The Essure device has led to crippling health consequences to women who have used it, largely blamed on its design and the materials used in its construction.
Essure lawsuits have alleged that manufacturer Bayer and its predecessor, Conceptus, designed a product that they knew to be defective. Opponents of the device also say that the approval for Essure by the U.S. Food and Drug Administration was based on inadequate clinical studies and have criticized the agency for not acting more assertively when safety issues were reported.
In 2018, Bayer acknowledged that it was facing over 16,000 Essure lawsuits from women who have claimed injuries from the device resulting from device migration and organ perforation. These women have reported chronic pain and bleeding, autoimmune reactions, excessive fatigue, painful intercourse and more.
Essure Device Materials and Construction
consist of an inner core, a tightly wound spring resembling a small, curving knitting needle, which is made from stainless steel. Around this is wrapped a nickel-titanium coil. The “inner coil” is coated with a form of industrial plastic, known as polyethylene terephthalate (PET).
At the tip of the coil is a platinum “marker band,” which is intended to assist the physician during the implantation device. The components are soldered together with an alloy of silver and tin, commonly used in the manufacture of electronics.
Any of these materials can cause toxicity; however, the primary culprits appear to be the nickel-titanium alloy and the PET plastic contained in the device.
According to scientific studies, anywhere from 8 to 18 percent of women suffer from nickel allergies. Symptoms of nickel allergies generally show up as hives or edema. Hives (urticaria) appears as itchy, small pinkish-red bumps resembling chicken pox.
Edema is similar to hives, but manifest below the skin surface. Another disorder associated with nickel toxicity is pruritis, a condition that causes dryness and itching and may be accompanied by blisters, redness and swelling. There is also evidence to indicate that nickel exposure may result in an elevated risk of lung and nasal cancer.
It is not clear whether the nickel contained in the Essure device actually triggers nickel allergies or simply aggravates a pre-existing condition. However, an informational pamphlet and consent form from Bayer acknowledges that “some women may develop allergic reactions to the device following implantation,” which may include rash and itching, “even if there is no prior history of sensitivity.”
Polyethylene terephthalate is a form of polyester which is used in the manufacture of plastic bottles and some articles of clothing. The purpose of PET in the Essure device is to create a small amount of inflammation, resulting in the formation of scar tissue that ultimately blocks the Fallopian tubes. When PET fibers begin to degrade, they release acetaldehyde, a substance that also occurs in cigarette smoke as well as motor vehicle exhaust and is produced by the metabolism of alcoholic beverages. Exposure can result in liver damage and may raise the risk of cancer.
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.
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