Injury and Defect Reports Relating to Essure
Lieff Cabraser is investigating reports from women across the U.S. relating to injuries alleged to have been caused by their use of the Essure birth control device. These reports include device migration (movement after implantation within a women’s body, including movement into the lower abdomen and pelvis), device breakage, and tissue perforation caused by the device, as well as premature hysterectomy and allergic and autoimmune reactions leading to further injuries. There are also reports of pregnancies occurring despite the device’s claimed 99%+ effectiveness rate, and that such pregnancies have led to fetal deaths.
Regulatory Violations Cited and Occurring
Additional concerns focus on reports of regulatory violations relating to Essure production, including objectionable conditions at manufacturing plants, violations of good manufacturing processes, and issues relating to the handling of adverse event reports (that is, the company’s handling of reports relating to complaints of injury by Essure users). The manufacturing defects cited include wrongly used non-conforming materials, failure to use pre-sterile and post-sterile cages, post-market (after-sale) surveillance failures, and advertising inaccuracies.
After the FDA conducted formal hearings in September of 2015, a black box (elevated) warning was added to Essure in response to concerns about product dangers and multiple related threats to women’s health over use of the Essure product.
Are Essure’s Warnings Sufficient?
Beyond the injuries themselves, women are very concerned about what they claim are insufficient warnings and alerts on Essure:
- No warning of device migration (movement within a woman’s body). As of 2014, reports began to surface of Essure devices migrating inside of women’s bodies, moving into the lower abdomen and pelvis. Research is ongoing into how prevalent the migrations and attendant problems are in women across the U.S., but there are numerous reports of colon, stomach, and other organ perforations.
- No warning to physicians of device breakage. Some packaging included small warnings to patients of the possibility of the Essure devices breaking, but no information or indication was provided of when the device might break (upon initial insertion or later); increased risks of injury relating to breakage and/or concurrent device migration (movement); or increased risk of reoperation with breakage.
- Perforation risks: There were labeled warnings relating to Essure device perforations (i.e., the device pushing through or out of a woman’s body, but while the possiblity was mentioned the language downplayed any risks, stressing the rarity of such occurrences and noting only that such punch-outs might occur.
- Available patient information also is seen by some as greatly downplaying the reoperation risks.
- Pregnancy Dangers and Risks: Bayer has acknowledged hundreds of fetal deaths in pregnancies that occurred despite Essure implantation, including ectopic pregnancies, despite manufacturer claims of 99+% pregnancy prevention effectiveness.
- Allergic reactions: The Essure device contains notable amounts of the metal nickel, and measurable amounts of the metal are actually released into women’s bodies by the devices. Women are reporting injuries relating to nickel allergies, including rash, pruritus, and hives. Medical literature indicates that more than 1/3 of women in the U.S. have such nickel allergies.
- Autoimmune reactions: Women using the Essure device are also reporting autoimmune reponse injuries, including hair loss, tooth loss, weight gain, and migraines, none of which were included in product warnings. And though there were warnings relating to excessive bleeding and significant and chronic pain, victims claim those warnings were minimized and inadequate.
Contact National Women’s Injury Attorneys at Lieff Cabraser
Lieff Cabraser represents hundreds of women nationwide in cases involving injuries from medical devices and products like transvaginal surgical mesh and power morcellators alleged to have spread cancer through their bodies. Our attorneys approach these cases with expertise and great sensitivity, and all information you provide is held in the strictest confidence. Please use the form below or call us toll-free at 1 800 541-7358 and ask to speak to attorney Sarah London. There is no charge for our review of your potential case.