Across the country, women are concerned over the potential side effects of Essure and how it could potentially cause a need for revision hysterectomy. This is because the Essure coils are directly implanted into the fallopian tubes, making surgery necessary for removal.
In some cases of serious side effects of Essure, women have had no choice but to remove the device due to allergic reactions to nickel, a metal used in the device’s parts.
The side effects of Essure vary between patients. Some of the most severe cases have resulted in ectopic pregnancies. In these cases, not only did the device fail to prevent pregnancy–it also led to implantation of the embryo outside the uterus.
The Essure birth control system is currently the only non-surgical form of female sterilization in the United States, and is highly preferred compared to traditional hysterectomy. Compared to more invasive tubal ligation, Essure requires only a relatively quick placement of an implant in each fallopian tube.
Eventually scar tissue forms around the coils that permanently blocks the fallopian tubes, which prevents fertilization. This ultimately allows for convenient female sterilization without the hassle of recovery time and expensive hospital bills.
Ever since it was released onto the market, hundreds of thousands of women have opted for the Essure device. However, numerous women have reported serious side effects of Essure that were allegedly not mentioned on the product’s label.
According to a report by WAND, Abbi M. of Shelby County, Il. had developed a blood clot “the size of a softball” soon after having Essure implanted. This complication was discovered after she was rushed into the emergency room for treatment after passing out in her shower. Another woman from Beecher City reported that she had to go to the emergency room for infections and pelvic pain.
Overview of Side Effects of Essure
Ever since Essure was approved in the early 2000s, over 4,500 injury reports detailing side effects of Essure have been filed with the FDA. In addition, thousands of women have reported developing serious injuries from the Essure implant, with posts indicating such on Facebook pages like Essure Problems and Essure Problems Illinois.
On these pages, patients report developing Essure side effects ranging from mild discomfort to allergic reactions. However, even with the large number of injury reports, Bayer HealthCare maintains that this product is perfectly safe and effective for its intended treatment.
Bayer has removed the product from the market in every country except for the United States. The FDA recently required Bayer to include a black box warning on the product’s packaging to detail potential side effects of Essure, but has not yet called for market removal.
Many consumer advocates have stated this warning is not enough, and that the Essure device is unreasonably dangerous to patients. There have already been many product liability claims filed against Bayer, alleging the company did not do enough to warn consumers against the potential risk of side effects of Essure.
According to the financial statements released by Bayer HealthCare, there have been 3,700 Essure lawsuits filed since January 2017. The company also reported losing $413 million in litigation and impairment fees to patients who allegedly suffered side effects of Essure.
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.
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