Metals, Other Materials in Medical Devices May Be Causing Hypersensitivity and Inflammatory Reactions, FDA Warns

Medical devices may be causing certain individuals to experience hypersensitivity and inflammatory reactions due to certain metals and other materials in products like breast implants, birth control implants and metal-on-metal hip replacement systems, according to federal health officials.

On March 15, FDA Commissioner Scott Gottlieb and Dr. Jeff Shuren, director of the Centers for Devices and Radiological Health issued a statement indicating the FDA was reviewing a number of materials that may be behind adverse reactions to certain medical device implants, and announced an upcoming advisory committee hearing to address the issue.

“Based on our evaluation and discussions with experts elsewhere in the government and academia, we believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune/inflammatory reaction when exposed to selected materials,” they wrote. “The symptoms some patients experience may be limited to the region where the device is implanted or may be more generalized.”

The symptoms of these reactions can include fatigue, rash, and joint and muscle pain or weakness, the statement indicates. However, those symptoms may not develop until several years following implantation, according to the warning.

The agency suggests these types of reactions to certain materials may be behind illnesses and cancer cases linked to breast implants, adverse reactions to nitinol in Bayer’s Essure implant, complications linked to metal-on-metal hip replacement systems and other devices.

A number of these products have either been severely restricted or removed from the market completely. Once a major portion of the hip implant market, all metal-on-metal hip designs have been removed from the U.S. market either through recalls or decisions by manufacturers that they were not worth the trouble. The FDA warning indicates there are currently no metal-on-metal hip implants approved for use in the United States.

In addition, Bayer removed all Essure birth control implants from the market in December. Although it claims it was a marketing decision, the manufacturer removed the implants from markets worldwide as regulatory agencies raised concerns and placed restrictions on the implants’ use.

FDA officials have reported that the agency received about 12,000 adverse event reports related to the Essure birth control implant last year. In April, the FDA made changes to Essure’s premarket approval, requiring both doctors and patients to sign off on a checklist of potential Essure complications.

Bayer currently faces more than 18,000 Essure lawsuits filed by women nationwide, each involving similar allegations that the birth control device left them with severe and devastating injuries.

Breast implants, however, are currently still on the market, and the FDA and other regulatory agencies worldwide are still unraveling the causes of what have become known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a form of cancer linked to textured breast implants. However, in addition to cases of BIA-ALCL,  doctors are indicating they are seeing increasing cases of “breast implant illness,” commonly involving chronic side effects, such as fatigue, cognitive problems, muscle and joint pain, hair loss, infections, gastrointestinal problems, rashes and thyroid issues. In many cases, the problems have led women to have their breast implants removed, and concerns about the risk have become a factor many are questioning whether to undergo breast enhancement or reconstruction surgery.

FDA Investigation

Gottlieb and Shuren say the agency has been evaluating the evidence on these hypersensitivity and inflammatory reactions. That evidence includes current studies, adverse event reports, and is being studied by the Center for Devices and Radiological Health’s Office of Science and Engineering Laboratories.

However, they note that because the symptoms may not develop for several years, those reactions could be missed by clinical studies.

“Enhancing our collective understanding of materials science could lead to identifying materials that may cause an exaggerated response in sensitive individuals and advance the development of safer matererials,” Gottlieb and Shuren wrote. “Development of new tests to identify at-risk patients would help ensure they do not receive implantable devices that contain the material to which they are sensitive, therefore further enhancing patient safety and advance a precision medicine approach to the selection of devices interventions.”

The statement indicates the FDA will begin an effort to engage the public, scientists, and manufacturers to gather information on the current state of the science and find critical gaps that need to be addressed, as well as determine the correct approach to increase the agency’s understanding of medical device materials.

As part of that effort, they indicated the FDA will hold an advisory committee meeting this fall to discuss metal implants and the risks of patient hypersensitivity or immune and inflammatory reactions. Before the meeting, which has not yet been scheduled, the FDA will issue a peer-reviewed white paper summarizing the agency’s current knowledge on metal implants and how they react with the body.