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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Breast Implants

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Citation:

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.

Questions

  1. 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?
  2. 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?
  3. Do the regulations specify who at the facility is responsible for inquiring whether the patient has breast implants?
  4. What criteria will FDA use to determine that facilities meet the MQSA requirements for dealing with patients with breast implants?
  5. Is a facility required to use any specific implant displacement technique when imaging patients with breast implants?
  6. 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?