Essure Birth Control Implant

Defective Medical Device Lawyer For New York And New Jersey

If you or a loved one was injured by the Essure birth control device implant, the medical device attorney at the Law Offices of David J. Hernandez & Associates is here to help.

Essure was approved by the FDA in 2002 and marketed as a permanent and safe birth control implant device and alternative to tubal ligation. Since that time, the FDA has received over 32,000 complaints about Essure, including severe and chronic pain, device dislocation, genital hemorrhage, perforated organs as well as 80 reported deaths in the United States. In December 2018, manufacturer Bayer stopped selling and distributing Essure.

What Is Essure?

Essure is a permanent birth control device that is implanted into the fallopian tubes. The Essure device is a flexible coil that is made of nickel titanium alloy and polyethylene (PET) fibers.  A doctor inserts a coil into each fallopian tube, where it expands. The PET fibers cause scar tissue to develop, which over time blocks the tubes and prevents fertilization.

Essure was introduced in 2002 by Conceptus, and at the time it was considered a breakthrough because it was an alternative to surgical sterilization (tubal ligation). In 2013 Bayer acquired Conceptus.

In 2015 and 2016, the FDA received over 10,000 medical device complaints for Essure. Also in 2016, 30 deaths were also reported with the use of Essure, including 4 adult women, 18 pregnancy losses, 2 infants and a stillborn.

Essure problems include:

• Severe and chronic pain in the lower abdomen
• Perforation of the fallopian tubes, uterus, or organs in the lower abdomen and pelvis
• Severe nickel allergies
• Device migration
• Need for device removal (with or without hysterectomy)
• Unintended pregnancy, including increased risk of ectopic (outside of the uterus) pregnancy
• Severe menstrual cramps and/or persistent, abnormal increased menstrual flow
• Autoimmune disease
• Death

The most common problems with Essure include extreme pelvic and abdominal pain, heavier menstrual bleeding, migraines, fatigue, weight changes, pregnancy, pregnancy losses, patient-device incompatibility (nickel allergy), breakage and movement of the device throughout the body, as well as the coils cutting into the uterus and other organs.

Hundreds Of Fetal Deaths Caused By Essure

On Feb. 16, 2016, Congressman Mike Fitzpatrick of Pennsylvania wrote a letter to the FDA citing an independent report which revealed 303 fetal deaths had been caused by Essure.

Fitzpatrick authored the E-Free Act {H.R. 3920}, which called for the ban of Essure. He also brought attention to a complaint filed on behalf of several states alleging that Bayer paid illegal kickbacks to doctors for prescribing Essure.

Essure Black Box Warning

The U.S. Food and Drug Administration issued this “black box warning” label for Essure in November 2016:

• 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 the discussion of the benefits and risks of the device.”

This type of warning is the strongest warning label the FDA can require on a medical device and “is designed to call attention to serious or life-threatening risks.” The FDA also required a new clinical study to assess the risks of the device.

Medical Device Attorney Serving Brooklyn, The Bronx, Manhattan, Queens, Staten Island, New York And New Jersey

If you or a loved one has been injured by the Essure birth control medical device, you need a knowledgeable, experienced, compassionate and strong attorney who will fight for you to receive the compensation that you deserve for your injuries. The medical device attorney at the Law Offices of David J. Hernandez & Associates is that attorney. We handle all Essure and other defective medical device injury cases on a contingency basis, which means that you pay no attorney fees unless we recover compensation for you. Please call us for a free consultation at 347-318-4935 or contact us online today.