FDA To Evaluate Medical Devices Causing Adverse Reactions

FDA To Evaluate Medical Devices Causing Adverse Reactions

Introduction

FDA Commissioner, Scott Gottlieb, and Dr. Jeff Shuren, director of the Centers for Devices and Radiological Health, issued a statement on March 15, medical devices might be causing hypersensitivity and inflammatory reactions to certain individuals due to the presence of certain metals and other materials in the products like breast implants, birth control implants, and metal-on-metal hip replacement devices.

According to the federal health officials, the FDA was reviewing a number of materials that might be responsible for the harmful side-effects and announced that the issue must be addressed at an upcoming advisory committee hearing. The warning stated that the symptoms of adverse reactions can include fatigue, muscle pain, rashes or inflammation; however, some symptoms may not appear for several years after the implantation. The agency suggested that these reactions might be the reason for a certain type of illnesses and cancer linked to breast implants, adverse effects to nitinol in Bayer's Essure implant, and complications related to the metal-on-metal design of the hip replacement devices like Zimmer’s Durom Cup. Bayer took off all Essure birth control implants from the market in December 2018, and although it claimed that it was a marketing decision, regulatory agencies had imposed restricted use on those implants due to its safety issues. The FDA indicated there are no metal-on-metal hip implants approved for use in the U.S. The FDA officials told an advisory committee meeting would be held this fall, to discuss metal implants and their associated risks in developing hypersensitivity and inflammatory reactions in patients.