General and Plastic Surgery Devices Panel - July 8 and 9, 2002
The General and Plastic Surgery Devices Panel (GPS Panel) met on July 8 and 9, 2002 in the Ballroom of the Gaithersburg Holiday Inn located at 2 Montgomery Village Avenue in Gaithersburg, Maryland to provide advice and recommendations to the Agency for the classification of silicone elastomer for scar management, for the reclassification from Class III to Class II of the absorbable hemostatic agent and dressing devices, and in regards to an update of the conditions of approval for the approved saline inflatable breast implants.
On July 8, the meeting consisted of a brief closed session and an open session. During the closed session, Mr. Stephen Rhodes (Acting Deputy Director, DGNRD) gave the Panel Members a briefing on some of the devices they may be providing advice and recommendations on over the next few years.
After a short recess, the open portion of the panel meeting began at 1:30 pm with Mr. Anthony Watson (Acting Branch Chief, PRSB/DGRND) updating the committee on events related to panel activities that had occurred since the panel last met in July of 2001. In his update, Mr. Watson indicated that FDA had acted on the GPS Panel’s recommendation of approval for Ortec’s OrCel bilayered Cellular Matrix and had approved the product on August 31, 2001. Mr. Watson also stated that the Agency had approved a PMA for Lifecore’s Intergel® Adhesion Prevention Solution on November 19, 2001. This application had been reviewed by the GPS Panel at its January 2000 meeting and was recommended as not approvable. The Agency agreed and, after receiving a not approvable decision, the sponsor requested review at the Medical Device Dispute Resolution Panel (MDDR Panel). The MDDR Panel met on September 6, 2001 and recommended that the application be approved. In continuing, Mr. Watson mentioned that the Agency released an updated guidance document entitled, "Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery."
The open session continued with a hearing on the classification of silicone elastomer for scar management and a hearing on the proposed reclassification of absorbable hemostatic agent and dressing devices from Class III to Class II. Following discussion, the panel voted to classify the silicone elastomer for scar management intended for use in the management of closed hyperproliferative (keloid and hypertrophic) scar disorder for regulation as a Class I device requiring submission of a premarket notification [510(k)] and to be dispensed on the order of a healthcare professional. The vote was 6 for and 1 abstention. The abstaining member indicated that she had abstained because she felt that making these products prescription would prevent distribution to those who could not afford medical care but might still benefit from the product.
The panel then proceeded to the discussion of the proposed reclassification of the absorbable hemostatic agent and dressing devices from Class III to Class II. Industry representatives from Johnson & Johnson Wound Management Worldwide, Ferrosan A/S, and Integra LifeSciences as well as FDA provided information attesting to the safe and effectiveness use of these devices for over 50 years. The consensus of opinion of the panel was that the product was appropriate for reclassification to Class II, but that they did not feel comfortable recommending such reclassification without first agreeing that the proposed special control, a guidance document, was appropriate to assure the continued safety and effectiveness of these products. Therefore, the panel voted 4 to 3 to table the discussion and vote on the proposed reclassification of absorbable hemostatic agent and dressing devices until said guidance document is deemed appropriate. The first day’s activities were concluded at approximately 5:20 pm.
The second day of the meeting consisted of a two hour open public comment period and sponsor and FDA presentations regarding the post-approval conditions of approval studies for the approved saline-filled breast prosthesis PMAs approved in May of 2000. During the open public comment period there was public testimony and/or statements read from 17 individual members of the public. The morning continued with sponsor and FDA presentations regarding the Mentor Saline-Filled Breast Implants. The sponsor and FDA presentations focused on the post-approval study, focus group study, retrieval study, fatigue testing, and shelf life testing conditions of approval. During these presentations, it was reported that Mentor had reported a 5% follow-up rate at 5 years in the post-approval study for patients enrolled into the study at this time. Several panel members expressed concern regarding this follow-up rate. This follow-up is to continue up until 10 years. It was reported that the Focus Group Study is complete and the findings have been used to modify the patient brochure. Some panel members indicated that FDA should consider closing the loop on the focus group study by seeking input on the revised patient brochure. The final report for the retrieval study is under FDA review. Fatigue testing is still due on Style 5000PT. Shelf life testing time zero data has been provided for a number of styles. Year zero data on Style 5000PT is under FDA review. Shelf life testing will continue for 5 years.
After lunch, sponsor and FDA presentations were made regarding the Inamed (formerly McGhan Medical) Saline-Filled Breast Implants. Again, the sponsor and FDA presentations focused on the post-approval study, focus group study, retrieval study, fatigue testing, and shelf life testing conditions of approval. During these presentations, Inamed reported an 80% follow-up rate at 5 years in the post-approval study, which is to continue up until 10 years of data has been collected. It was reported that the focus group study is complete and the findings have been used to modify the patient brochure. Some panel members indicated that FDA should consider closing the loop on the focus group study by seeking input on the revised patient brochure. The final report for the retrieval study is scheduled for submission to FDA in July 2002. All fatigue testing is considered complete. Shelf life testing time zero data has been provided and is considered adequate. Shelf life testing will continue for 5 years. The meeting was adjourned at approximately 3:00 pm.
Contact: David Krause, Ph.D., Executive Secretary (301-594-3090, x141)
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