September 24, 2018
- Patients who had mammograms at Aims Diagnostic Imaging located in Manahawkin, New Jersey any time on or after June 15, 2017.
- Health care providers who have referred patients to Aims Diagnostic Imaging located in Manahawkin, New Jersey, for a mammogram performed on or after June 15, 2017.
Primary Care, Family Medicine, Internal Medicine, Obstetrics and Gynecology, Radiation Oncology, Radiology, General Surgery, Breast Surgery
A mammogram is a safe, low-dose X-ray picture of the breast for detecting breast cancer in its early, most treatable stages. It is currently the most effective method of screening for breast cancer to detect it in its early, most treatable stages.
The FDA is alerting patients who had mammograms at Aims Diagnostic Imaging located in Manahawkin, New Jersey, on or after June 15, 2017, about possible problems with the quality of their mammograms. This does not mean the results of the mammograms were inaccurate, but it does mean that health care providers and patients should consider having these mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if a repeat mammogram or additional medical follow-up is needed.
Summary of Problem or Scope
The FDA became aware of potential problems with the quality of mammograms performed at Aims Diagnostic Imaging located at the following address:
1109 Beacon Ave
Manahawkin, NJ 08050
The results of this facility’s annual MQSA inspection indicated that required quality control tests were not performed after June 15, 2017. As a result, the FDA notified the facility that it was required to undergo an Additional Mammography Review to determine if the overall quality of mammography performed at the facility was compromised due to the failure of the facility to operate in compliance with the MQSA, and whether there was a need to notify affected patients.
After Aims Diagnostic Imaging repeatedly failed to submit the mammograms needed to perform the Additional Mammography Review, the American College of Radiology, this facility’s accreditation body, revoked the facility’s accreditation on September 17, 2018 for failing to comply with the Additional Mammography Review order.
The MQSA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility failed to meet the quality standards of the MQSA. On September 19, 2018, the FDA placed the facility’s MQSA certificate in a “no longer in effect” status. This facility can no longer legally perform mammography as it does not have an active MQSA certificate.
The FDA recommends the following for patients who had a mammogram at Aims Diagnostic Imaging any time on or after June 15, 2017:
- If you have had a more recent mammogram at a different MQSA-certified facility since then, you should follow the recommendations from that facility.
- If you have not had a mammogram at a different MQSA-certified facility since then, follow these guidelines:
- 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 or possible 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 an MQSA-certified facility in your area.
Patients or their representatives have the right to request their mammograms and copies of their medical reports from Aims Diagnostic Imaging.
The FDA will continue to monitor this issue and keep the public informed as new information becomes available.
If you have questions about this communication, please contact the MQSA Hotline by phone: 1-800-838-7715, email: MQSAhotline@versatechinc.com or fax: 1-443-285-0689.