In order to help make medical devices easier to implant, a coating is often applied to the surface. Polyvinylpyrrolidone (PVP), silicone and Polytetrafluoroethylene (PTFE) make devices more maneuverable for surgeons, minimize the risk of blood clots and limit trauma to the patient. However, the coatings can potentially flake off of a device’s surface, leading to serious injury or even death.
Such complications have led the FDA to release safety warnings to healthcare providers so they are aware of the risks and can offer guidance on how to ensure the coatings remain intact.
Hydrophilic or hydrophobic coated devices have been used in the medical field for more than 20 years. The coatings help surgeons minimize risks by cutting down on the friction between the body’s blood vessels and devices like balloon and intravascular angioplasty catheters, implant delivery systems, delivery sheaths and guidewires.
Millions of people currently benefit from these implants.
Since January 2010, however, there have been 11 recalls on coated devices. Additionally, 500 Medical Device Reports (MDRs) filed since January 2014 have described coatings coming off of medical devices. At least 11 of the MDRs indicated a patient died, and of these 11, nine were mentioned in literature that became published. All of the cases involved coating particles coming off during brain or heart catheterization. No specific manufacturer or brand had a higher risk than another in these instances.
Currently, the benefits of these devices outweigh the risks associated with coatings coming off. Therefore, the FDA has not yet suggested that surgeons discontinue using coated devices.
Incurring an injury from a medical device intended to benefit your health is unacceptable. If you’ve been injured by a medical device and need help getting the compensation you deserve, schedule a free consultation with Gilreath & Associates.
If you would like further information about medical device failure and product liability, we encourage you to browse our blog and knowledge center.