Silicone breast implants, metal rods to stabilize broken bones, heart valves made from the tissues of pigs and cows—modern medical technology is continually developing devices to implant in human bodies to improve health, quality of life, or appearance.
While these innovations are tested rigorously before being approved by the U.S. Food and Drug Administration (FDA) before being allowed on the market, there are always issues that cannot be addressed without observing long-term use in a large number of people.
Hence, the FDA develops protocols for and monitors post-market studies on devices that, while mostly safe for most patients, according to the agency, can have adverse effects on some people. This could be because of allergies or sensitivities, the design of the device, placement in the body or material used.
Determining and monitoring them is the purpose of a continuing FDA effort defined March 15 in a statement issued by the agency’s Commissioner Dr. Scott Gottlieb and its director of the Center for Devices and Radiological Health Dr. Jeff Shuren.
The continuing effort to collect data from patients, doctors, manufacturers and others includes looking at what might account for adverse reactions to some devices in some patients, the statement said.
The agency issued guidance related to the implantation of animal tissues in the human body. While these can be more easily used by the body in some instances, they also carry a risk of infection, such as by infectious agents known as prions that produce mad cow and similar diseases. The FDA made recommendations on how to lessen that risk while still allowing patients the benefit of animal-derived devices.
Risks associated with breast implants—which all have a silicone shell but can have different textures and fillings—will be the subject of a two-day public meeting Monday, March 25 and Tuesday, March 26 of the agency’s General & Plastic Surgery Devices Panel.
Later this year in the fall, the FDA will hold an advisory panel meeting to discuss risks associated with metal implants, which encompass a range of materials and devices. Reducing risks can include better evaluation of what patients might be sensitive to certain metals, determining whether the placement in the body influences the appearance and/or extent of side effects, whether long-term use leads to excessive accumulation of metals in the bloodstream, and more.
