FDA Adds Safety Summaries for Implant Materials Cobalt Chromium, Stainless Steel, Titanium

The FDA and ECRI (originally founded as the Emergency Care Research Institute) have published three new safety summaries for materials commonly used in implantable medical devices: cobalt chromium, stainless steel, and titanium.

The summaries focus on five key areas of local and systemic patient reactions to the materials: the typical response; any persistent or exaggerated responses; patient or material-related factors that may predict, increase, or decrease responses; and what research is needed to better understand responses.

The FDA said that the majority of patients implanted with medical devices have no adverse reactions, however some patients may have biological responses such as inflammatory reactions, tissue changes, pain and other symptoms that may interfere with their quality of life.

The FDA now lists 20 safety summaries, such as silver, hyaluronic acid, PET (polyethylene terephthalate) and polypropylene, and the agency intends to add to the list as new reports become available.