SILICONE GEL BREAST IMPLANTS

Plastic and Reconstructive Surgery: Volume 114(5)October 2004pp 1252-1257 Decision and Management Algorithms to Address Patient and Food and Drug Administration Concerns Regarding Breast Augmentation and Implants [COSMETIC SECTION: COSMETIC]

To further improve and widen the scope of the decision and management algorithms, we (Tebbetts and Tebbetts) sought the input and expertise of the other authors of this article. To address patient and Food and Drug Administration concerns, the Breast Augmentation Surgeons for Patients Initiative (BASPI) focused on a single objective: reducing reoperation rates in breast augmentation. The participants who coauthored this article each prepared extensively by developing and submitting alternative decision and management solutions for each topic listed. During 2 days of intensive workgroup sessions and follow-up communications to verify revisions, key contributions from all participants' solutions were integrated to derive the final algorithms presented in this article.

The effort by this joint workgroup of plastic surgeons with diverse backgrounds and experiences was to develop decision and management algorithms to assist in reducing reoperation rates in breast augmentation and improve patient outcomes. All templates are optional, additional resources for surgeons to consider when addressing the specific clinical topics.

The Surgeons for Patients Initiative materials and solutions are designed to codify and present information and alternatives to make repetitive decision-making processes more efficient by defining templates for management that have proved effective in long-term clinical experience. Basic management templates allow surgeons to focus on more detailed specifics of each clinical situation and, it is hoped, improve reoperation rates and outcomes. The Initiative provides defined solutions that prove to patients, the Food and Drug Administration, and patient advocacy groups that defined alternatives and solutions exist to address their concerns regarding causes of reoperations.

These decision and management algorithms are not intended to define standards of practice. The templates are intended to delineate a set of options available to patients and surgeons, not to define or limit surgeons' or patients' choices. No component of any algorithm is intended to supplant any area of a surgeon's clinical decision making. These decision and management algorithms cannot and do not address all of the variables that may exist in any clinical situation, and in every situation they must be adjusted by the surgeon to fit the clinical issues

All decision and management algorithms assume that the surgeon has obtained all pertinent baseline historical and medical background information pertaining to the clinical situation. Addressing the clinical options available to the patient and surgeon for optimal decision making and the requirements of informed consent requires the level of complexity presented in the algorithms. To limit complexity, the algorithms are not intended to address the management of unanticipated findings during surgery.

Conclusions

Defined management algorithms have proved invaluable to a wide range of businesses and professionals by optimizing business practices and addressing issues and problems. The decision and management algorithms presented in this article have been used successfully for 7 years in a busy breast augmentation practice, and they have been further expanded and refined by surgeons with a wide range of experiences and expertise to address the following issues and concerns that have been expressed by patients and the Food and Drug Administration: implant size exchange, grade III or IV capsular contracture, infection, stretch deformities (implant bottoming or displacement), silent rupture of gel implants, and undefined symptom complexes (connective tissue disease or other).

REFERENCES

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2. U.S. Food and Drug Administration. General and Plastic Surgery Devices Panel meeting transcript. Washington, D.C., February 18, 1992.

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7. Tebbetts, J. B.Patient acceptance of adequately filled breast implants. Plast. Reconstr. Surg. 106: 139, 2000.

8. Tebbetts, J. B. Dual plane breast augmentation: Optimizing implant-soft-tissue relationships in a wide range of breast types. Plast. Reconstr. Surg. 107: 1255, 2001.

9. Tebbetts, J. B. Achieving a predictable 24-hour return to normal activities after breast augmentation: Part II. Patient preparation, refined surgical techniques, and instrumentation. Plast. Reconstr. Surg. 109: 293, 2002.

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©2004American Society of Plastic Surgeons

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