There are many birth control options for women. Finding the safest and most effective treatment relies on several factors such as your tolerance for the pill and how long you’d like to be on a contraceptive. Essure is an implanted device that’s placed in the fallopian tubes to prevent pregnancy by blocking the opening. Informed consent is an essential part of this decision just as it is for all pharmaceutical drugs, procedures, and treatments.
The makers of Essure, Bayer and Conceptus, are facing legal action because of defective medical device claims that women weren’t aware of the risks when they agreed to try the implanted device and suffered greatly after the spring-like device broke apart and moved through their bodies, causing significant harm to the fallopian tubes and uterus. Our lawyer in Maryland is available to help women who have experienced severe side effects after the implantation of the Essure birth control device.
What is Essure?
Essure is a procedure that sterilizes a woman by implanting a coiled, soft, metal device in the fallopian tubes. The outpatient, non-invasive surgery takes about ten minutes, after which time the implant attaches to the fallopian tube walls and grows to approximately 1.5 inches. This device has been used on more than 750,000 women around the world and is made of polyester fibers, titanium, nickel, platinum, stainless steel, and silver-tin. It’s a permanent, irreversible, non-surgical birth control device that doesn’t require any incisions in your body. The physician performs the procedure by going through the vagina, then the cervix and uterus to place the device in the correct spot.
This contraceptive option takes three months to take effect fully. Scar tissue grows around the implant, blocking off the fallopian tube and preventing conception. Doctors confirm the Essure device and tissue growth are working using an x-ray of the vagina or an ultrasound.
The side effects associated with the device breakage and migration include:
Painful sex or sexual issues
Injuries to the bowls or bladder
Uterus or fallopian tube perforation from device movement
The FDA Black Box Warning
The FDA decided to require the makers of Essure to warn patients about the potential damage the implant can cause when it breaks apart in February of 2016. They also made Bayer and Conceptus provide a Patient Decision Checklist to ensure women know what they’re signing up for when they choose Essure. The FDA reiterated this message in July 2018 and added that both the doctor and patient must sign off on the Patient Decision Checklist providing further proof of informed consent. Women deserve to know that the device has potentially severe complications that may require one or more surgeries to correct. Some women had to undergo hysterectomies to address the damage caused by the Essure implant.
The Worldwide Essure Recall
Thousands of women around the world reported serious side effects, which led to a defective product recall. That recall only took effect in countries outside of the United States, though. Bayer and Conceptus have announced the birth control device will be off the U.S. market by the end of 2018. However, this recall only benefits the women who don’t have the implant already.
If you or someone you know has been implanted with the Essure device and suffered severe side effects, please contact our Maryland office at (410) 995-1515, our Virginia office at (703) 734-8790, or our Washington, D.C. office at (202) 554-1449. Our attorneys at Portner & Shure, P.A. for a FREE consultation.