Findings of the North American Breast Implant Registry

V. Leroy Young, MD

NATIONAL BREAST IMPLANT REGISTRY

PURPOSE: To report upon the two-year results of the National Breast Implant Registry (NaBIR)

MATERIALS & METHODS: NaBIR was founded by the Plastic Surgery Educational Foundation (PSEF) in July 2000 to concurrently collect data on the patterns of use and reasons for re-operations associated with breast implants. The scope of the registry was expanded in May 2002 when the International Breast Implant Registry was formed. Currently, there are 34 sites entering data in NaBIR and four countries participating in the international registry. Participation in the international registry is expected to increase because the European Parliament recently mandated tracking and registries for breast implants. Data collected by NaBIR include the type of implant, position of implant, incision site, manufacturer, and indications for operations. Additional information on tumor detection and staging has been added at the request of the FDA. The registry is voluntary and data submitted is anonymous, protecting the patient and surgeon's confidentiality. PSEF controls access to the data, which is stored at Data Harbor, Inc.

RESULTS: As of June 2003, 8393 implants had been entered into the registry. Ninety-nine percent (99%) of these implants were saline filled and 1% were silicone gel filled. Six thousand six hundred forty-eight (75%) were placed in a subpectoral position and 2,225 1,809 (25%) subglandular position. The inframammary incision was used most commonly (5,901 (68%)) followed by peri-aerolar (1,479 (17%)) and axillary (930 (11%)). The transumbilical approach was used in only 16 cases and a mastectomy scar in 301 (3%). The two major manufacturers dominated the market with one representing 52% of the implants used and the other 48%.

The registry also tracks indications for explantation. During the first two years, 883 explants were entered into the database. Request for change in size was the most common indication for explantation (307 (35%)) followed by capsular contracture (275 (31%)), rupture 260(29%), patient request (205(23%)), implant displacement (46 (5%)). In the fall of 2002 the registry began collecting data on skin wrinkling (11 (1%)), abnormal feel (10 (1%)), and pain (14 (1%)). To date, only two breast cancers have been reported.

CONCLUSION: The National Breast Implant Registry is working well, and useful data are being obtained on the pattern of usage of breast implants and the indications for explantation. The fact that change in size is the most common indication for explantation sends a clear message that surgeons need to do a better job of discerning what patients want preoperatively. As the number of implants entered and the length of follow-up increases, we will develop excellent data on the rate of implant rupture and the frequency of breast malignancies in implanted women. Participation in NaBIR by all members is strongly encouraged.