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A Pennsylvania woman has filed an Essure lawsuit against the birth control implant manufacturers after the product allegedly migrated into her uterus forcing her to have a hysterectomy.
Plaintiff Melda S. is suing Bayer Healthcare Pharmaceuticals Inc. for fraudulent concealment of adverse reports that documented migrations and perforations from Essure consumers and the FDA. Melda alleges that Bayer’s disregard for the safety of Essure users was “malicious, intentional, and outrageous.”
Melda was implanted with Essure for its intended contraceptive purposes in May 2013. After the implant, she alleges she began experiencing painful Essure side effects, including: skin blisters, severe abdominal pain, hair loss, weight gain, and severe bleeding.
After being hospitalized on numerous occasions, Melda was required to undergo surgery to remove one of the Essure coils out of her uterus, resulting in a hysterectomy. Melda claims there was no reason for her to believe that Essure, marketed as “the most effective permanent birth control available – even more effective than tying your tubes or a vasectomy,” would have such serious and permanent side effects.
The Essure lawsuit alleges Bayer in is breach of advertising, marketing, and website warranties based on the following claims:
- Zero pregnancies in clinical trials – plaintiff alleges there were four pregnancies during trials.
- Surgery free – plaintiff claims all Essure procedures are performed under hysteroscopy, which is a surgical procedure.
- Worry free: “once your doctor confirms that your tubes are blocked, you never have to worry about unplanned pregnancy” – plaintiff reports that Essure consumers have a 10 times greater risk of pregnancy after one year those who use laparoscopic sterilization.
Plaintiff Melda is also suing Bayer for negligence, strict liability, and unfair trade practices.
Essure Birth Control Overview
Essure was considered a medical breakthrough when it became available on the market 13 years ago. It was marketed as a permanent birth control for women who wanted to be sterile but didn’t want to undergo surgery. The contraceptive implant Essure was advertised to last a lifetime and provided an alternative to tubal ligation surgery that could be implanted in a doctor’s office in just 10 minutes. With no surgery or recovery time, hundreds of thousands of consumers began relying on Essure as a permanent birth control option.
Essure is reported by manufacturers to work by inserting two coils made of metal and polyester through the vagina and uterus and placing them inside each fallopian tube. Essure manufacturers claim that after implanting Essure, scar tissue begins to develop around the metal coils, which in turn blocks the fallopian tubes and prevents conception. The development of scar tissue can take about three months, so women are encouraged to follow up with a physician to make sure the procedure worked correctly before solely relying on it as birth control.
Long-Term Essure Study
When the FDA fast-tracked the approval process for Essure, the agency was concerned that claims of “lasting a lifetime” would need follow-up testing to confirm. In fact, approval of the Essure birth control implant only came with the understanding that a five-year study would take place. The release of that study came out in recent months, which was eight-years after it ended.
The Essure study concluded that:
- Only 70 percent of original study participants were followed for five years
- 1 in 15 reported continuous painful periods
- 1 in 20 reported ongoing pelvic pain
- 1 in 25 reported painful intercourse
- 38 percent reported recurring heavy periods
- 15 women had hysterectomies
Essure Lawsuits
Numerous Essure lawsuits have been filed by women who claim the product was responsible for severe health risks including migration and perforations. Since its approval, more than 4,500 serious adverse event reports have been filed with the FDA, claiming Essure caused excessive menstrual bleeding, ectopic pregnancies, miscarriages, organ perforation, and severe back pain.
Contact a lawyer if you experienced any serious side effects of the birth control implant Essure.
The Essure Birth Control Lawsuit is Case No. Case 2:14-cv-07317-LFR, in the U.S. District Court for the Eastern District of Pennsylvania.
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.
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