Schmidt, Sethi & Akmajian Blog

Food and Drug Administration Issues Warning For Breast Implants

Posted by Matt Schmidt | Nov 08, 2019 | 0 Comments

Breast augmentation is the most popular form of plastic surgery in the country. Recently, however, the Food and Drug Administration has decided to issue a boxed warning and is considering requiring a decision checklist--a list doctors must go over with their patients--due to increased findings of complications, including pain, scarring, weakness, cognitive difficulties, rupture, autoimmune disease, blood cancer and even death. The FDA found that 1 out of 5 women have gotten their implants removed sooner than the recommended 8-10 year period due to complications. The FDA's decision comes after substantial criticism and lobbying by women that they were not adequately informed of these risks prior to getting the procedure.

With a few exceptions and due to Federal preemption laws, it is generally extremely difficult if not impossible to sue medical product and medication manufacturers whose products have been approved by the FDA and comply with labeling guidelines. That said, doctors still have legal and ethical obligation to thoroughly inform their patients of risks and complications that can occur from any given product, treatment, medicine or procedure. Unfortunately, some doctors have been inappropriately motivated to push products, medications or procedures without providing adequate information to their patients.  Whether it is a breast augmentation or some other form of medical treatment, it is critical that patients be proactive in their own care by making sure they have been fully informed and have had all their questions properly answered by their doctors.

About the Author

Matt Schmidt

Matt graduated from the James E Rogers College of Law at the University of Arizona in passing the Arizona bar exam in 2010. Matt's primary interest in law focuses on general personal injury and insurance bad faith.

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