Essure® Birth Control for Women
Essure® is a women’s birth control device developed by Conceptus Inc and approved by the FDA in 2002. (Conceptus was purchased by Bayer AG of Germany in June, 2013.) The product will be taken off the market in the United States by the end of 2018.
Essure® is a metal coil that is inserted into each fallopian tube to prevent fertilization and was designed to be an alternate to tubal ligation. The procedure for installing Essure® is usually performed in the doctor’s office, making it less costly than the tubal ligation which must be performed under anesthesia in the hospital.
What you need to know about Essure®
During the years since Essure® was introduced to the market, it has been reported to cause both short term and long term medical issues in some women. In 2016, Bayer was made to place a “Black box” warning (the FDA’s most severe warning) for anyone getting the Essure® implant. The warning stated: “Some patients implanted with the Essure® System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. “
According to a 2018 article in the Washington Post, “Pharmaceutical giant Bayer said that it will halt sales of its controversial Essure® birth-control device in the United States at the end of the year, bringing to a close a protracted battle over an implant that thousands of women blame for serious health problems, including persistent pain and perforations of the uterus and fallopian tubes.”
Long term risks
As stated on the manufacturer’s website, Essure® can possibly cause:
- Pain (acute or persistent) of varying intensity and length of time may occur and continue following Essure placement.
- There are reports of an Essure® insert being located in the lower abdomen and pelvis
- Patients with known hypersensitivity to any of the components of the Essure® system may experience an allergic reaction to the insert. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Symptoms reported in women using Essure® that may be associated with an allergic reaction include hives, rash, swelling and itching.
- If insert removal is indicated, surgery will be necessary.
The FDA has also included these warnings on its website regarding Essure®.
Have you had issues with Essure®?
Give us a call if you have had any of the following issues. We are available for a free and private consultation regarding possible legal action on your behalf.
- Uterine perforation
- Hysterectomy
- Device Migration
- Organ Perforation (the IUD tears through the cervix or the wall of the uterus)
- Allergic reaction to nickel or other metals
- Back pain
- Device expulsion
- Dizziness
- Fainting
- Headaches
- Pelvic cramping
- Pelvic pain
- Vaginal bleeding
Contact Longo Legal, PLLC
The focus of Longo Legal, PLLC is to assist patients who have been injured by defective medical devices or harmed by taking prescription drugs. If you or a loved one has had an Essure® birth control device installed, and has suffered, contact us by calling 855-566-4648 or email us at victor@longolegal.com so we can possibly help you.
Longo Legal, PLLC, is here to help you!
