Essure

Many women who are looking for birth control that is permanent, but nonsurgical, have had the Essure Permanent Birth Control System, manufactured by the Bayer Corporation, implanted. The FDA approved Essure in 2002. Essure is made up of flexible coils put through the vagina and cervix and installed in the fallopian tubes for the purpose of sterilization. The irritation produced by the device pressing against the tissue of the fallopian tubes creates scar fibers that thicken the area and prevent sperm from traveling to a woman’s egg. However, there have been many complaints about harm arising in connection with Essure implantation. If you suffered injuries from Essure, you should consult a Boston Essure lawyer at the Naumes Law Group. We can investigate whether you should bring a product liability claim seeking compensation for your harm.

Injuries caused by Essure have included chronic pelvic pain, organ perforation, and abnormal bleeding. There have been reports of unintended ectopic pregnancies and even death. Some women have needed to have hysterectomies to remove the device and fix organs that have been damaged. Other consumers have reported migraines and allergic responses, as well as autoimmune responses, such as weight gain, rash, hair loss, and fatigue. Many women were not provided with enough information about these potential risks before the implantation of the device.

In 2018, the FDA issued an order to restrict the sale and distribution of the device. The FDA has imposed requirements on Bayer, such as conducting a post-market study and adding a boxed warning and checklist to the labeling. The manufacturer was ordered to implement the restrictions right away and to submit to continued review and monitoring by the FDA. However, after facing many thousands of lawsuits by injured consumers, Bayer announced that it will no longer sell or distribute Essure in the United States as of December 31, 2018.

If you suffered injuries due to Essure, you may be able to recover damages by bringing a product liability lawsuit against the manufacturer with the assistance of the Essure attorneys at our Boston firm. Manufacturers may be held strictly liable for defective medical devices. Strict liability requires you to show that a product had an actionable defect, the defect caused your injuries, and you sustained actual damages. Unlike negligence, strict liability does not require you to prove that the manufacturer's conduct breached a particular duty of care.

Medical devices can be defective in one of three actionable ways: design, manufacturing, or marketing. Design defects exist when the product's design is flawed, such that it is intrinsically dangerous to consumers when it is made as designed. When there is a design defect, it exists in every specimen of the product. Manufacturing defects, on the other hand, tend to be one-offs that arise as a result of a flaw in the manufacturing process. Manufacturers can also be held liable for marketing defects, which are flaws in the warnings and other information given to consumers about the product. Manufacturers are required to provide warnings about dangers that are known to arise from the product, such as potential injuries that could arise in connection with using a medical device. If the learned intermediary doctrine applies, however, these warnings may be provided by the manufacturer to a doctor, who is expected to pass along the warnings to the patient.

Depending on the specific facts that an investigation uncovers, a Boston Essure attorney may also consider theories of negligence, breach of warranty, or fraudulent misrepresentation. Fraudulent misrepresentation occurs if there are false representations of material fact that are made knowingly, intending to induce reliance, and a victim is injured due to that reliance. For example, if Bayer knowingly made misrepresentations of material fact about the risks of Essure and claimed that it was safe to use to induce consumers to have it implanted, and people relied on those misrepresentations and were injured, Bayer may be liable for fraudulent misrepresentation.

If you are able to establish the manufacturer's liability for injuries arising from Essure, you may be able to recover compensatory damages. These are damages intended to make you whole, and they can include economic and noneconomic damages. Economic damages can include past and future lost wages, past and future medical bills, and out-of-pocket costs. Noneconomic damages can include pain and suffering, mental anguish, and loss of consortium.

If you believe that you were injured by Essure or another defective medical device, such as transvaginal mesh, you should consult an experienced product liability attorney. In Massachusetts, you must bring your product liability lawsuit within three years from when you were injured. The Naumes Law Group represents people in Boston, Springfield, Worcester, Waltham, Watertown, Hyannis, Malden, Medford, Taunton, Peabody, Braintree, Weymouth, Quincy, Pittsfield, and Plymouth, as well as other areas of Suffolk, Middlesex, Barnstable, Berkshire, Bristol, Essex, Franklin, Hampden, Hampshire, Norfolk, Plymouth, and Worcester Counties. Contact us at 844-826-8445 or via our online form.