For women undergoing breast reconstruction using implants, most patient-reported outcomes are similar with two different shapes of silicone gel-filled implants. Assessment of key areas of quality of life after breast reconstruction found few significant differences with conventional round implants versus newer “shaped” implants, according to the new research.
The investigators sought to understand if implant shape affected breast reconstruction outcomes. They evaluated patient-reported outcomes in women who underwent breast reconstruction with implants after mastectomy for breast cancer. Reconstructions were done using the two different types of silicone gel-filled implants. The study included 65 women who received round implants and 63 who received shaped implants. The round implants all had a smooth surface, while the shaped implants had a textured surface.
The patients completed the BREAST-Q questionnaire, which evaluated changes in several areas of health-related quality of life: satisfaction with breasts and with overall outcome; psychosocial, sexual, and physical well-being; and satisfaction with care. Quality of life is increasingly regarded as important in evaluating the benefits of various types of medical or surgical treatments.
Data on patient-reported outcomes was collected 1 to 4 years after breast reconstruction. About 80% of women in both groups had reconstruction immediately after mastectomy.
The BREAST-Q data showed good overall outcomes with both types of implants. Average scores for satisfaction with the overall reconstruction (on a 100-point scale) were approximately 77 for women receiving shaped implants and 75 for those with round implants. Scores for satisfaction with the breasts were about 64 in both groups.
Scores in other areas—including psychological and sexual well-being—were also similar for the two groups. The only significant difference between the groups was that women with shaped implants rated their breasts as firmer than women with round implants.
In a finding important to plastic surgeons, there was no difference in implant “rippling” between groups. Rippling, or wrinkling, had been a drawback of the first generation of shaped implants. Newer shaped silicone implants are not yet approved in the United States; clinical trials are underway.
New implants are introduced to the breast reconstruction market with limited data on the outcomes important to patients—especially in terms of how the reconstruction affects key areas of quality of life. “Patient-reported outcomes data is required to provide guidance based on previous patients’ experience and satisfaction profiles,” wrote lead author Sheina A. Macadam, MD, MHS, of the University of British Columbia in Vancouver and colleagues.
The new study finds few differences in patient-reported outcomes after breast reconstruction with round versus shaped implants. “[T]hese two types of silicone implants are equivalent in terms of satisfaction with outcome,” according to the authors.
Macadam and colleagues point out the increased firmness of shaped implants as “the one notable difference” between the two types. They believe their findings will help surgeons inform patients about the expected outcomes of reconstruction using round versus shaped implants, and may help to guide introduction of the shaped implants for widespread use. This study was reported in Plastic and Reconstructive Surgery (2013;131:431-441).