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For women seeking permanent sterilization, a product known as Essure can provide the desired result without requiring the invasive procedure of a tubal ligation. The product, manufactured by Bayer, contains a set of tiny stainless steel coils placed in the fallopian tubes, which are held in place by scar tissue as they heal. This tissue also blocks eggs from being released.
Essure, like other medical devices, poses certain risks. Thousands of Essure recipients have filed defective medical device claims against Bayer, citing problems such as pain, device migration, and organ perforation. Medical device manufacturers have the responsibility to protect their users from harm by taking reasonable care to eliminate injury risks and warn users about any side effects or other potential problems that can arise. When a medical device manufacturer does not take this care, it is negligent and may be liable for injury damages.
Defective medical device cases can be complicated. Although manufacturers are liable for a victim’s injuries resulting from use of their faulty products, the doctors who prescribe these products can also be liable by not fulfilling their duties. These duties include warning the patient about all potential side effects and obtaining informed consent prior to each procedure.
In addition to the physical risks listed above, some of the lawsuits allege that not enough information is available as to what makes a woman a good candidate for the device. Before a physician performs a procedure on a patient, they must warn the patient of all potential risks and side effects, including a discussion about specific risks based on their medical history or background.
Some women who received Essure experienced no side effects while others faced difficulties that required them to undergo hysterectomies. The Food and Drug Administration (FDA) required Bayer to conduct further studies about Essure’s safety to determine the complications that accompany Essure versus tubal ligation in greater detail.
Although some of the victims involved in the case have called for Bayer or the FDA to take Essure off the market, the FDA is hesitant to do so because of the important benefits Essure provides. For the women who do not experience complications with the device, it provides a valuable form of non-invasive permanent birth control.
After more than 14,000 complaints about the device, the FDA did require Bayer to update Essure’s packaging to include more information about its potential risks. Although a spokesperson claims that this should be sufficient to warn users of the risks, some former users are skeptical.
A defective drug or medical device can leave a victim suffering from permanent injuries, large medical expenses, and may limit their ability to work again. Individuals in this position can seek compensation for their damages through defective medical device claims. To learn more, complete our online contact form or call 800-369-0899 or 215-569-4000 to set up your initial consultation with our team of Philadelphia medical product liability lawyers at Brookman, Rosenberg, Brown & Sandler. Our office is located in Philadelphia and we serve clients throughout the Delaware Valley, including those in New Jersey and Pennsylvania.