COMMENT: Regional

With only the US market left, can Bayer’s Essure device survive?

​​​​​​​The withdrawal of Bayer’s Essure sterilisation device from non-US markets has caused speculation over the product’s long-term future as safety concerns and lawsuits mount.

Once hailed as the next great thing in female sterilisation, Bayer’s Essure device will no longer be sold outside of the US, the company announced in September.

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 anaesthetic.

The high price of these micro-inserts compared to laparoscopic sterilisation 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.

According to Bayer more than 750,000 women have undergone the procedure worldwide since it was launched in 2002. According to GlobalData estimates, the US accounts for around two thirds of procedures, with around 100,000 taking place in 2016. France is the next largest market, with some 25,000 women undergoing the procedure last year.

Market withdrawals amid safety concerns

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.

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 centre of negative mainstream media attention, impacting sales globally as both patients and physicians begin to shy away from the product.

Whether or not the safety concerns about the product are warranted, Bayer now has an image problem with Essure.

Key opinion leaders interviewed by GlobalData before Bayer’s announcement indicated that sales of Essure were already decreasing.

Furthermore, while Bayer denies the validity of these safety concerns, withdrawing Essure from six markets, including the major markets of Australia, Brazil, Canada, and the UK, clearly does not look good. 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.

Essure’s future in the US

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 organisation – 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 the product 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 $412m in 2016 (at the time of the report’s publication in February).

It is unclear whether the cessation of non-US sales marks the first step in the complete withdrawal of Essure from the market, or 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.

It is unclear whether the cessation of non-US sales marks the first step in the complete withdrawal of Essure from the market.