Study Provides Data on 'Patient-Reported Outcomes' for Different Types of Silicone Implants

Arlington Heights, Ill. - For women undergoing breast reconstruction using implants, most patient-reported outcomes are similar with two different shapes of silicone gel-filled implants, reports a study in the March issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).

Assessment of key areas of quality of life after breast reconstruction shows few significant differences with conventional round implants versus newer "shaped" implants, according to the new research, led by Dr. Sheina A. Macadam of University of British Columbia, Vancouver.

Does Implant Shape Affect Breast Reconstruction Outcomes?
The researchers evaluated patient-reported outcomes in women who underwent breast reconstruction with implants after mastectomy for breast cancer. Reconstructions were done using two different types of silicone gel-filled implants: conventional round implants and anatomical "shaped" implants. The study included 65 women receiving round implants and 63 receiving 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, including satisfaction with breasts and with overall outcome, psychosocial, sexual, and physical well-being, and satisfaction with care. Quality of life is increasingly regarded as an important factor in evaluating the benefits of various types of medical or surgical treatments.

Data on patient-reported outcomes was collected one to four years after breast reconstruction. About 80 percent 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. Just one area differed significantly between groups: women with shaped implants rated their breasts as firmer than women with round implants.

Findings May Help to Guide Women's Choice of 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," Dr. Macadam and colleagues write.

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.

Dr. 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.

Plastic and Reconstructive Surgery® is published by Lippincott Williams & Wilkins, part of Wolters Kluwer Health.

About ASPS

The American Society of Plastic Surgeons (ASPS) is the world's largest organization of board-certified plastic surgeons. Representing more than 7,000 Member Surgeons, the Society is recognized as a leading authority and information source on aesthetic and reconstructive plastic surgery. ASPS comprises more than 94 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the Society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada. ASPS advances quality care to plastic surgery patients by encouraging high standards of training, ethics, physician practice and research in plastic surgery. 

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