FDA Warns Coatings on a Medical Device Could Pose Health Risks

The human body is made up of as much as 65 percent water, which is why it’s crucial that many medical devices that are implanted into the body have a hydrophilic or hydrophobic coating. However, the Indiana personal injury lawyers at Fleschner, Stark, Tanoos & Newlin point out that records show many of these coatings can separate from the device, causing patients serious harm.

In 2010, the U.S. Food and Drug Administration (FDA) initiated the first recall of medical devices that were found to have a waterproof or water resistant coating peel off. Since that time the number of such claims have skyrocketed. According to an article from Medscape, the agency received 500 reports of coatings separating from medical devices last year alone.

The results of these coatings peeling away can be deadly as well. There have been at least nine deaths linked to a defective medical device that was known to have hydrophilic or hydrophobic coatings that can peel away. Even more patients have suffered serious injuries as a result of these separations.

These accidents prompted the FDA to request that anyone who has been harmed as the result of the coating peeling off of a medical device to report the incident to the agency.

The legal staff at Fleschner, Stark, Tanoos & Newlin have seen first hand the devastating results the use of a defective medical device can have on the user, and we’re hopeful the actions being taken by the FDA will protect the public from the risks of the coating on medical devices peeling away.