FDA panel recommends adding stereotactic breast biopsy to quality standards program

November 7, 2007

An FDA advisory panel has voted to support a plan for mandatory accreditation for stereotactic breast biopsy under the Mammography Quality Standards Act program.

An FDA advisory panel has voted to support a plan for mandatory accreditation for stereotactic breast biopsy under the Mammography Quality Standards Act program.

Mammographers welcomed the 9-4 vote (one member recused himself) favoring accreditation Nov. 5 after testifying in favor of accreditation earlier in the day before the panel in Rockville, MD. Breast surgeons opposed the proposal.

The MQSA, the federally mandated breast imaging center accreditation program, does not cover image-guided breast biopsies and breast imaging technologies that do not use x-rays, such as MRI and ultrasound. The FDA has recently become open to discussing the merit of regulating stereotactic biopsies and other types of image-guided breast interventions with input from radiologists, surgeons, equipment manufacturers, and consumer advocates.

National Mammography Quality Assurance Advisory Committee (NMQAAC) members advised the FDA to lift stereotactic breast biopsy's exemption from current MQSA regulations, citing uneven quality standards in current clinical practice and radiation dose concerns. They also noted that participation in voluntary accreditation programs currently available has been conspicuously low.

NMQAAC members who voted against the measure said regulation would keep considerable numbers of physicians from performing these interventions and hurt breast cancer patients' access to care. They also cited lack of a documented need for regulation in the clinical literature and pointed out that the MQSA does not call for regulation of breast interventions.

Failure to perform stereotactic biopsy in a competent way can result in delayed or missed diagnosis of breast cancer and the need to remove larger volumes of breast tissue than otherwise necessary, said Dr. D. David Dershaw, a member of the American College of Radiology's Breast Imaging Government Relations Committee, who presented the ACR position at the public hearing.

Stereotactic breast biopsy should be included under federal regulation in order to maximize patient safety and effectiveness of the procedure, Dershaw said. Although the decision is not yet final, he expressed satisfaction with it.

"I simply hope that the FDA goes along with the recommendation," said Dershaw, who is also director of breast imaging at Memorial Sloan-Kettering Cancer Center in New York City.

Dr. Arthur G. Lerner, chair of corporate relations for the American Society of Breast Surgeons, testified in opposition to accreditation. He argued that credentialing should be a peer-reviewed procedure done locally without the federal government's involvement.

Including stereotactic breast biopsy will hamper medical practice by restricting surgeons' ability to perform this procedure, Lerner said. He predicted it would also exacerbate difficulties surgeons are already having in terms of offering this procedure to patients, who will be the ones to suffer the most.

Imaging equipment manufacturers sided with surgeons. According to Stephen Vastagh, industry director of the Medical Imaging & Technology Alliance Mammography Group, there are no data that indicate problems or errors related to stereotactic biopsy or other breast interventions in the unregulated environment. He asked the FDA to conduct studies that show evidence of such problems before ruling in favor of regulations.

"It is necessary to quantify how many procedures are performed and what percentage of those procedures is deficient. In other words, define the clinical need for regulation," he said.

Breast imagers do not look forward to yearly inspections, but they understand what can be achieved in terms of quality under regulation, said Dr. Carol H. Lee, president of the Society of Breast Imaging and chair of the ACR commission on breast imaging. Surgeons may not be used to or comfortable with external regulation, but if they are performing at the same level of quality as radiologists, they should not worry.

"I understand their concern, but our feeling is for facilities and practitioners already operating under high quality standards, the added burden of including stereotactic breast biopsy under MQSA is going to be minimal," Lee said.

For more information from the Diagnostic Imaging archives:

College, society drop out of surgeon-sponsored breast ultrasound accreditation program

Popularity of breast ultrasound raises questions of qualityy

Quality issue must move beyond mammography

Intervention widens breast disease options