Essure birth control device may lead to complications
On February 29, 2016, the U.S. Food and Drug Administration said it will require German drugmaker Bayer AG to undertake new safety studies on its permanent birth-control device Essure, after thousands of women complained about suffering complications from the controversial implant, including pain, bleeding and allergic reactions.
Essure will now also need to be labeled with a stronger warning that lists potentially serious risks of the device, and doctors will be encouraged to discuss a checklist of potential risks with patients.
What is Essure?
Essure is a permanent, irreversible form of birth control intended for women who don’t want any more children. Since its introduction in 2002, about 750,000 women have received Essure, according to Bayer.
How does Essure work?
Unlike the traditional method of female sterilization, known as tubal ligation or “getting your tubes tied,” implanting Essure doesn’t require surgical incisions. Instead, a doctor can insert the implant through a woman’s vagina, past her cervix and into the fallopian tubes. Over time, scar tissue builds up around the insert, forming a barrier that prevents sperm from reaching eggs in the fallopian tubes.
Why is the FDA acting now on Essure?
This recent action on Essure comes after the FDA received more than 5,000 reports of complications from the device, including chronic pain and bleeding. Also, because part of the device is made from a nickel-titanium alloy, patients with a nickel allergy may have a reaction to the device, including rash, itching and hives.
From the FDA statement: “While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications. These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.”
What are my legal rights if I’m an Essure patient?
You should contact an experienced medical device attorney to review your rights.
Ashcraft & Gerel is investigating possible lawsuits against the makers of Essure. Our experienced attorneys have successfully handled many similar cases in the past related to dangerous pharmaceutical and medical devices. Please contact us online or call us at 800-829-7037 to speak with an attorney today. All consultations are free and completely confidential.