The General and Plastic Surgery Devices Panel met on March 1-3, 2000 at the Gaithersburg Holiday Inn at Two Montgomery Village Avenue in Gaithersburg, Maryland. The panel met in order to provide advice and recommendations to the Agency for 3 premarket approval applications and to give advice on labeling and patient informed consent materials for women contemplating the use of saline-filled breast implants.
The meeting began with Mr. Phil Phillips (Deputy Director, ODE) giving the panel an update on the current understanding of the Least Burdensome provisions of the FDA Modernization Act of 1997. This was followed by public testimony from 37 scheduled individual consumers, consumer groups, consumer information providers and professional societies. Following the public testimony, Dr. Celia Witten (Director, DGRD/ODE) brought the panel up to date in regards to the Regulation of Saline-Filled Breast Prostheses. During this presentation Dr. Witten highlighted the history of the regulation of saline-filled breast implants and the guidance documents that FDA has prepared for the manufacturers of these medical devices. She further pointed out that these guidance documents identify the types of chemistry, toxicology, and mechanical testing recommended by the agency and also the types of clinical data that should accompany a premarket approval application for saline-filled breast implants. The final presentation before panel consideration of the PMAs was by Dr. Wendie Berg of the University of Maryland who is a consultant to the Radiological Devices Panel. Dr. Berg discussed Considerations on Imaging Patients with Breast Implants. She focused on the goals of mammography and the difficulties associated with mammography of the breast for women with breast implants. The important fact was that a great deal of the breast tissue is obscured by the implant thus making cancer detection more difficult.
The last order of business on the first day of the panel meeting was for discussion and recommendations on the PMA application for Mentor Corporation’s Saline-Filled Breast Prostheses. The Breast Prostheses are silicone elastomer shells, which are filled with sterile saline at the time of surgery. The focus of the panel discussion was on the preclinical and clinical data submitted by the sponsor. The Panel was asked to provide recommendations and advice to the FDA on this application.
The sponsor presentation highlighted the results obtained from a number of clinical studies. The data presented was from the Surveillance Epidemiology and End Results (SEER) Program of the National Cancer Institute, the Large Simple Trial (LST), the Saline Prospective Study (SPS) and the Mentor Retrospective Study. The discussion focused on the prospective SPS study, which was implemented at many centers in the US. This was an open label, prospective study with 3-year follow-up data. Safety was determined by the assessment of complications and effectiveness was assessed by the determination of breast dimensions, patient satisfaction and Quality of Life measures. The study enrolled 1265 patients undergoing breast augmentation with the implantation of 2528 implants and 428 patients undergoing breast reconstruction with the placement of 589 implants. The 3-year follow up was completed by 76.3% of the augmentation patients and 75.5% of the reconstruction patients. The cumulative rate of a first occurrence of any complication was 43% for augmentation patients and 73% for reconstruction patients at 3 years as assessed by Kaplan-Meier statistical analyses. The panel voted 9 to 1 to recommend approvable with conditions. The conditions included a requirement that Mentor Corporation work with FDA to complete and update the mechanical testing, that Mentor continue to collect long-term follow-up data, that Mentor perform further statistical analyses of the data, and that all efforts be made to fully inform patients of all potential risks associated with the use of breast implants.
During the second day of the meeting the panel considered PMA applications from McGhan Medical and Poly Implant Prostheses (PIP). The McGhan Medical discussion included a review of their preclinical and clinical data. The panelists agreed that except for fatigue and fold-flaw testing, McGhan had successfully completed all of their preclinical testing. The major portion of the discussion focused on the clinical data supplied by McGhan Medical in regards to their open label, prospective study, which proposed 5-year follow-up and had completed 3-year follow-up for most patients and 4-year for many patients. This study assessed safety by determination of complications and assessed effectiveness by monitoring breast size, patient satisfaction and Quality of Life measures. The study had two arms, one for augmentation patients and one for reconstruction patients. The augmentation arm of the study enrolled 913 patients undergoing and included the placement of 1800 devices. The reconstruction arm of the study enrolled 256 patients and included 316 devices implanted. Both augmentation and reconstruction patients were generally satisfied with their surgeries. The four-year cumulative rate of a first occurrence of a complication was 60% for the augmentation patients and 84% for the reconstruction patients by Kaplan-Meier analyses. The panel voted unanimously to recommend approval with conditions for this PMA. Some of the conditions were that the sponsor continue long-term follow-up, to revise the risk characterization in reconstruction, and to include literature information.
The panel discussion of the PMA application for Pre-filled Saline Breast Implants from PIP focused on the difficulty of assessment of these devices based on incomplete data for both the preclinical and clinical aspects of their product. The discussion of the clinical study focused on a French Clinical Study and a U.S. Discretionary Postmarket Surveillance (DPS) study. The panel members felt that the French Clinical Study could not be used as a stand alone study and the data from US study was needed to gain a greater understanding of the safety and effectiveness of the PIP implants. There was little two year follow-up data available from the US DPS study. The panel voted unanimously to recommend that this PMA was not approvable. The panel members stated that the major factors in their recommendation were that the preclinical and clinical data were not complete.
The final day of the panel meeting focused on the type of information that should be available to women considering breast surgery for breast augmentation and/or breast reconstruction. This included information that was to be placed into the labeling intended for the patient, the labeling intended for the physician, and also the information that would go into the informed consent documentation. The panel members were asked to comment and provide specific suggestions on important information to include in these documents and the form that this information should take, to comment on whether a waiting period would be appropriate in order to provide the patient with adequate time to make an informed decision, to comment on postoperative symptoms that should cause patients to seek medical consultation, to discuss the types of information patients should be given regarding differences in surgical procedures and postoperative care and to discuss other elements that should be added to patient information. The general consensus of the panel was that patient labeling should include as much information as possible to address all possible risks and complications with information on expected outcomes. The information should also be focused on product specific data.
David Krause, Ph.D
General and Plastic Surgery Devices Panel
(301) 594-3090 ( x141)
Transcripts may be purchased from
Neal R. Gross & Company
1323 Rhode Island Avenue, NW,
Washington, DC 20005,
phone: 202-234-4433; FAX: 202-387-7330
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
301-827-6500 (voice) or 301-443-1726 (FAX)