Adverse Events in Women with Silicone Gel Breast Implants: A Systematic Review

Project Summary Title and Description

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. PMID 10739783 Full report available at Data entered into SRDR prospectively.
Funding Source
The Plastic Surgery Foundation

Key Questions

1. What are the harms associated with silicone gel breast implants in women?

Associated Extraction Forms

Associated Studies (each link opens a new tab)

Long-term health status of Danish women with silicone breast implants.2004
Births and perinatal health of infants among women who have had silicone breast implantation in Finland, 1967-2000.2004
Rupture of silicone gel breast implants and symptoms of pain and fatigue.2003
Silicone breast prostheses and rheumatic symptoms: a retrospective follow up study.1994
A comparison of outcomes involving highly cohesive, form-stable breast implants from two manufacturers in patients undergoing primary breast augmentation.2010
Carcinogenic potential of silicone breast implants: a Connecticut statewide study.1997
Breast enlargement and reduction: results from a breast cancer case-control study.1996
Copious lactation following augmentation mammaplasty: an uncommon but not rare condition.1994
Does long-term exposure to gel-filled silicone implants increase the risk of relapse after breast cancer?1998
Lactation after augmentation mammoplasty.1996
Connective-tissue disease following breast augmentation: a preliminary test of the human adjuvant disease hypothesis.1988
Breast cancer diagnosis in women with subglandular silicone gel-filled augmentation implants.1995
Cancer risk among Los Angeles women with cosmetic breast implants.2007
Mentor Contour Profile Gel implants: clinical outcomes at 6 years.2012
A clinical study of the relationship between silicone breast implants and connective tissue disease.1998
Breast implants and breast cancer--reanalysis of a linkage study.1995
Incidence of autoimmune disease in patients after breast reconstruction with silicone gel implants versus autogenous tissue: a preliminary report.1993
Augmentation mammoplasty: results of a patient survey.1993
Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants.2009
Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation.2006
Comparative examination of complaints of patients with breast-cancer with and without silicone implants2002
Women's health after plastic surgery.2001
Health risks of failed silicone gel breast implants: a 30-year clinical experience.1994
First evaluation study of the Dutch Working Party on silicone breast implants (SBI) and the silicone-related symptom complex (SRSC).2000
A prospective study on silicone breast implants and the silicone-related symptom complex.2002
The health status of women following cosmetic surgery.1994
The Mentor Core Study on Silicone MemoryGel Breast Implants2007
The epidemiology of scleroderma among women: assessment of risk from exposure to silicone and silica.1996
Potential risk factors for undifferentiated connective tissue disease among women: implanted medical devices.2001
Prospective cohort study of breast implants and the risk of connective-tissue diseases.2011
The use of silicone breast prosthesis in Puerto Rico.1992
Aesthetic mammary augmentation with silicone prostheses. A five years retrospective analysis [Spanish]1994
Autoimmune connective tissues and mammary prosthesis: Controlled study on our patients who underwent post-mastectomy breast reconstruction [Italian]1993
Health characteristics of postmenopausal women with breast implants.2010
Connective tissue disease and other rheumatic conditions following breast implants in Denmark.1997
Cancer among Scandinavian women with cosmetic breast implants: a pooled long-term follow-up study.2009
Breast implants following mastectomy in women with early-stage breast cancer: prevalence and impact on survival.2005
Neurological disease among women with silicone breast implants in Denmark.2001
Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants.2003
Characteristics of women with cosmetic breast implants compared with women with other types of cosmetic surgery and population-based controls in Denmark.2003
Silicone breast implants and the risk of connective-tissue diseases and symptoms1995
Cancer incidence in a cohort of Ontario and Quebec women having bilateral breast augmentation.2006
Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women.2001
The prevalence of systemic autoimmune diseases in women reconstructed with silicone breast implants after mastectomy. A comparative study1998
Risk of connective-tissue diseases and other disorders after breast implantation.1994
Breast cancer following augmentation mammoplasty (United States).2000
Summary of Safety and Effectiveness Data: Inamed Silicone-Filled Breast Implants. PMA P020056.2006
Summary of Safety and Effectiveness Data: Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants. PMA P0400462013
Summary of Safety and Effectiveness Data: Mentor MemoryGel™ Silicone Gel-Filled Breast Implants. PMA P0300532005
Summary of Safety and Effectiveness Data (SSED): MemoryShape™ Breast Implants. PMA P0600282013
Risk of connective tissue disease and related disorders among women with breast implants: a nation-wide retrospective cohort study in Sweden.1998
Summary of Safety and Effectiveness Data (SSED): Sientra Silicone Gel Breast Implants. PMA P0700042012
Silicone gel-filled breast implants and connective tissue diseases.1998
Survey of breast implant patients: characteristics, depression rate, and quality of life.2013
Evaluation of the psychological benefits of breast augmentation for aesthetic purposes. Results of a multicenter prospective study of a series of 181 patients.2013

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