- Adverse Events in Women with Silicone Gel Breast Implants: A Systematic Review
- Breast implants are medical devices used to reconstruct the breast following mastectomy, to augment breast size, or to correct a congenital abnormality.1 Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). In the US about half of implants are silicone gel-filled implants. Recently, the Food and Drug Administration (FDA) has recommended the creation of a surveillance registry to monitor for potential adverse events associated with silicone gel breast implants. However, a clinical registry that can provide meaningful data on the long-term safety requires a large number of patients and rigorous patient follow-up, both of which have been difficult for breast implant companies to achieve. The American Society of Plastic Surgeons (ASPS®) and the Plastic Surgery Foundation (PSF) has solicited this systematic review (SR) to summarize the state of the literature on safety outcomes in women with silicone gel breast implants for the purpose of informing the development of the registry.
- Authors of Report
- Methodology description
- Comprehensive literature searches were conducted in MEDLINE, EMBASE, and Ovid Healthstar (inception through 30 June 2015), as well as the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews (through the first quarter of 2015). Additional citations were solicited from the Advisory Panel. The searches combined terms for silicone gel implants and outcomes of interest. Four researchers screened citations in duplicate, and discrepancies were resolved in a group conference. Reference lists of existing systematic reviews, selected narrative reviews, and included studies were screened. Retrieved full-text articles were rescreened in duplicate.
We included studies of any longitudinal design comparing women with and those without breast implants. Studies included women with any history of silicone gel-filled breast implants, excluding injected silicone, silicone tissue expanders, and recalled implants produced by Poly Implant Prothèse (La Seyne-sur-Mer, France). At least one half the participants had to have silicone gel (vs. saline) implants, but to avoid inadvertently excluding eligible studies, we included studies that did not report the proportion of participants with silicone gel implants. Comparison groups included either women with no implants (including the general population), women with saline breast implants, or women undergoing other cosmetic surgery procedures. We excluded studies of only women with specific signs or symptoms (e.g., only women with joint pain) or only women seen in a specialty clinic (e.g., women evaluated by a rheumatologist), who do not represent the general population.
Study Extraction and Assessment
Data from each study were extracted by 1 of 4 methodologists and confirmed by at least 1 other experienced methodologist. Extracted data included study, participant, and implant characteristics, including use for reconstruction or augmentation; study country; implantation dates and duration; outcomes; analytical methods; and results. We preferentially extracted the most adjusted models comparing implants with no implants, and we captured all factors that were adjusted for. We extracted both direct comparisons of implants versus no implants and indirect comparisons, such as standardized incidence ratios (SIRs).
To assess study quality, we applied an adaptation of the McMaster Quality Assessment Scale of Harms (McHarm) Tool. We also applied selected quality questions from the Newcastle-Ottawa Scale for quality assessment of observational and case–control studies.
- Published as:
Ann Intern Med. 2015 Nov 10:1-12. doi: 10.7326/M15-1169. [Epub ahead of print]
Long-Term Health Outcomes in Women with Silicone Gel Breast Implants: A Systematic Review.
Balk EM, Earley A, Avendano EA, Raman G.
Full report available at http://www.brown.edu/academics/public-health/research/evidence-based-medicine/research-initiatives/technical-reports
Data entered into SRDR prospectively.
- Funding Source
- The Plastic Surgery Foundation