On February 17 of this year, the Brazilian health authority Anvisa announced that all imports, distribution and sales of the Essure contraceptive device would be discontinued in that country.
Essure has been classified as being of “maximum risk” because of “changes in menstrual bleeding, unwanted pregnancy, chronic pain, perforation and migration of the device, allergy and sensitivity or immune-type reactions.” This month, Bayer AG announced its decision to discontinue Essure marketing and sales in Finland and the U.K., citing declining sales figures. Essure distribution will cease in Finland on June 25th, and will no longer be available in the U.K. after September 1st.
According to the Bayer AG website (translated from Suomi):
“Bayer has decided to close Essure® preparations from the sales and distribution in Finland 06/25/2017 business reasons. The demand for Essure® preparations in Finland has been limited and in continuous decline, and there is no expected change in the situation.”
In other words, it has nothing to do with safety concerns and everything to do with the fact that Bayer isn’t making any money from a device that is causing severe injuries and doesn’t function as advertised.
In response to a recent inquiry, Bayer UK confirmed its plans to “discontinue the sales and distribution of Essure in the UK from the 1st [of] September 2017.” Tellingly, Bayer emphasizes that the decision “was taken for commercial reasons and that the favorable benefit-risk profile of Essure remains unchanged” (emphasis mine).
As is the case in the company’s other decision, none of the stories of women suffering as a result of Essure or the lawsuits facing the company have any impact on Bayer’s marketing decisions – it’s all about profits (or in this case, the lack thereof).
Significantly, when Brazilian health authorities took action to ban Essure sales in their country, there was push back from Bayer. At the time, the company issued a statement: “We disagree with the decision by health regulators in Brazil which was taken without the knowledge of Bayer.” They added that they were attempting to work with Brazilian health regulators in order to “fully understand the decision” and continued to insist on the “safety and efficacy of which is supported by clinical trials and more than a decade of science and real world clinical experience worldwide.”
Bayer cited a paper published in the New England Journal of Medicine in October of 2015, in which the authors wrote “The device offers clear advantages,” but also references the high number and nature of adverse events associated with Essure, pointing out that “problems with the device’s effectiveness, might have been detected sooner or avoided altogether if there had been higher-quality premarketing and post-marketing evaluations and more timely and transparent dissemination of study results.”
Meanwhile, here in the U.S., the Food and Drug Administration has taken virtually no action toward removing Essure from the market, despite the large number of adverse event reports. In 2015, Representative Michael Fitzpatrick (R-PA) introduced legislation to outlaw Essure sales, and the bill has garnered bipartisan support. Other bills introduced by Fitzpatrick include “Ariel Grace’s Law” (H.R. 5403) and the Medical Device Guardians Act (H.R. 5405), both of which were introduced last year. The latter two bills are more general in nature, but would have impacts on Essure and other harmful medical devices in terms of holding manufacturers and physicians accountable. Unfortunately, no further action has been taken on these bills.
In the end, the only way to rid the U.S. of Essure may be for patients to follow the examples of patients in Finland and the U.K. and just stop using it – since a profit and loss statement is the only thing Bayer understands.