Bayer (ETR:BAYN) last week fired back against claims that its Essure permanent birth control device is less than safe and effective after having announced plans to pull the device from the shelves in the US a week earlier.
Last Thursday, the pharmaceutical giant published a press release lauding the device as the only FDA-approved non-incisional form of permanent birth control and reiterating the its safety profile “remains positive and unchanged.”
Bayer suggested that there is “no reliable scientific evidence” suggesting its Essure isn’t safe, and said that recent concerns were merely “based on anecdotal reports, rather than science.”
“While Bayer takes any adverse event report seriously, the FDA has repeatedly cautioned that adverse event reports can be ‘incomplete, inaccurate, untimely, unverified or biased’ and duplicative, and that adverse event reports alone cannot be used to determine rates of events or causation. Indeed, in 2015 FDA reviewed the safety data for Essure and did not identify new safety or efficacy concerns,” Bayer wrote in a press release.
The company also expressed concerns about “the ongoing public promotion of Essure removal” as well as “inaccurate or misleading information spread by third parties” that would suggest the use of hysterectomies as a solution to issues with the Essure implant. Bayer said that its instructions for use state that “hysterectomy generally is not required to remove the Essure inserts,” according to the press release.
The release pre-empted the posting of a CNN report claiming that the company made $2.5 million in legal, but controversial, payments to doctors between 2013 and 2017 related to Essure consulting fees and other services, as well as the posting of a Netflix documentary critical of the medical device industry with a specific focus on Essure patients.
