2016 was a banner year for Bayer AG, according to its annual report to stockholders. Last year, the German-based company’s net income from all sources was $4.8 billion, an increase of nearly 9% over the previous year. Much of that came from Bayer’s pharmaceutical division, which posted earnings of $3.58 billion. However, legal action over the Essure contraceptive device and falling sales figures cost Bayer $413 million over the same period.
To date, there have been 10,000 adverse events reported to the FDA and more than 3,700 lawsuits filed against Bayer, alleging that the Essure device was responsible for injuries ranging from weight gain and unexpected pregnancies to chronic pain, severe allergic and auto-immune reactions and serious bleeding.
Although Bayer carries insurance covering them for “statutory product liability claims,” the company’s liability relating to Essure and the contraceptive pill Yasmin has exceeded their coverage limits. Bayer is expecting that additional lawsuits will be filed, but continues to stand by the product. In the report, Bayer states “…it believes it has meritorious defenses and intends to defend itself vigorously.”
Meanwhile, sales of Essure have been on the decline. Dr. James Greenberg of Boston’s Brigham-Faulkner OB/GYN Associates, said he would be “surprised” if any of his patients had received Essure over the past 12 months. For several years after Essure was approved by the FDA, Greenberg was implanting an average of thirty devices every year. When lawsuits started being filed, that demand fell off sharply.
Greenberg points out that these days, patients are doing more research before consenting to new procedures and treatments. “I think the average medical consumer today goes right to the web,” he said. “You put in Essure, and the first thing that comes up is lawsuits. That’s not something that makes you super excited to have that done to you.”
A recent survey of nearly 400 women’s doctors across the country showed a definite fall in the number of Essure devices being implanted. Most of the 270 who said they had implanted patients with Essure said the number of those devices being used had declined over the past five years. Brazil’s National Health Surveillance Agency has stopped supplying Essure to women patients and has had all such devices recalled.
Another factor that may be contributing to the demise of Essure is competition from other, safer and proven forms of birth control, particularly reversible ones such as IUDs and hormonal implants.