Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers recommending providers discuss alternative options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures with patients if a facility is unable to perform the biopsy due to the shortage of Philips Invivo MRI breast biopsy grid plates or other Philips Invivo MRI coil disposables.

The Letter to Health Care Providers includes important information about the shortage of Philips Invivo MRI breast biopsy grid plates and other MRI coil disposables, including:

• Recommendations for health care providers.
• Actions that the FDA has taken to address the shortage of Philips Invivo MRI breast biopsy grid plates and other MRI coil disposables.
• Instructions for reporting problems and supply chain issues to the FDA.

In addition, the FDA has added certain product codes associated with MRI breast biopsy grid plates to the medical device shortage list.

Questions?

See Supplies of Medical Devices for COVID-19: Frequently Asked Questions web page.

If you have questions about this letter to health care providers, contact the Division of Industry and Consumer Education (DICE)