The Essure Permanent Birth Control System is a form of permanent birth control that over 750,000 women have been prescribed to prevent pregnancy. Essure was originally produced by Conceptus Inc. and was approved by the U.S. Food and Drug Administration in 2002. In 2013, Bayer purchased Conceptus Inc. and began marketing Essure as the only “FDA-approved permanent form of birth control with a procedure that can be performed in an office setting without general anesthesia.”
A non-hormonal form of birth control, Essure was designed to be used as an alternative to female sterilization techniques such as tubal ligation. It consists of two coils made of stainless steel, nickel titanium, and polyethylene fibers. It is marketed as a quick procedure that can be performed in about ten minutes in a doctor’s office. To implant, doctors use a small metal catheter to guide the device into the vagina and carefully insert one at the entrance of each fallopian tube.
Complications of Essure
Some women who have had the Essure device implanted have experienced complications, ranging from autoimmune problems and migraines to hair loss. In other cases, Essure can become dislodged, perforating the walls of the fallopian tubes and other organs.
Studies and reports of adverse health events caused by Essure include:
- Severe abdominal cramping and pain
- Arm and leg pain
- Abnormal bleeding
- Vaginal infection/discharge
- Painful intercourse
- Back pain
- Heavier periods
- Weight fluctuation
- Unintended pregnancy
- Hypervolemia (fluid in blood)
- Malposition of device
- Device migration
- Device breakage
Though Essure was originally intended to be nonreversible, procedures have recently been developed that allow for the removal of the device. The reversal process is more complicated than insertion, requiring doctors to make small incisions above the pubic hairline to access the fallopian tubes. They then make small cuts in the fallopian tubes to cut out the Essure coils and remove any scar tissue.
Unfortunately, in some cases where complications arise, removal may not be an option. Essure can cause so much damage to the fallopian tubes and uterus that it may require the patient to have a complete hysterectomy surgery. Not only are women who have hysterectomies no longer able to have children, they may also experience long-term symptoms that affect their quality of life, such as bowel dysfunction, incontinence, sexual problems, or pelvic organ prolapse.
In addition to the over 5,000 complaints women have made to the FDA and a “dramatic increase” in reported events over the last two years, there have been several deaths linked to Essure. According to FDA data, there have been 15 instances of pregnancy loss as a result of Essure. There have also been reports of two infants dying after live birth. Additionally, four women who were prescribed Essure have died.
Despite the numerous reports of complications and, in severe cases, death, the FDA has not officially recalled Essure. In a meeting, held on September 24th, 2015, the FDA stated that more studies on Essure are necessary but said that conducting these trials may not be “practical or feasible.”
Instead of banning this dangerous product, the FDA issues a list of recommendations, stating that:
- Patients should be chosen carefully
- Women with an allergy or sensitivity to nickel should not use Essure
- Doctors should advise patients of risks
- Women who have autoimmune disorders, chronic pelvic pain, or have had uterine surgery in the past should not use Essure
- Physicians should receive more training on Essure use
Compensation for Essure Injuries
If you or a loved one has had Essure implanted and are experiencing complications, you should contact your doctor as soon as possible to identify the cause of the symptoms and discuss device removal.
Despite the multiple reports of injury, Bayer Healthcare continues to market Essure to consumers and sell the product to doctors. If you have been injured as a result of Essure, you may be entitled to financial compensation for your pain and suffering.
The attorneys at the Law Offices of Michael A. DeMayo have helped many victims of dangerous drugs and medical devices fight for their rights and the compensation they deserve. Call us today at 646-493-8508 to schedule a free and confidential consultation.