Essure Side Effects May Be Linked to FDA Death Report

With health experts and consumer watchdogs increasingly raising concerns about the risk of health problems from Essure birth control implants, a recent report submitted to the FDA raises questions about whether the contraceptive may have been linked to the death of a woman who suffered a severe infection.

According to an adverse event report submitted to the FDA’s MAUDE (Manufacturer and User Facility Device Experience) Database, a woman went into renal failure and died in August 2013, after undergoing an Essure procedure. The cause of death was attributed to Necrotizing Group A Streptococcus infection, also known as streptococcal toxic shock syndrome or a flesh-eating disease.

The infection killed the tissue in the woman’s cervix, fallopian tubes and uterus after the Essure birth control was implanted in her right and left fallopian tubes.

In the report submitted by Bayer Healthcare on September 18, the manufacturer added narrative indicates that the attending physician does not directly link the death to the Essure insert or procedure. However, the report adds to recent media coverage surrounding the potential Essure side effects women may face from the birth control coils.

The Mayo Clinic and others list risk of infection as a leading complication following Essure procedures.

A similar case was reported in the Journal of Women’s Health in 2011, indicating that a 24-year old woman contracted a a Group A Streptococcus infection after an Essure implant three years earlier. She too reported worsening abdominal pain and eventually required a total abdominal hysterectomy.

Essure Complications

Essure birth control is a transcervical sterilization procedure, which is marketed as a less expensive, easier and safer alternative to tubal ligation surgery. Approved by the FDA in 2002, Essure was originally designed and manufactured by Conceptus, before being acquired by the pharmaceutical giant Bayer. More than 750,000 women have undergone Essure birth control surgery, according to prior data released by Conceptus.

The birth control implant is offered as an outpatient procedure by many medical facilities. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

The FDA has logged more than 850 reports of adverse side effects since 2004, which suggests that thousands of problems have been experienced, since it is widely acknowledged that only about 1% to 10% of all adverse events are ever reported to the FDA.

Among reports submitted to the federal regulatory agency are more than 150 Essure complications involving the device moving and puncturing fallopian tubes or the uterus, with nearly 100 women requiring hysterectomies to remove Essure birth control following severe complications. In addition, at least 150 reports have been filed involving doctors complaining of the device breaking during insertion and numerous other problems with allergic reactions and side effects.