ISSN Online: 2177-1235 | ISSN Print: 1983-5175
Previous results and complication rates indicate that the use of textured silicone implants filled with silicone gel for breast augmentation in hypomastia or breast reconstruction is safe and predictable.
However, recently, there has been concern about the use of breast implants filled with silicone gels that are not approved for medical use. Using these implants would imply going against medical ethics, which is the responsibility of the professional who performs the surgery.
In numerous editorials, we have insisted on the application of evidence-based medicine in plastic surgery - that is, the use of the most modern resources medicine has at its disposal supported by clinical evidence in order to offer the best possible treatment to our patients.
Surveys assessing quality of life are critical instruments for determining the scientific validity of therapeutic performance in plastic surgery. The interpretation of the results obtained with this approach can be considered a rational tool for making decisions related to patient care.
The positive impacts of the placement of breast implants, especially in mammaplasty augmentation, on the quality of life of patients are understood by taking into consideration the risks and limitations1-6.
Then how do we determine the impact of the current problem on the quality of life of patients who have or have not received these problematic implants? It is likely that the quality of life of patients receiving these problematic breast implants is compromised, even though the majority will never experience problems.
The totally subjective perception of the potential risk of complications is enough to impact the assessment of quality of life. Accordingly, what should we say regarding possible changes in quality of life due to necessary, but not previously planned surgical procedures, for exchanging the implants, its risks, and cost?
Developing validated instruments for evaluating performance, including surveys on quality of life, is a complex and slow process that undergoes constant changes dependent on social, cultural, and economic conditions. In general, since these changes exhibit a certain degree of predictability, we can include them in the scientific methodology used. However, the appearance of unexpected problems or problems not included in these evaluation methods might invalidate such surveys, thus invalidating all previous work.
It took decades of longitudinal studies to establish the safe usage of textured implants filled with silicone gel. While the recent issues do not invalidate the previously confirmed certainties, they put into question the effectiveness of previously established evaluation methods. We may have to revise these evaluation methods or come to a stage that could necessitate a few more decades to investigate the impacts of these issues on the quality of life of affected patients.
Dov Charles Goldenberg
1. Jewell ML, Jewell JL. A comparison of outcomes involving highly cohesive, form-stable breast implants from two manufacturers in patients undergoing primary breast augmentation. Aesthet Surg J. 2010;30(1):51-65.
2. Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the Breast-Q. Plast Reconstr Surg. 2009;124(2):345-53.
3. Rohrich RJ, Rathakrishnan R, Robinson Jr JB, Griffin JR. Factors predictive of quality of life after silicone-implant explanation. Plast Reconstr Surg. 1999;104(5):1334-7.
4. Crerand CE, Infield AL, Sarwer DB. Psychological considerations in cosmetic breast augmentation. Plast Surg Nurs. 2009;29(1):49-57.
5. Murphy DK, Beckstrand M, Sarwer DB. A prospective, multi-center study of psychosocial outcomes after augmentation with Natrelle silicone-filled breast implants. Ann Plast Surg. 2009;62(2):118-21.
6. Pusic AL, Reavey PL, Klassen AF, Scott A, McCarthy C, Cano SJ. Measuring patient outcomes in breast augmentation: introducing the Breast-Q Augmentation module. Clin Plast Surg. 2009;36(1):23-32.
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