Medical devices containing chemical bisphenol A (BPA) — such as dialysis tubing, blood oxygenators and dental sealants — are on the FDA’s radar screen and are increasingly becoming an area of concern for consumers and industry.
The FDA will publish a report assessing the safety of exposure to BPA from regulated medical devices, biologics and pharmaceuticals, FDA spokesman Michael Herndon said.
Until recently, devices have not been part of the conversation of whether BPA levels in FDA-regulated products are safe.
This document comes on the heels of an evaluation examining migration of BPA from food contact materials. Concerns have arisen over the chemical since it has been found to migrate in small amounts into foods and beverages stored in the material, and some recent animal studies have indicated that high levels of BPA could be carcinogenic.
BPA is also used in packaging materials, such as polycarbonates for water bottles, drinks and baby food bottles, and in epoxy resins for internal protective linings for canned goods and metal lids.
Previous reports by the US National Toxicology Program and Environmental Working Group have shown links between BPA and cancer.