This week, Bayer released their annual report and incurred a $413M loss due to Essure injuries. Almost 10,000 women filed complaints with the FDA due to horrific side effects they experienced when using the device. This led to thousands of lawsuits against the manufacturer. Yet, Bayer stands by the efficacy of the product regardless of the black box warning in the US and Canada, or news that Brazil just banned the intrauterine device.
What is Essure?
Essure is a soft, flexible metal spring made from a nickel-titanium alloy. Doctors offer it to women as an alternative to the invasiveness of tubal ligation. Essure typically involves general anesthesia and a laparoscopy in the doctor’s office unlike a tubal ligation, which occurs in a hospital and requires surgery. A doctor inserts one Essure coil into each fallopian tube. Scar tissue will form around the coil to obstruct sperm from fertilizing an egg in the fallopian tubes. Three months after the procedure, women must have a follow-up procedure involving an X-ray and dye to confirm that the tubes are fully blocked.
Bayer, the manufacturer of Essure, claims it is nearly 100 percent effective at preventing pregnant and is perfecting safe; however, thousands of women disagree.
Essure Complications
The FDA fast-tracked approval of Essure in 2002 with the requirement that researchers will monitor patients in the initial study for an additional 5 years. Regrettably, researchers followed only 366 of the original 618 patients. Out of those 366, 15 had hysterectomies, 38% had usually heavy periods, 5% suffered from recurrent pelvic pain and 4% painful intercourse.
Higher Surgery Risk
Moreover, the British Medical Journal published a study in 2015 linking Essure with a 10-fold risk of needing follow-up surgery compared to tubal ligation. Researchers based their conclusions on an analysis of over 50,000 women in New York. Doctors sterilized these women between 2005 and 2013. During this time, 2.4% of Essure users needed additional surgery versus 0.2% of those who had laparoscopic sterilization. Additionally, this equaled to about 10,000 women needing additional surgery after having Essure.
Essure Injuries Bring Lawsuits
When Bayer released their annual report, they acknowledged the growing number of lawsuits. The report stated approximately 3,700 users filed against them as of Jan. 23, 2017. It also mentions the possibility of more coming.
“Plaintiffs allege personal injuries from the use of Essure, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy,” the annual report said. “Additional lawsuits are anticipated… Bayer believes it has meritorious defenses and intends to defend itself vigorously.”
Even in their annual reports, Bayer still denies culpability. It is unclear if Essure’s revenues, sales, and distribution have declined due to injuries associated with the device.
If you suffered after a doctor implanted Essure, please speak to us to learn more about your rights. The Michael Brady Lynch Firm is currently accepting cases in all 50 state. Please use the form on this page or call toll-free 24 hours a day at 877-513-9517.