Purpose:  This ongoing prospective study is following all primary augmentation patients of a single experienced surgeon to determine the prevalence of local complications and reoperations among women receiving saline breast implants. Data from the first five study years (1997-2001) are presented.

Methods:  Between Jan. 1, 1997 and Dec. 31, 2001, 287 consecutive patients (573 breasts) underwent primary augmentation with saline implants. They are being followed to collect data that includes patient variables (e.g., age at operation, pre- and postop weight, bra size); implant variables (e.g., type, volume, position, incision used); breast variables (e.g., pre- and postop measurements, pain, grades of contracture, ptosis, skin wrinkling, implant palpability); and aesthetic variables (e.g., patient satisfaction, surgeon evaluation). Along with compiling these data points, we are tracking all local complications, reoperations, and explantations to determine their frequency and possible causes. The study has no fixed endpoint.

Results:  Almost all the 593 implants are smooth, round devices manufactured by Mentor Corp. and placed in a submuscular position. An inframammary crease incision was used most often, followed by the transumbilical approach. Table 1 presents basic information on this primary augmentation group according to whether patients had a reoperation. A shortcoming of this series is the relatively short follow-up time. Even though patients are asked to return for follow-up evaluations, the vast majority do not unless they have an implant-related concern or desire another cosmetic procedure.

Ten percent of the 287 patients and 6.5% of the 573 breasts required reoperations ranging from minor in-office procedures to implant exchange to Wise pattern mastopexy. The number of revisional procedures was 39 (10 bilateral and 29 unilateral), at a mean time of 7.9 months after the previous surgery (range=0-34.3 months). Surgeries on 12 breasts (2.1%) were required to treat local complications: implant displacement=4, hematoma=3, implant extrusion=3 (in 2 patients), periprosthetic infection=1, and capsular contracture=1. Only one implant deflated and directly resulted from needle damage during a revisional procedure. Another 28 breasts (4.9%) were revised for cosmetic or other reasons unrelated to complications. Ptosis was corrected in 8 breasts with either a concentric circle or Wise pattern mastopexy or larger implants. Other reasons for reoperation included cosmetic revisions such as correcting size or position asymmetry (11 breasts), hypertrophic scar revision (2 breasts), or patient preference for a change (7 breasts). Only 1 patient requested a change in the size of her implants. Twenty-one implants were removed, with 15 replaced at the time of explantation, 3 at a later time, and 3 not replaced.

Conclusions:  Most reports cite reoperation frequencies in the range of 20%-25%, but these studies often extend back to the 1980s or early 1990s and include patients who undergo multiple surgeries, often for capsular contracture or replacement of silicone gel implants. We are following only primary augmentation patients who began receiving saline implants in 1997, when the number of women requesting this procedure started to rise dramatically. Our data reflect the use of modern devices and techniques. Thus far, we have found a low frequency of complications and reoperations, with a total of 10% of patients and 6.5% of breasts requiring revision. Additional patient and follow-up data will be accumulated in future years.

Table 1. Patients with and without Reoperations

	Total	No Revisions	Reoperations
Number of primary augment patients	287	258	29 (10.1%)
Number of breasts	573	536	37 (6.5%)
Number of implants	593	536	55 (9.3%)
Mean patient age at augment (range)	32.8 yr	32.8 yr (17-54)	32.2 yr (19-50)
Mean implant follow-up (range)	8.6 mo	8.3 mo (0-55.8)	11.0 mo (0-34.3)
Mean age of explanted implants			10.2 mo (0-30.5)