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ESSURE: When a Permanent Solution Becomes a Permanent Problem

Today’s woman is often faced with an overwhelming number of options when it comes to birth control. When a woman knows that her family is whole, a decision has to be made. And this decision, like other life-altering choices, cannot be taken lightly. Each woman must choose the option that is best for not only herself, but also for her family.

1-800-LAW-FIRM understands this decision, and knows how heartbreaking it must be when a well-thought out solution becomes a daily fight against potentially life-threatening symptoms.

Information about Essure:

IMPLANTED DEVICE

Essure consists of two nickel-titanium based alloy coils that are embedded in the fallopian tubes to permanently prevent pregnancy. Bayer, the makers of this device, state that the inserts form a “natural” barrier and are constructed to remain “securely in place.”

WHAT IT LOOKS LIKE ON PAPER

Essure is touted as the only permanent contraceptive option for women that doesn’t require a surgical procedure. The approximate 10 minute process to implant the coils into a woman’s fallopian tubes, can be completed in a Doctor’s office.

Women are informed that other benefits of using Essure include:

  • No incisions are made during the in-office, 10 minute implantation process
  • The inserts are free of hormones
  • Pregnancy prevention is permanent
WHAT IT LOOKS LIKE IN REALITY

Bayer has received thousands of reports from women and physicians about the severe and sometimes permanent side-affects and symptoms this device is causing in women who adopted the Essure device as their method of permanent birth control. Some of the more serious consequences of device use include:

  • Ectopic pregnancy
  • Miscarriage
  • Perforation of the uterus and other organs
  • Chronic, intense cramping and abdominal pain
  • Heavy feminine bleeding
  • Severe menstrual cramps
  • Device migration info the pelvic region
  • Required surgery to remove inserts
  • Required hysterectomy
  • Autoimmune disease development

Other symptoms include:

  • Hair Loss
  • Chronic Pain
  • Skin rashes/allergies
  • Fatigue
  • Headaches
  • Mood changes
  • Vaginal infection
FDA BLACK BOX WARNING

The Federal Drug Administration (FDA) recommends that Bayer utilize a black box warning label that is designed to highlight significant health or life-threatening possibilities that could arise with the use of this product. Essure was approved for public use by the FDA in 2002. Since that time, more than 5,000 Essure patients filed complaints with the FDA criticizing the device and complaining of a myriad of symptoms including unplanned pregnancies, stillbirths, miscarriages and chronic abdominal pain. It is important to understand, that even though the warning label is recommended by the FDA, it is not mandatory.

FDA Example of an Essure Black Box Warning

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.

FDA MANDATED PATIENT DECISION CHECKLIST

The FDA recommends that any woman opting to undergo the implantation of the Essure device for sterilization purposes, should review and sign a checklist along with her physician. This FDA checklist example, outlines all the possible dangers and benefits of using the Essure device. It gives the woman considering the device all of the information she needs in order to make an informed decision before moving forward with the device implantation.

KNOW YOUR HEALTHCARE OPTIONS

Women are encouraged to speak with their physician regarding all of the birth control options that are available to her. A physician can make recommendations based on their patient’s medical history and tolerance level for dyes, metals and other factors.

KNOW YOUR LEGAL OPTIONS

The legal team of 1-800-LAW-FIRM has years of experience helping women with dangerous medical devices. Consultations are free and confidential.

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