900.12(g)(1)(2): Mammographic procedure and techniques for mammography of patients with breast implants.
(1) Each facility shall have a procedure to inquire whether or not the patient has breast implants prior to the actual mammographic exam.
(2) Except where contraindicated, or unless modified by a physician’s directions, patients with breast implants undergoing mammography shall have mammographic views to maximize the visualization of breast tissue.
- Is a facility required to accept patients who have breast implants for mammographic examinations? If not, must the facility refer patients with implants to another facility that provides implant imaging services?
- Can a facility inquire whether the patient has a breast implant at the time the appointment is being made, or immediately prior to the actual mammographic examination?
- Do the regulations specify who at the facility is responsible for inquiring whether the patient has breast implants?
- What criteria will FDA use to determine that facilities meet the MQSA requirements for dealing with patients with breast implants?
- Is a facility required to use any specific implant displacement technique when imaging patients with breast implants?
- Is there a specific amount of training or number of mammograms of breast implant patients that the technologist must perform under direct supervision prior to performing these studies independently?