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FDA steps in to ensure that patients understand the risks of Essure Permanent Birth Control after documented side effect complaints

In 2002, the U.S. Food and Drug Administration (FDA) approved the Conceptus Inc., a subsidiary of Bayer since 2013, manufactured Essure Permanent Birth Control System. The contraceptive is marketed as the “only permanent birth control you can get with a non-surgical procedure.” Furthermore, a focal marketing attribute of Essure is that the procedure is quick, most times only lasting approximately 10 minutes and can be executed without the need for any anesthesia. Also, the procedure is done with no need for incisions during the entirety of the process. The procedure consists of implanting a small flexible coil, that reaches 1.5 inches once implanted and expanded. The doctor implants the coil through the cervix and vagina ultimately positioning it at the entrance of each fallopian tube.

According to a clinical study, produced by the makers of the birth control system, Essure was allegedly shown to maintain an almost perfect percentage of effectiveness in preventing pregnancies. Although, many of the women that have used Essure would strongly disagree as well as complain about the various side effects they have suffered from having the procedure.

Since the product’s existence there have been around 10,000 documented complaints due to ineffectiveness and various side effects, even multiple deaths, related to Essure. The side effects, include but are not limited to, are:

  • Abnormal bleeding
  • Allergic reactions
  • Ectopic pregnancy
  • Levels of persistent pain
  • Tearing of the uterus (if coil moves)
  • Tearing of fallopian tubes (if coil moves)
  • Severe Cramping
  • Dizziness or lightheadedness
  • Headaches
  • Device expulsion, breakage or migration
  • Device incompatibility due to allergies
  • Weight fluctuations
  • Hypersensitivity reactions

Recently, the FDA requested that Essure place a special warning “black box” warning on the product. Also, Bayer must conduct a new post-market observational study in a “real-world environment” to observe Essure usage in current patients. Lastly, the FDA is mandating that doctors carry a “patient decision checklist” that will highlight the benefits and risks of Essure prior to them making their final decision of whether or not to undergo the procedure.