FDA Announces Schedule for Saline Implant Data

On December 23, 1994, the Food and Drug Administration announced that it will issue a final rule calling for premarket approval applications from manufacturers of saline-filled breast implants in 1998. Prior to the PMA submis- sion deadline, manufacturers will be required to have provided pre- clinical data, as well as results of both an epidemiology study on rupture rates and a large, simple trial on complication rates, accord- ing to a three-year schedule (1995-1998) developed by FDA. The final marketing application will include three-year clinical data and quality of life assessments.

As part of their agreement with FDA, manufacturers will dissemi- nate to prospective patients, through their surgeons, updated patient information on saline-filled breast implants. The Aesthetic Society is among various health professional and consumer groups which were asked to assist FDA in developing these patient informa- tion materials. The Aesthetic Society's Immediate Response Committee on Breast Surgery has reviewed the FDA-prepared docu- ment and provided an official response.

Breast Implants Needed for Washington University Study

The Washington University School of Medicine and School of Engineering are jointly conducting a study of explanted breast implants to investigate how their mechanical, chemical and physical

properties may change over time as a result of exposure to a biolog- ical environment. Implants that have never been used, ranging in age from one to 20 years, are urgently needed to serve as con- trois. Information regarding the manufacturer and year of manu- facture is required, and all models of breast implants are welcome. In addition, the study will be assisted by receiving any explanted implants that are available, including infor- mation on the manufacturer, year of implantation and explantation, and relevant patient history. All materials may be sent to: V. Leroy Young, MD, Cosmetic Surgery Center, 1040 North Mason Road, Suite 206, St. Louis, Missouri 63141; or direct inquiries to telephone 314/878-0520 or fax 314/878-3118. Dr. Young repre- sents ASAPS on the F04.60 committee of the American Society for Testing and Materials.

Guest Lecturers Represent ASAPS

Scott Spear, MD and Glenn Jelks, MD were among surgeons repre- senting the Aesthetic Society as guest lecturers during the last quarter of 1994. Dr. Spear spoke at the New York Regional Society of Plastic and Reconstructive Surgery, and Dr. Jelks was a guest of the National Capital Society

of Plastic Surgeons. (Other guest lecturers for 1994 were listed in the summer and fall issues of Aesthetic Surgery Quarterly.) So far in 1995, guest lecturers slated for speaking engagements include Harvey Zarem, MD for the Rocky Mountain Society of Plastic Surgeons (Feb. 12); S. Anthony Wolfe, MD for the Colorado

Society of Plastic Surgeons (Feb. 23); and Joel J. Feldman, MD for the Southeastern Society of Plastic and Reconstructive Surgeons (June 3-7). For information on the ASAPS Guest Lecturer Program, contact the ASAPS Central Office, Education Department, at 310/595-4275.

3 0 A E S T H E T I C S U R G E R Y Q U A R T E R L Y - S P R I N G 1 9 9 5