Essure Faces Criticism after Hundreds of Reported Adverse Events
According to ABC News, Erin Brockovich, who led the 1993 case against Pacific Gas and Electric Co., is now focusing her attention on the popular birth control, Essure.
How Essure Works
- Approved by the U.S. Food and Drug Safety Administration (FDA) in 2002, Essure is an irreversible birth control system in which two small metal coils are place inside the fallopian tubes.
- The system relies on the body creating scar tissue around the metal inserts which, after about three months, should block sperm from reaching the egg.
- As Essure does not take effect immediately; women are encouraged to use other forms of birth control until an x-ray confirms the scar tissue building process is complete.
Complications Experienced while on Essure
“The pain was incredible. It was like fire inside your body… It felt like child delivery for days, and days, and days.” – Essure patient Shelly Towndrow to ABC
- Since its approval in 2002, over 700,000 women have undergone the Essure procedure.
Since 2004 the FDA has received 838 adverse event reports including:
- 150 reports of coils which have broke or misfired.
- 91 patients have undergone hysterectomies in order to remove the coils.
- 80 women have become pregnant after undergoing the Essure procedure.
- Hundreds more have reported the inserts moving or puncturing the fallopian tubes.
- According to Brockovich, thousands of women have experienced problems with the procedure beyond those events reported to the FDA.
- Brockovich further argues that the two years of clinical trials that Essure underwent before being granted approval were not enough to adequately determine the efficacy of the Essure system.
Other Side Effects and Heath Risks of Essure
Following information provided by MayoClinic:
- Perforation of the uterus or fallopian tubes
- Tubular blockage
- Increased risk of ectopic pregnancy
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