FDA Says Essure Birth Control Devices Were Linked to 15000 Adverse Reports in 2019
The U.S. Food and Drug Administration (FDA) on April 24th released data from more than 15,000 new adverse event reports in 2019 regarding Essure birth control devices. According to the report, the most common reports involved surgery to remove the Essure device, chronic pain and menstrual irregularities. Essure has consistently had problems over the last 17 years.
What is Essure?
Essure is a medical device that is inserted into a woman’s reproductive system where it triggers the growth of scar tissue that then seals off the fallopian tubes and prevents pregnancy. Bayer advertised Essure as a quick and safe way for women to avoid pregnancy without going through a traditional tubal ligation surgery that requires general anesthesia.
According to the FDA, overall, there have been 47,856 reports of adverse events from the time Essure was approved in 2012 through 2019. Around 90% of those reports involve the device’s removal. From 2012 to 2019, the most frequently reported side effects patients said they suffered were abdominal pain, heavier periods, menstrual irregularities, headaches, organ perforation, fatigue, weight fluctuations, depression and anxiety, and hair loss.
The most frequent device problems were metal allergies among patients, device breakage or fragmentation, dislodged/dislocated device and difficulty removing the device. In some cases, the devices did not work as intended and resulted in unwanted pregnancies.
Bayer is now facing nearly 20,000 lawsuits nationally from women who suffered severe and life-changing complications. In many cases, the women had to undergo surgeries, sometimes even multiple surgeries, to get the device removed. In 2017, Essure was recalled in most countries around the world, but Bayer continued to sell it in the United States until voluntarily pulling it off the market in December 2018 citing declining sales.
Even though Essure is not on the market, more than 500,000 women have been implanted with this device and tens of thousands are developing long-term complications. The Essure Problems public Facebook group has nearly 47,000 members. Social media and online spaces have become places where women affected by these defective products have gathered to share their stories.
If you or a loved one has suffered these types of side effects due to this medical device other devices, you may be able to seek compensation for your losses including medical expenses, lost income, hospitalization, permanent injuries, disabilities, pain and suffering and emotional distress. An experienced product defect lawyer will be able to advise victims and their families regarding their legal rights and options.