Dominoes continue to fall for Bayer, the German multinational healthcare company behind birth control implant Essure. Last week, we wrote about the corporation’s decision to discontinue sales of the controversial medical device, which tens of thousands of women say causes devastating side effects, in Finland and the Netherlands. Now, Bayer has confirmed in private correspondence that similar steps will be taken for the United Kingdom and Canada, with both sales and distribution of Essure in those markets expected to end in the near future.
“Change In Patient Demand”
Bayer has been quick to note that its recent decisions, which will see Essure disappear from four major commercial markets, are a matter of fiscal prudence, not an admission of the implant’s potential safety risks. In correspondence sent to the Toronto Star, the company wrote:
“In light of the change in patient demand, Bayer has decided to voluntarily discontinue the sale and distribution of Essure in Canada over the next few months. This decision was taken for commercial reasons, and the favourable benefit-risk profile of Essure remains unchanged. This is not a recall of the product from the market.”
No end date for Essure in Canada has been announced. The device’s withdrawal in the UK is set for September 1, 2017.
Falling Sales Lead To Essure Withdrawal
In both Canada and the United Kingdom, Essure is expected to remain licensed for sale. Likewise, doctors who are able to get their hands on the device will still be able to use it in their practices without fear of violating regulations. But no new implants will be entering the market, meaning the existing supply of the device will eventually dwindle to nothing. This, then, is the attenuated death of a medical device apparently deemed too unpopular to sell.
Women across the world have joined forces against Essure, denouncing the implant’s debilitating consequences and calling on global health regulators to step in. The movement, spearheaded by US group Essure Problems, has likely dealt irreparable damage to Bayer’s flagship permanent contraceptive, if not the company as a whole. No sales or implantation statistics have been made public, but it now seems undeniable that patients simply aren’t convinced by Bayer’s rhetoric around safety anymore.
Litigation Devalues Birth Control Implant
The wave of product liability lawsuits filed against Bayer couldn’t have helped, either. In the United States, over 1,000 women are suing the company, accusing corporate executives of concealing medical evidence from both the public and the medical community. Many of these patients have been forced to undergo invasive hysterectomy procedures that, in some cases, are the only solution to severe side effects. Still in its infancy, this growing litigation has already cost Bayer around $413 million in Essure’s value, according to Modern Healthcare. A lawsuit in Canada, now seeking certification as a class action, has attracted nearly 300 potential plaintiffs.
Only one country, Brazil, has instituted a full recall of Essure, with that country’s National Health Surveillance Agency noting in February that “technical-scientific reports” had shown the implant was too dangerous to remain on the market. The Food & Drug Administration, in contrast, has taken a less-aggressive stance, choosing to strengthen warning labels and mandate ongoing safety testing.
Notably, similar steps were taken by Canada’s national health regulator, Health Canada, over a year ago, after the safety watchdog conducted its own inquiry into reports of device side effects. Based on the investigation’s results, Health Canada informed physicians that Bayer would be made to come up with a black box warning and new patient information documents – measures identical to those required by the FDA. Apparently, declining sales have convinced Bayer that defending its product’s safety through contentious regulatory terrain isn’t worth it.
Will Bayer Pull Out Of Bigger Markets?
The Toronto Star says that around 8,000 Canadian women received Essure implants in 2016, which would represent about 1% of the 750,000 total devices Bayer claims have been used in clinical practice. These numbers, however, are highly-contested. As many public health advocates have pointed out, Bayer’s 750,000 number is plucked from Essure sales reports, not implantation statistics.
In reality, no one really knows how many patients have actually received the device. Notwithstanding these uncertainties, Canada is a relatively minor market for Bayer’s contraceptive implant. The United States is the company’s true money maker.