Essure

Complications After Essure?

If you suffered complications from the Essure contraceptive device, you may wish to explore your legal options. 1-800-LAW-FIRM will fight for the justice your family deserves.

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 complete, 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.

About Essure

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 United States Food and Drug Administration (FDA) recently announced that Bayer, the drug manufacturer of Essure, is now mandated to place a black box warning on the device’s label. The warning  will highlight significant health and life-threatening  conditions that could arise from the use of this  device. Essure was approved  by the FDA in 2002. Since that time, more than 5,000  patients filed complaints reporting a myriad of complications including unplanned pregnancies, stillbirths, miscarriages and chronic abdominal pain. Some cases were so severe, that the patients were forced to undergo hysterectomies.

Essure has since been removed from the market in other countries due to “commercial concerns.” Bayer claims that their decades of clinical studies prove the safety 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.

Understand 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.

In the News

The links below lead to Essure specific news stories as well as interviews with women who experienced adverse and life-altering injuries.

• CNN: “FDA mandates new warnings, new data for Essure contraceptive device”
• CBS News: “Bayer Halts sales of Essure sterilization implant outside of U.S.”
• BBC News: “Sterilization implant withdrawn from non-U.S. sale”
• Washington Post: “FDA to require “black box” warning, but leaves controversial Essure implant on market”

Understand 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.