Bayer is set to end Essure sales and distribution across the world, except in the United States.
By Laurence Banville
Multinational healthcare giant Bayer has announced that its controversial birth control implant Essure will no longer be available outside of the United States. Citing a steep decline in global demand, a press release issued on Monday, September 18, 2017 said that Essure distribution and sales would be ended immediately in every country except for the US.
Decline In Demand Blamed For Essure Demise"We would like to reassure Essure patients and their accompanying healthcare professionals," the company wrote in a statement published on its website, "that this decision is made for commercial reasons and that it is not related to a safety or product quality issue." Instead, Bayer says, "an environment unfavorable to [Essure's] prescription" has taken hold across the world, leading to "a continuous decline in demand."
Global Protest MovementWhile Bayer only gestures briefly to the global protest movement that sprang up to combat Essure-linked side effects, it's close to certain that any "environment unfavorable" to Essure should be attributed to the efforts of thousands of public health advocates in over 13 countries who say the implant is unreasonably dangerous.
Bayer's move has been hailed as an astonishing triumph for hundreds of thousands of women around the world, both those searching for safe and effective contraception and those who believe Essure caused them to suffer severe harm. In the United States, thousands of injured patients and their loved ones have filed suit against Bayer, accusing the company of exploiting Food & Drug Administration protections to foist a dangerous medical device off on unsuspecting women. Essure's severe side effects are now well-documented.
15,000 Side Effect ReportsIn more than 15,000 FDA adverse event reports, patients and medical providers link the birth control implant to chronic pain, abnormal menstruation patterns, fatigue, cognitive impairments and even autoimmune disorders, CBS News reports. A number of prominent medical studies have also called the device's efficacy into question, arguing that real-world pregnancy rates may be far higher than advertised by Bayer.
Nations Push Back Against BayerNeedless to say, Bayer maintains that its global market withdrawal has nothing to do with Essure's safety or efficacy. And while it's plausible that Bayer's decision comes as a direct result of market forces, it's also indisputable that government health regulators around the globe have taken note of Essure's dubious safety profile.
The European Union failed to renew the implant's commercial license after officials from the National Standards Authority of Ireland demanded more evidence on safety testing.
That move ended Essure distribution throughout the European Union's 28 member states, but even before then, Bayer had begun pulling the implant out of lucrative markets. In June 2017, the company ended distribution and sales in Canada, the United Kingdom, Finland and the Netherlands. Meanwhile, Brazil's national health regulator issued a unilateral Essure recall.
Now, this piecemeal approach to withdrawal has ended, with Essure available in only one of the world's markets, the United States.