Once hailed as the next great thing in female sterilization, Bayer’s Essure device will no longer be sold outside of the US, the company announced on Monday. It has been a turbulent time for the product, which is the only non-surgical form of permanent birth control, and the termination of non-US sales comes after years of questions over its long-term safety.
When Essure received FDA approval in 2002, its popularity grew rapidly in many countries as it offered a permanent, non-invasive solution and, crucially, could be inserted in the doctor’s office without the need for general anesthetic.
The high price of these micro-inserts compared to laparoscopic sterilization devices (such as tubal clips and rings) made Essure a valuable product, with a global market value of over $150M when acquired by Bayer in 2013. The product’s growth was steady at that time, driven by its popularity in the US, standing at approximately 4% year on year as calculated by GlobalData. Bayer indicate that over 750,000 women have undergone the procedure worldwide since it was launched in 2002. According to GlobalData estimates the US is responsible for approximately two-thirds of procedures, with around 100,000 taking place in 2016. France is comfortably the next largest market, with approximately 25,000 women undergoing the procedure last year.
The withdrawal of Essure from non-US markets follows a dramatic year for the embattled product. Anvisa, the regulatory agency of Brazil, suspended sales of the device in February 2017, citing product safety concerns. Since then, Bayer has ended distribution in Australia, Canada, Finland, the Netherlands, and the UK. Additionally, Essure’s CE mark was suspended last month due to unaddressed ‘queries associated with the recertification review’, temporarily halting sales across the EU as a whole.
Whether or not the safety concerns about the product are warranted, Bayer now has an image problem with Essure. The reputation of a medical device is always at risk when it becomes the center of negative mainstream media attention, impacting sales globally as both patients and physicians begin to shy away from the product. Indeed, key opinion leaders interviewed by GlobalData spoke to before Monday’s announcement indicated that sales of Essure were already decreasing.
Furthermore, while Bayer denies the validity of Essure’s safety concerns, withdrawing the product from six markets, including the major markets of Australia, Brazil, Canada, and the UK, is clearly not a good look. According to GlobalData, Australia, Brazil, and the UK round out the top five markets for Essure behind the US and France. However, with sales predominantly coming from the US, what happens in that market will be of the greatest concern to Bayer. As such, all eyes will be on the FDA over the upcoming months.
Having been notified of well over 10,000 instances of adverse events since the launch of Essure, the FDA applied a boxed warning—the strongest warning issued by the organization—to the device last year. Furthermore, Bayer reported involvement in US lawsuits related to the product from approximately 3,700 patients in its 2016 Annual Report. While the FDA still maintains that Essure is a safe and appropriate procedure for the majority of women, it also ordered Bayer to carry out a new post-market study into the possible long-term risks of Essure last year. Whether or not the FDA will take further action or Bayer decides that it is no longer financially beneficial to keep Essure on the market remains to be seen. According to Bayer’s 2016 Annual Report, impairment losses connected to the Essure device already cost the company €391M ($412M at the time of publication in February) last year.
It is unclear whether the cessation of non-US sales simply marks the first step in the complete withdrawal of Essure from the market, or if revenues from US sales are high enough to justify its continued availability to US physicians. Either way, the decision to keep the product on the US market must be weighed against the impact of global negative media attention, not just in terms of the inevitable increase in legal battles, but also dwindling sales resulting from declining physician confidence in Essure. GlobalData expects that the removal of Essure from all non-US markets and decreasing confidence in the US will result in increased global sales of tubal clips and rings, as well as a further increase in the use of long term reversible alternatives, such as interuterine devices/systems, as well as male contraception.