Purpose:  To determine if large-volume breast implants are associated with an increased frequency of complications or decreased patient satisfaction following primary augmentation mammoplasty.

Methods:  Between Jan. 1, 1997 and Dec. 31, 2001, 276 consecutive primary augmentation patients (552 breasts) received saline implants with a variety of fill volumes. These patients are being prospectively followed to collect data on a variety of variables related to the patients, breasts, and implants. As part of the study, all local complications, reoperations, and explantations are tracked to determine their frequency and possible causes. The subset of data presented describes the relationship between complications and implant size.

Results:  Of the 276 primary augmentation patients, 31 (11%) had 35 revisional procedures on 47 breasts. Eighteen breasts had a revision with no implant exchange, 23 received a new implant, and 4 breasts underwent explantation only, with 2 being re-augmented at a later time. A total of 575 saline implants were implanted. Their fill volumes ranged from 225 cc to 775 cc, with a mean volume of 445 cc. The reoperation frequency for implants filled with <350 cc was nearly twice as high as for implants filled with ≥600 cc (18.3% vs. 9.5%, respectively). However, the average follow-up time for smaller implants is nearly 6 months longer than for larger implants. For the group as a whole, the average time between primary surgery and a revision is 13.4 months (range=0–66).

Table 1 shows major variables related to implant fill volume, including the numbers and percentages of revision surgeries according to different volume ranges. The volume groupings represent the distribution of data around the study population mean of 445 cc. Patients who received larger-size implants had a slightly higher Body Mass Index (BMI) prior to augmentation, as well as slightly larger preop bra size (both bra band and cup size). Satisfaction with implants (rated by patients on a 5-point scale) is consistently high across all volume groups. Reasons for revision are generally consistent across all volume groups, and only 25% of reoperations (12 of 47) were required for true complications. Except for 1 hematoma and 1 deep infection, all revisions of breasts with 500+ volumes were done for cosmetic reasons at patient request. The 3 deflations, 4 implant migrations, 1 severe capsular contracture, and 2 other hematomas occurred with volumes £475 cc. The most frequent complication was grade III implant palpability, which did not lead to reoperation. The distribution of palpability by volume and implant surface is also shown in Table 1.

Conclusions:  Some surgeons strongly oppose the use of breast implants larger than 350-400 cc. In our practice, however, patients want larger sizes, and this desire has been accommodated during the last few years because no data showed they were contraindicated. This prospective study is the first to investigate the volume issue in a systematic way and  indicates that larger-volume implants do not seem to cause more complications or reoperations than smaller-volume implants.

Table 1. Revisions and Complications by Implant Volume

	200-349 cc	350-399 cc	400-499 cc	500-599 cc	600-775 cc	Total Group
# Breasts	60	97	255	119	42	573
# Breasts Revised	11	6	16	10	4	47
% Breasts Revised	18.3	6.2	6.3	8.4	9.5	8.2
Avg FU mo (range)	14.5 (0.5-66)	15.1 (0.3-66)	13.6 (0.5-74)	9.8 (0.3-40)	8.8 (0.5-34)	12.6
Avg BMI	20.1	19.8	19.9	20.5	20.8	20.0
Avg Satisfaction	4.5	4.7	4.6	4.3	4.6	4.6
Grade 3 palpability						55
Smooth	4	6	14	3	0
Textured	2	16	10	0	0