Essure Birth Control
Mississippi attorneys helping women injured by Essure
The manufacturer and seller of Essure hid evidence from the Food and Drug Administration (FDA) of various risks associated with the birth control device in order to get government Premarket Approval, and has since failed to properly warn patients and physicians of the true risks. The lawsuits provide that if the manufacturer and seller had warned of the risks, patients would have chosen a different form of birth control, such as a hysterectomy, salpingectomy, tubal ligation, tubal fulguration, or application of clips.
What is the Essure Medical Device and Why is it Utilized
It is a permanent, non-surgical birth control device for women developed by Conceptus Inc., a company owned by Bayer. Essure was approved for use in the United States on November 4, 2002. The insertion of Essure does not require an incision (cut) or general anesthesia, and is also non-hormonal. During the procedure, which generally takes ten minutes and can be performed in a physician’s office, flexible coils are inserted through the vagina and cervix and into the fallopian tubes. Once in place, tissue grows in and around the device over a period of three months and forms a blockage in the fallopian tubes. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.
Three months after the device is placed in the body, a radiologist performs testing to make sure that the fallopian tubes are completely blocked and that the patient can rely on the device to prevent pregnancy. A contrast agent (dye) is injected through the cervix, and an x-ray is taken of the Essure coils to make sure no dye leaks past the medical device. Essure is considered a permanent form of birth control and is not intended to be removed.
What are the Side Effects, Problems and Risks of the Essure Medical Device
According to the Food and Drug Administration, the short-term risks from Essure include mild to moderate pain, cramping, vaginal bleeding, and pelvic or back discomfort.
The long-term risks include:
- Unintended pregnancy, including ectopic pregnancy
- Pelvic pain
- Migration (movement) of Essure inserts through the fallopian tubes into the lower abdomen and pelvis
- Perforation (puncturing) of the uterus or fallopian tubes
- Rash and itching associated with possible nickel allergy
The FDA received 5,093 reports of problems related to the device for the period November 4, 2002, through May 31, 2015. The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants. The most frequent problems have been pain (3,353), heavier menses/menstrual irregularities (1,408), headache (1,383), fatigue (966), weight fluctuations (936), movement of the device (482), device operating differently than expected (301), and device breakage (259).
If the implant separates, breaks and/or moves, attempted removal often requires multiple surgeries, sometimes requiring removal of the uterus entirely.
If you have been injured through no fault of your own, please contact the Diaz Law Firm. You can reach us online or by calling our toll-free number at 800-459-2222. Our team is available to speak with you about your potential case. We work on a contingency fee basis, which means you pay us nothing unless we recover for you. The Diaz Law Firm is a national firm that represents clients across the United States.