Essure Lawsuits - Consumer Justice Foundation

Essure Lawsuits

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Women implanted with the Essure permanent sterilization device may be at risk for complications like device migration, perforation of the fallopian tubes, allergic reactions and death.

Bayer Healthcare’s Essure birth control system may not be as well-known as other more popular forms of birth control, like Yaz and Yasmin, but the risk of side effects from the medical device are equally as alarming. Essure is a permanent sterilization device consisting of small coils that are inserted into the fallopian tubes during a transcervical procedure, and the implant works by promoting the growth of scar tissue in and around the coils, thereby preventing pregnancy. However, an Ohio doctor recently attributed a woman’s death to the Essure birth control system, and other severe side effects like perforation of the fallopian tubes and migration of the device to other parts of the body have been linked to the sterilization device. If you believe you have been harmed by serious side effects of the Essure birth control system, contact a knowledgeable Essure injury lawyer today to explore your possible compensation options.

Essure Alternatives for Permanent Birth Control

With increasing concerns about the potential for Essure to cause severe side effects in users, many women are seeking safer alternatives to permanent sterilization, even if it involves undergoing surgery. There are a few possible alternatives to Essure for permanent birth control, including:

  • Tubal ligation (tubectomy)
  • Hysterectomy
  • Laparoscopic surgery

FDA, Essure and Side Effects

2015 – The FDA launches an investigation into the safety and effectiveness of Essure, after receiving a petition for an Essure recall that alleged fraudulent activity on the part of Conceptus, the original maker of the birth control implant.

May 2015 – A New York Times report indicates that the FDA has received more than 4,000 reports of side effects or complications involving Essure, including reports of severe pelvic and back pain, heavy or prolonged menstrual periods, and coils that punctured the fallopian tubes and caused damage to other organs.

June 2015 – The FDA adds a new page titled “Essure Benefits and Risks” to its website, highlighting the alleged long-term side effects of Essure, including pelvic pain, perforation of the uterus, device migration, unintended pregnancy, and rash and itching associated with a nickel allergy.

September 21, 2015 – The FDA posts a 90-page review of Essure online, warning that post-marketing data regarding the safety and effectiveness of Essure is limited.

September 24, 2015 – The FDA’s Obstetrics and Gynecology Devices Advisory Panel convenes to re-examine the safety and effectiveness of Bayer’s Essure birth control implant. More than 20 women testify at the hearing, calling for an Essure recall, and the panel rules that Essure may not be an appropriate form of birth control for certain women.

February 2016 – The FDA issues a press release announcing that Essure will be required to carry a “black box” warning highlighting the potential for the sterilization implant to migrate out of position and perforate the uterus or fallopian tubes.

Essure Side Effect Studies

April 2014 – The journal Contraception publishes research comparing the effectiveness of Essure versus traditional tubal ligation for pregnancy prevention. According to researchers, 96 out of 1,000 women who receive an Essure implant become pregnant within 10 years, which is nearly four times the risk of pregnancy with tubal ligation.

April 2015 – A medical report highlighting the long-term effects of Essure birth control is published online in The Journal of Minimally Invasive Gynecology, with researchers linking the permanent sterilization device to chronic pelvic pain, recurring pain with intercourse, and recurrent painful and unusually heavy periods after five years.

September 2015 – An editorial published in the New England Journal of Medicine points out that the FDA’s advisory panel meeting comes more than ten years after Essure first entered the market in the United States, raising doubts about the effectiveness of the FDA’s pre-marketing and post-marketing regulations.

Why We Think Bayer Should Be Held Liable for Essure Side Effects

Since it first approved Essure for consumer use in November 2002, the FDA has received more than 5,000 adverse event reports associated with the controversial birth control implant, including 3,353 cases of chronic abdominal pain, 1,408 cases of irregular periods, 1,383 cases of severe headaches, 966 cases of fatigue, 936 cases of weight fluctuation, and four deaths, one due to uterine perforation during placement and one due to an air embolism during surgery to remove the device. According to a citizens’ petition filed with the FDA, an inspector was given records of more than 16,000 adverse event reports made to Essure’s original manufacturer, Conceptus, from 2011 to 2013, when Bayer acquired the company, which means Bayer may have known about the risks of Essure from the very beginning. Lawsuits brought against Bayer over alleged Essure side effects in the future will likely include the following allegations:

  • That Conceptus manufactured a defective and unreasonably dangerous medical device
  • That Conceptus and Bayer marketed Essure as a safe and effective form of permanent birth control
  • That Bayer knew or should have known about the risk of side effects allegedly associated with Essure
  • That Bayer intentionally misled women in regards to the safety and effectiveness of Essure
  • That Bayer failed to provide consumers and the medical community with adequate warnings about the risks of Essure
  • That Bayer continued to sell Essure to women, despite these risks
  • That Bayer failed to conduct clinical trials examining the long-term effects of Essure for pregnancy prevention

What should you do? If you have suffered complications like device migration or perforation, you should contact a lawyer as soon as possible to discuss filing an Essure lawsuit.

According to Bayer, approximately 750,000 women have already received an Essure implant for permanent pregnancy prevention, and as more information comes to light about the risk of Essure birth control side effects, many more product liability lawsuits are expected to be filed against Bayer Healthcare in the coming months. If you received an Essure birth control implant in the past, and you have since suffered side effects like migration of the device, chronic pain, unintended pregnancy, or perforation of the fallopian tubes, you may be entitled to financial compensation for your injuries. Our consumer advocates at the Consumer Justice Foundation are dedicated to protecting the rights of consumers harmed by dangerous medical devices, and can help put you in touch with a knowledgeable attorney who has experience handling Essure injury claims.

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