DEFECTIVE MEDICAL DEVICES & PHARMACEUTICAL INJURIES

Essure Lawsuit

Since Essure’s FDA approval in 2002, approximately 750,000 women have undergone the procedure worldwide according to a review by JMIG. Since 2002, thousands of women have suffered severe side effects due to the birth control device. As a result, many of these women filed an Essure lawsuit to receive justice for their pain and suffering. If you or someone you know has suffered physical and mental trauma due to the Essure device, Houston personal injury lawyers at Reich & Binstock want to help. Call us today at 713-622-7271 for a free consultation.

What is Essure?

The Essure device is the only nonsurgical, permanent birth control option approved for women between the ages of 21 to 45. It’s a small, flexible coil made from a combination of nickel, titanium, and polyethylene. A doctor inserts coils into each of the patient’s fallopian tubes through the vagina. In the weeks following the procedure, the coils irritate the lining of the fallopian tubes. This causes a buildup of scar tissue that blocks sperm from traveling up the tube to fertilize the egg. The device also prevents eggs from traveling down the tubes to the uterus.

How is Essure Inserted?

Like tubal ligation, Essure is generally considered permanent. Unlike tubal ligation, however, Essure is a non-surgical procedure. For many patients, Essure insertion takes only 10 to 15 minutes, and the entire visit can be completed within an hour. Because Essure is non-hormonal, doctors have recommended the device to patients who react badly to hormonal birth control, such as the pill.

How Effective is Essure?

Conceptus Inc.’s initial five-year clinical study of Essure estimated that it was 99.83 percent effective in preventing pregnancy. This efficacy rate rivals tubal ligation and is higher than many other forms of birth control. However, according to a 2015 analysis published in the New England Journal of Medicine, there has been a lack of studies about Essure. Additionally, there are methodological concerns about the published studies. For example, there has been an insufficient number of longitudinal studies. And this limited research may have resulted in minimizing concerns about Essure’s possible side effects.

Essure History

The Essure Permanent Birth Control system received FDA approval in 2002. In the same year, many doctors advertised Essure as a breakthrough for many patients: a form of permanent, nonsurgical birth control. Since its release, however, Essure has been the subject of numerous medical complaints, lawsuits, and increasing scrutiny by the FDA.

What are Common Essure Injuries and Side Effects?

Essure side effects range from mild to severe during and after the procedure. Some side effects resolve on their own, and some require immediate medical attention.

Essure Side Effects During the Procedure

Complications during Essure insertion include:
  • Device breaking during insertion, therefore requiring the doctor to remove the broken pieces
  • Perforation of the fallopian tubes or uterus. This can cause bleeding and damage to the bladder or the bowel
  • Allergic reactions to local anesthesia
  • Temporary mild to moderate pain

Essure Side Effects After the Procedure

Because the Essure insertion is an outpatient procedure, most women leave their doctor’s office within an hour. The most common side effects that women deal with once they go home include:
  • Pain and cramping in the pelvis or back areas
  • Vaginal bleeding
  • Headache and dizziness
  • Fainting
  • Nausea and vomiting
  • Device expulsion

Essure Confirmation Test Side Effects

Essure takes approximately three months to work following insertion. To double check that women can’t get pregnant, they must undergo the Essure Confirmation Test which uses a transvaginal ultrasound or a vaginal X-ray. Side effects of this test include:
  • Cramping
  • Dizziness
  • Fainting
  • Infection
  • Nausea and vomiting
  • Vaginal bleeding or spotting 

Essure Long-Term Side Effects

Lastly, Essure can cause side effects for months or even years after insertion. Some of the most common long-term injuries due to Essure include:
  • Chronic pain
  • Pain during sex
  • Serious infection
  • Heavy periods or hemorrhaging
  • Irregular periods
  • Device migration into the abdomen or pelvis
  • Poor positioning of the device
  • Device breakage
  • Metal allergy symptoms including itching, swelling, rash, hives
  • Fallopian tubes removal
  • Hysterectomy
  • Surgery to remove Essure
  • Unintended pregnancy
  • Ectopic pregnancy, which is an extremely life-threatening pregnancy that happens when the zygote implants into the wall of the fallopian tube
  • Miscarriage
  • Stillborn babies
  • Autoimmune disorders including lupus, rheumatoid arthritis, and chronic fatigue syndrome
  • Fatigue
  • Weight fluctuations
  • Hair loss
  • Depression and anxiety

