Mammography Quality Concerns Prompt FDA Intervention at North Jersey Imaging Facility

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Mammography Quality Concerns Prompt FDA Intervention at North Jersey Imaging Facility

May 27

On May 21st, the US Food and Drug Administration (FDA) issued a “Safety Communication” regarding Advanced Women’s Imaging (AWI), located in Guttenberg, NJ. Patients who had mammograms performed at AWI anytime on or after March 11, 2020 are being made aware of possible problems with the quality of their mammograms.

Potential Medical Malpractice from Faulty Mammograms

The results of the FDA’s annual Mammography Quality Standards Act (MQSA) Inspection at AWI revealed that required quality control tests were not performed between March 11th and August 25th (2020), compromising the quality of mammograms performed during that period of time and after. This failure to operate in compliance with MQSA forced the FDA to notify affected patients.

Additionally, AWI failed to comply with an Additional Mammography Review order by not submitting the required mammograms. As a result, the facility lost its accreditation by the American College of Radiology on September 12, 2020.

Because the facility is non-compliant with MQSA and has lost its accreditation, the facility can no longer legally perform mammograms.

I Received Mammography Imaging Services at Advanced Women’s Imaging after March 11, 2020 – What do I do Now?

The FDA has the following recommendations for anyone who had a mammogram at AWI on or after March 11, 2020 and has not had a mammogram at any other MQSA-certified facility since then:

Talk with your health care provider as soon as possible about your medical follow-up. You may need your mammogram re-evaluated, and possibly need a repeat mammogram for further evaluation.
If your health care provider recommends a repeat mammogram, it should be done at an MQSA-certified facility. A database of MQSA-certified facilities in your area is available online, or you can call the National Cancer Institute’s information number at 1-800-422-6237 to find and MQSA-certified facility in your area.

New Jersey and Philadelphia Medical Malpractice Attorneys

The lack of responsibility Advanced Women’s Imaging displayed in their failure to comply with MQSA regulations could have disastrous results for patients who depended on their abilities to provide accurate imaging to physicians. A medical malpractice attorney can step in if the consequences are dire. The medical malpractice attorneys at Messa & Associates are experienced in handling complex medical malpractice cases, including but not limited to missed diagnoses, MRSA infections, surgical site infections, foreign objects, and treatment errors/negligence. If you or a loved one has fallen victim to medical negligence at a hospital, nursing home, imaging, or rehab facility, act quickly. Call a medical malpractice attorney from Messa & Associates today, before your rights to legal compensation have expired. Call 877-MessaLaw for a free consultation or submit an inquiry online for a free case evaluation.

About the Author

Angela serves as the Director of Marketing and Public Relations at Messa & Associates, handling all aspects of marketing, social media, and press relations. aleone@messalaw.com