Bayer, the manufacturer of the controversial “permanent” birth control device Essure, announced on September 18 that it is discontinuing all sales and marketing efforts of the device in all European markets. Citing “commercial reasons,” the company continued to stand by the safety and efficacy of the device despite tens of thousands of reported injuries. The Essure device will remain on the market in the U.S. For now.
Bayer, the manufacturer of the controversial “permanent” birth control device Essure, announced on September 18 that it is discontinuing all sales and marketing efforts of the device in all European markets. Citing “commercial reasons,” the company continued to stand by the safety and efficacy of the device despite tens of thousands of reported injuries. The Essure device will remain on the market in the U.S. For now.
According to Le Monde, Bayer stated clearly that its decision has nothing to do with safety and that Essure’s supposedly positive benefit-risk profile “remains unchanged.” The FDA recently concurred with Bayer in the company’s assertion of that benefit-risk profile. However, it’s not hard to figure out that the “commercial reasons” cited by Bayer are declining sales and profitability.
How is it that sales of this device declined? It’s the author’s belief that grassroots efforts to tell the truth about this dangerous device have negatively impacted Bayer’s bottom line in the European markets. Since the company is inclined to put “profits over patients,” it’s no surprise that falling profits brought about the withdrawal of the device from those markets.
In fact, it appears that Bayer itself confirmed the author’s suspicions. According to Le Monde, in the same statement announcing Essure’s withdrawal, the company also said that it regrets that an “environment unfavorable” to this “innovative solution” for contraception resulted in a “continuous decline in demand in France.” As proof of “continuous decline,” one need only look at sales numbers. Resist, a French group working to have Essure removed from the market, provided Le Monde with sales data it obtained.
Bayer sold 28,000 Essure devices in France in 2015. That number fell to 21,538 in 2016, and took a huge dive down to 2,494 devices in the first four months of this year.
The E-Sisters, as women harmed by Essure call themselves, have powerful voices. The grassroots efforts that are negatively impacting Bayer’s bottom line and resulting in the company removing Essure from European markets, are the efforts of these brave women and their supporters. By telling their stories, lobbying lawmakers, and educating women who are considering getting Essure of the risks of that decision, the E-Sisters are doing the job of their respective governments because said governments won’t always do the work.
Nowhere is that truer than in the U.S., where the FDA has issued a black box warning advising patients of the risks, as well as provided a checklist that doctors should discuss with patients in order to obtain true informed consent. The FDA, despite its mandate of protecting citizens from danger, has no real power to force doctors to show patients the black box warning. Nor does the Agency have the power to enforce usage of the checklist. In fact, both actions are voluntary in the U.S. Not all doctors leave their patients in the dark, though. Dr. Julio Novoa, an outspoken advocate for the removal of Essure from the market, provided an excellent video discussing informed consent. Getting the truth out there about this dangerous device is vital to getting it pulled from the market everywhere.
The power of the people to effect change has been clear this year as Bayer removed Essure from several markets, always citing “commercial reasons.” The company voluntarily pulled the device in the Netherlands and Finland, as well as in Canada and the U.K. Then, the National Standards Authority of Ireland (NSAI), the agency responsible for approving Essure’s CE marking, the commercial license permitting the company to sell the device, issued a three-month ban on Essure sales pending a review of its safety before renewing the CE marking. Bayer’s recent decision to leave the European market entirely makes the CE marking renewal a moot point.
It’s said that “the pen is mightier than the sword,” and that “words have power.” If you have ever doubted this, Bayer’s announcement should provide proof that those sayings ring true. Without the unceasing hard work of the E-Sisters and their supporters, one has to wonder if such changes would have come to pass.
“What about the U.S.?” is a question frequently seen on social media. “When will the FDA stand up and protect us?” There is no immediate answer to either question, sadly. However, now is not the time for despair. The fact remains that Bayer cares more about money than people and, when money disappears, so does the company’s interest. This is not just in the European markets.
Bayer refuses to release U.S. sales data, so it’s hard to see the impact of the grassroots efforts here. Except when it isn’t… In a story titled “The Battle Over Essure,” published by The Washington Post in July of this year, the author, Jennifer Block, obtained some valuable information from Athenahealth, a medical billing management company.
In her story, Ms. Block wrote: “Sales of Essure among the 1,938 U.S. medical providers in its [Athenahealth’s] database who implant it have dropped by 70 percent since 2010.” Granted, that’s only one source and we have no way of knowing more concrete numbers. However, it seems fair to say that the E-Sisters’ public campaign to get this dangerous device off the market are negatively impacting sales in the U.S., too.
We can only hope that this downward trend in profitability continues. Since the government and the FDA seem unwilling to help, turning to the one language Bayer understands best – money – may be our best bet in finally banning Essure.
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