Injuries and Deaths due to Essure

The FDA received 63,942 Essure side effects between 2002 and 2020. The most common side effect reported was chronic abdominal or pelvic pain, accounting for 37,413 reports. In second place was heavy and irregular periods, accounting for 17,332 reports. Lastly, the FDA received 94 reports of wrongful death that are directly related to the Essure device.

How Many Pregnancies Occurred with the Essure Device?

The FDA also received 4,328 reports of pregnancy in patients with the Essure device between 2002 and 2020. Approximately half of these pregnancies, 2,169, were lost. Of these lost pregnancies, 566 were reported as failed ectopic pregnancies.

What are the Chances of Becoming Pregnant after Essure Removal?

Some women who underwent the Essure insertion procedure later decided they wanted to have children. However, the damage of the female reproductive system due to Essure significantly lowers chances of future pregnancy. The chance of pregnancy after Essure removal sits around 32% according to Tubal Reversal. However, this number can be a bit higher for women under the age of 40.

Essure Black Box Warning

Because of the physical and mental trauma suffered due to Essure, the FDA ultimately required a black box warning for the birth control device in 2016. Since then, Essure sales have decreased by 70%. A black box warning is the highest safety-related warning required by the FDA. Presently, there are approximately 600 drugs and devices that have black box warnings. Surprisingly, 40% of people are taking at least one drug that has a black box warning, according to the director of pharmacy at the University Behavioral Health of Denton.
 
Additionally, the FDA restricted Essure sales in 2018. However, the device was never recalled. So now, only American healthcare facilities and doctors who utilize an FDA-approved checklist can buy and use Essure.

Essure Safety Studies

The FDA also started a post-market safety investigation in 2016 which requires Bayer to conduct more Essure side effect and effectiveness studies. The study will include approximately 2,800 women and will gather data about pregnancy, abdominal pain, uterine bleeding, allergic reactions, and autoimmune disorders. Additionally, the study will compare Essure to tubal ligation. Bayer will conclude the study in 2023.

The FDA reviewed a citizen petition alleging that Bayer had mislabeled Essure and that data about Essure safety had been changed during clinical trials.

Common Complaints in an Essure Lawsuit

Injuries caused by the Essure device have led to numerous lawsuits against Conceptus, Inc. and Bayer. The most common claims in these lawsuits include:
  • Negligent creation of the Essure device
  • The device migrating from the fallopian tubes to other organs instead of working as intended
  • Failing to warn women of the risks associated with the device
  • Lack of proper training for doctors before implanting Essure devices
  • Bayer making false statements about Essure’s effectiveness and safety
Expanding on the last point, Bayer marketed Essure as a nonsurgical form of birth control. However, thousands of women ended up receiving emergency surgeries anyway due to device breakage, organ perforation, and device removalTherefore, thousands of women had a solid case in their Essure lawsuit.

Bayer’s Defense Tactic

During an Essure lawsuit, Bayer often used a defense tactic called preemption. For example, the FDA, as a preeminent entity, approved Essure at the federal level. As a result, this approval protects Bayer from lawsuits that claim the company failed to warn women about Essure risks. The preemption tactic often complicated an Essure lawsuit. Some judges even dismissed cases for preemption.

Bayer Settlement for Essure Lawsuit

As a result of the thousands of Essure lawsuits, Bayer announced in August 2020 that it would pay a $1.6 billion settlementIt’s estimated that the settlement resolved approximately 90% of the 39,000 claims from women who suffered serious side effects due to Essure.

Contact a Personal Injury Attorney Today

If you or someone you know suffered severe injuries from Essure, you may be eligible for compensationIn an Essure lawsuit, you could receive damages medical care, therapy, pain and suffering, and lost work timeExperienced personal injury attorneys at Reich & Binstock can provide a free consultation to help you understand your options. Call us today at 713-622-7271.
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