After years of controversy, Bayer has decided to stop selling its Essure birth control device in the US, equating the decision to a decline in sales.
Contraception
Even though the company is stopping sales of the device, Bayer is adamant that the decision is not related to the product’s safety and efficacy and instead references a number of factors that have contributed to declining sales in the US. The company mentions a decreased use of permanent contraception, increased reliance on other birth control methods and ‘inaccurate and misleading’ publicity about the device.
Despite Bayer referencing a body of research involving over 200,000 women over the past 20 years, a quick look at the company’s website highlights the problems women have experienced since having the device implanted.
For instance, a pre-marketing study of Essure referenced on Bayer’s website shows that 12.9% of women experienced mild to moderate pain, 29.6% experienced cramping, 6.8% experienced bleeding, and others experienced nausea, headaches and fainting. Further data shows that since the device’s approval date in 2002 and up until 2017, the FDA received 26,773 complaints related to Essure.
Last year, Bayer ended the sales of Essure outside of Europe and this latest decision finally puts the nail in the coffin for the controversial device.
Earlier this year, more pressure was placed on the device as the FDA restricted its sales in the US to healthcare providers that offered information to patients about its risks and benefits. Bayer stated that the impact of the restriction from the FDA resulted in a 70% decline in sales.
The controversy doesn’t stop there however and thousands of women have sued Bayer after experiencing life-changing side-effects as a result of the device including, pelvic pain, hair loss, damaged organs, hysterectomies and more.
The device, made of nickel and polyester (PET is placed into the fallopian tubes where is works “with your body to form a natural barrier that keeps sperm from reaching the eggs, preventing pregnancy”.
Bayer has said it will continue to enrol patients in a post-market surveillance study on Essure and will work with the FDA for future updates.
In its press release, Bayer says that it “remains strongly committed to women’s health where we have long been a leader. We recognise that women want safe and effective options that best meet their individual needs, and we are committed to continuing our investment, innovation and leadership in this important area of health”.