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The metal implant was designed to be a permanent, non-hormonal method of birth control for women.

Essure

Published on Jun 19, 2017

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PRESENTATION OUTLINE

Essure

A Controversial Sterilization
The metal implant was designed to be a permanent, non-hormonal method of birth control for women.
Photo by pablo/T

In 2002, a novel hysteroscopic sterilization device was made available after expedited review and premarketing approval by the FDA.

Hysteroscopic sterilization procedure - a type of tubal sterilization that does not require an incision.

Two metal and fiber micro-coil inserts are placed into each fallopian tube. After about three months, scar tissue develops around the inserts and blocks the fallopian tubes, preventing pregnancy.
Photo by DES Daughter

The metal part of the device consists of a stainless steel inner coil and an expanding nickel titanium outer coil with PET fibers.

Cause for concern. 4% of all patients tested to titanium will be allergic to it, those affected by titanium allergy, the symptoms can be multiple and bewildering. These can range from simple skin rashes to muscle pain and fatigue.

Thousands of women with the medias help have come forward with stories of injuries and malfunctions related to their experiences.

Photo by CaliforniaJD

9,000

FDA reports the device has caused serious side effects
Photo by Daniel Y. Go

Over 1,113 pregnancies in patients with Essure

Of the total pregnancies reported: 253 live births were reported. 138 were reported as ectopic pregnancies; 75 were reported as elective terminations of pregnancies, and 261 were reported as other pregnancy losses. In the FDA Maude database pregnancies were marked as "device operates differently than expected" or "Patient device incompatibility".

Reported Complications

  • Allergy or hypersensitivity to device
  • Chronic pelvic pain
  • Increased & Irregular bleeding
  • Weight gain
  • Unplanned Pregnancy
  • Hair loss
  • Fatigue

Severe Complications

  • Perforation of the Uterus or Fallopian tubes
  • Intra abdominal/pelvic device migration
  • Additional surgeries, including hysterectomy
  • Death

Fortunately, removal of the Essure device has been shown to resolve symptoms for many patients.

Essure Removal Procedures

  • Total Hysterectomy
  • Partial Hysterectomy
  • Oophorectomy
  • Bi-Lateral Oophorectomy
  • Salpingectomy
  • Bi-lateral Salpingectomy
  • Salpingo-Oophorectomy
Fortunately, removal of the Essure device has been shown to resolve symptoms for many patients.

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B Fonseca

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