Category: Conceptus Inc.
Bayer Healthcare cites 5-year data from a study of its Essure device as confirming the safety and effectiveness of the female sterilization procedure.
Here's a look at some of the top regulatory stories for medical device companies this week: Olympus sold 'superbug' scopes without our clearance; FDA clears 1 Hospira plant, flags another; GI Dynamics plunges 50% after FDA halts trial; Sunshine Heart stops trial enrollment after patient deaths; Petition accuses Bayer's Conceptus of altering Essure trial data
A citizens petition filed last month with the FDA accuses Bayer subsidiary Conceptus of altering the clinical trial data for its Essure female sterilization device to win pre-market approval from the safety watchdog.
UPDATED March 10, 2015, with comment from Bayer.
Dr. Charles Carignan, the former CEO of Ninepoint Medical, joins BiOM as its next CEO.
BiOM has named Dr. Charles Carignan as its next CEO, replacing Tim McCarthy, who left the company this past spring.
Carignan is a 20-year medtech veteran who has held several key positions in the medical device industry, including most recently at NinePoint Medical, where he was the founder and CEO.
Women rallying against the Essure contraceptive implant are congregating online and picketing on street corners, calling on Bayer to recall the device.
MASSDEVICE ON CALL — The anti-Essure movement, launched by women who claim the permanent contraceptive implant left them with severe pain and injuries, doesn't look likely to die down, having spawned Facebook support pages, Twitter campaigns and lots of media attention.
The movement has attached itself to the Twitter hashtag '#EssureRally', through which women are calling on Bayer to recall the device, posting pictures of the ralliers in action and organizing real-world events, including street-corner picketing and conference calls with famed consumer advocate Erin Brockovich.
GlobalData analyst Joseph Gregory says public advocate Erin Brockovich's patient safety claims against Bayer's Essure contraceptive implant are "inappropriate" and "unsubstantiated."
The FDA says its additional review suggests Bayer's Essure permanent birth control device isn't connected to rising patient reports of post-treatment weight-gain, depression and fatigue.
It looks like healthcare giant Bayer (PINK:BAYRY) has got the FDA in its corner against a rising tide of patient complaints over the company's Essure permanent birth control device.