control device. Some of the provision was also for litigation defense costs and other pharmaceutical matters. As of July 24, Bayer faced U.S. lawsuits from roughly 32,000 Essure […]
Bayer failed to report Essure problems, lawsuit claims
Bayer (ETR:BAYN) failed to tell FDA about thousands of injury complaints related to its Essure contraceptive device, according to newly unsealed lawsuit documents reported by Bloomberg. The lawsuit documents out of California claim that the underreporting went back before Bayer acquired Essure maker Conceptus for $1.1 billion in 2013. Bayer responded to Bloomberg last week that […]
Essure study shows more pain, bleeding in women with implant
Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control. The FDA posted the results as part of a long-term safety evaluation of the device, which has […]
Bayer wins N.J. Essure case on appeal
A New Jersey appeals court has thrown out a woman’s product liability lawsuit against Bayer (ETR:BAYN) over its Essure permanent birth control device. Arcelia Sandobal Gomez had the Essure metal coils implanted in her fallopian tubes in 2014 and claimed she suffered intermittent and severe abdominal pain and chronic and abnormal vaginal bleeding afterwards. Gomez […]
Bayer loses Essure appeal in Indiana
An Indiana appeals court has ruled that more than 30 women suing Bayer (ETR:BAYN) over its Essure permanent birth control device may proceed with their case. The women claimed that after they had Essure implanted in their fallopian tubes, they suffered a number of health problems, including “menorrhagia, extreme fatigue, abdominal pain, back pain, joint […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]
Critic questions FDA’s handling of Essure product complaints
FDA continues to update how it is informing the public about the controversial Essure permanent birth control device from Bayer. But at least one prominent critic sees holes in FDA’s efforts. “Many women are still being implanted with the device without adequate warnings of the risks associated with the device,” attorney Holly Ennis wrote in an […]
