FDA yanks imaging facility’s mammography accreditation following quality issues
The U.S. Food and Drug Administration recently pulled a Virginia breast imaging center’s mammography certification after an official review revealed quality deficiencies in its exams.
According to a Sept. 25 safety communication, the agency said it has yanked Allison Breast Center’s Mammography Quality Standards Act certificate after it failed to comply with regulations set forth in the Mammography Quality Standards Act of 1992. The move has been in effect since Aug. 11, according to the FDA.
Patients seen at the Monument Radiology affiliated practice on or after June 17, 2018, may have problems with their mammograms. The FDA recommends contacting Allison to obtain medical report copies and suggests patients have their mammograms read by outside physicians.
Problems at the breast care center began in May after the Virginia Board of Medicine suspended Michael Bigg’s medical license. In a 61-page report, the board found Bigg—the doctor and owner of the facility—wrongly interpreted 18 mammograms, labeling him “incompetent to practice medicine and surgery.”
As many as seven patients have since found out their exams were misread. Bigg, who is facing a civil lawsuit, has denied such allegations.
His wife, Gillian Bigg, penned a lengthy note regarding the closure:
“We are truly so sorry that you have had to go through this and are heartbroken by any negative feelings that may have resulted from this. We always felt our patients and staff were like family to us and still feel the same way.”
Regarding Bigg, she wrote the following:
“He [Bigg] has still not been able to clear his name and still does not have an appointment with the board to do so. After 40 years as a radiologist, saving thousands of patients’ lives, this is his first incidence of anything like this.
This was a huge shock to both myself and my husband and am sure to all of you. As you can imagine, this has been difficult for all of us here at Allison Breast Center, and we ask you for your grace and patience.”
Read more about the situation here.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.