Multinational healthcare conglomerate Bayer has decided to withdraw its birth control implant Essure in Finland, according to a new press release published on the company’s foreign website. A similar market withdrawal is expected in the Netherlands, reports from Dutch medical sources suggest.
“Business Reasons” End Essure Sales In Finland
Bayer says the controversial device’s removal from the Finnish market comes down to “business reasons,” citing limited demand and a “continuous decline” in sales. A full stop to sales and distribution of Essure is expected on June 25, 2017. A screenshot of the announcement, captured on June 7 and translated from the original Finnish, is below:
As in previous announcements, Aino Försti-Smith, Communications Manager for Bayer Finland, doubles down on Bayer’s “commitment” to women’s health. Citing an “extensive clinical development program,” Försti-Smith describes Essure’s “positive” risk-benefit profile and promises to continue supporting current Essure patients and providers in Finland.
Update June 12, 2017 – Bayer Will Pull Essure From UK Market
Bayer’s Senior Medical Information Scientist Anuca Lofts has confirmed that the company intends to withdraw Essure from the United Kingdom on September 1, 2017, according to a report from Legal Reader. As with the medical device manufacturer’s announcement in Finland, Bayer is blaming the choice on financial losses: “Bayer UK would like to underline that this decision was taken for commercial reasons and that the favorable benefit-risk profile of Essure[…] remains unchanged.”
Will Market Forces Prove Essure’s Downfall?
Growing public pressure, along with the spreading knowledge of Essure’s potential side effects, is finally hitting Bayer where it counts. While the company refuses to release accurate sales data for the device, the market withdrawals in Finland and the Netherlands show that, globally, Bayer’s bottom line is suffering from its continued support of the birth control implant.
Direct action from health regulators, on the other hand, has been lacking. Currently, only one country, Brazil, has unilaterally issued an Essure recall.
Advocates Mock Bayer’s “Commitment” To Safety
Critics have lambasted Bayer for its characterization of the device’s approval process. While the company’s Finnish representatives seem satisfied with the results of clinical trials, many women can’t help but note the close ties between FDA reviewers who were instrumental in Essure’s approval and the company that initially developed the implant, Conceptus.
Holly Ennis, a member of the national advocacy group Essure Problems, points to Cindy Domecus, who served as Senior Vice President of Clinical Research and Regulatory Affairs at Conceptus for nine years.
Conflict Of Interest?
Active in the development of Essure, Domecus also served – at the same time – on the Food & Drug Administration’s Obstetrics and Gynecology Device Panel, a committee charged with reviewing the safety and efficacy of contraceptive devices. A device maker tapped to investigate the same devices from which she could profit? This seems the very definition of a “conflict of interest.”
Steven Bacich, the former CEO of Conceptus, even called Domecus out by name after Essure was designated for an expedited approval pathway. “It is the strength of the data […] and the expertise of Cindy Domecus and the entire regulatory and clinical research staffs in working together with the FDA,” Bacich said, “that enable us to pursue an accelerated regulatory time line.”
Reading that quote, it’s hard to tell whether Bacich is referring to Domecus in her position at Conceptus or her role as an FDA reviewer. That confusion is telling, but not entirely unexpected.
Netherlands Tapped For Next Market Withdrawal
Alongside Bayer’s decision in Finland, the Essure Problems Facebook group is abuzz with news that the company also plans to end distribution of its contraceptive implant in the Netherlands. Profit-driven motives, especially a recent decline in sales, are rumored to be the cause.
A 2016 estimate suggests that between 25,000 and 30,000 women in the Netherlands have received Essure implants since the device was first approved in the country around 2001. Ten years later, Essure’s original developer, a company named Conceptus, called the Netherlands its “third largest European country market” in a press release hosted on MedLatest.
Dutch Experts Note High Rate Of Removal Procedures
Dutch health regulators, however, have been worried about the potential dangers of Essure for quite some time. A 2016 report from the country’s National Institute for Public Health found that more than 1.5% of the Dutch women with Essure implants had reported side effects from the device. Chronic pain and fatigue were most common, followed by heavy bleeding and mood disorders.
Even more shocking, at least 16% of these women had already undergone removal procedures, hoping to end their debilitating symptoms. Another 36% had scheduled appointments to have the implants removed, the Dutch health regulator wrote.
Doctors Are Still Struggling To Help Patients
As we explained in an earlier article, removing Essure implants can be extraordinarily difficult. To date, only around 30 doctors in the United States can be considered “experienced” in removing the device. The problem has not been lost on Dutch doctors.
In 2016, a gynecologist from the University Medical Center of Utrecht, Bas Verseema, bemoaned the lack of adequate training for health care providers attempting to remove Essure implants. “The training of gynecologists is sorely needed,” Verseema told EenVandaag Gezondheid, “because the springs can break when removed.”
While Verseema remained hopeful about the device’s benefits for patients, the rising number of side effect reports had him worried: “if the group of women with complaints is too great – which we cannot explain [other than with] the presence of the [implants] – then we have a problem.” At the time, Verseema had already removed Essure implants from around 100 of his patients.