Economic Analysis of Screening Strategies for Rupture of Silicone Gel Breast Implants

Section of Plastic Surgery, The University of Michigan Medical School, Ann Arbor, Mich 48109-0340, USA.
Plastic and Reconstructive Surgery (Impact Factor: 2.99). 07/2012; 130(1):225-37. DOI: 10.1097/PRS.0b013e318254b43b
Source: PubMed


In 2006, the U.S. Food and Drug Administration recommended screening of all women with silicone gel breast implants with magnetic resonance imaging 3 years after implantation and every 2 years thereafter to assess their integrity. The cost for these serial examinations over the lifetime of the breast implants is an added burden to insurance payers and to women. The authors performed an economic analysis to determine optimal screening strategies by considering the diagnostic accuracy of the screening tests, costs of the tests, and subsequent implant removal.
The authors determined aggregate/pooled values for sensitivity and specificity of the screening tests of ultrasound and magnetic resonance imaging in detecting silicone breast implant ruptures from the data obtained from published literature. They compiled costs, based on Medicare reimbursements for 2011, for the following elements: imaging modalities, anesthesia, and three surgical treatment options for detected ruptures. A decision tree was used to compare three alternate screening strategies of ultrasound only, magnetic resonance imaging only, and ultrasound followed by magnetic resonance in asymptomatic and symptomatic women.
The cost per rupture of screening and management of rupture with ultrasound in asymptomatic women was $1090; in symptomatic women, it was $1622. A similar cost for magnetic resonance imaging in asymptomatic women was $2067; in symptomatic women it was $2143. A similar cost for ultrasound followed by imaging in asymptomatic women was $637; in symptomatic women, it was $2908.
Screening with ultrasound followed by magnetic resonance imaging was optimal for asymptomatic women, and screening with ultrasound was optimal for symptomatic women.

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    • "Therefore, MRI has evolved over the last 10 years to become the number one imaging tool for identification of both intracapsular and extracapsular implant rupture. Mammography and computed tomography have been abandoned due to specific drawbacks, including the risk of implant damage and radiation exposure.2 Ultrasound imaging may be the way of the future. "
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    ABSTRACT: Background Silicone gel breast implants may silently rupture without detection. This has been the main reason for magnetic resonance imaging (MRI) of the augmented or reconstructed breast. The aim of the present study was to investigate the accuracy of MRI for implant rupture. Methods Fifty consecutive patients with 85 silicone gel implants were included in the study. The mean age of the patients was 51 (range 21–72) years, with a mean duration of implantation of 3.8 (range 1–28) years. All patients underwent clinical examination and breast MRI. Intraoperative implant rupture was diagnosed by the operating surgeon. Results Nineteen of the 50 patients suffered from clinical symptoms. An implant rupture was diagnosed by MRI in 22 of 85 implants (26%). In seven of 17 removed implants (41%), the intraoperative diagnosis corresponded with the positive MRI result. However, only 57% of these patients were symptomatic. Ultrasound imaging of the harvested implants showed signs of interrupted inner layers of the implant despite integrity of the outer shell. By microsurgical separation of the different layers of the implant shell, we were able to reproduce this phenomenon and to produce signs of implant rupture on MRI. Conclusion Our results show that rupture of only the inner layers of the implant shell with integrity of the outer shell leads to a misdiagnosis on MRI. Correlation with clinical symptoms and the specific wishes of the patient should guide the indication for implant removal.
    International Journal of Women's Health 07/2014; 6:703-709. DOI:10.2147/IJWH.S58493
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    ABSTRACT: Oncologic, reconstructive, and cosmetic breast surgery has evolved in the last 20 years. Familiarity with cutting-edge surgical techniques and their imaging characteristics is essential for radiologic interpretation and may help avert false-positive imaging findings. Novel surgical techniques include skin- and nipple-sparing mastectomies, autologous free flaps, autologous fat grafting, and nipple-areola-complex breast reconstruction. These techniques are illustrated and compared with conventional surgical techniques, including modified radical mastectomy and autologous pedicled flaps. The role of magnetic resonance (MR) imaging in surgical planning, evaluation for complications, and postsurgical cancer detection is described. Breast reconstruction and augmentation using silicone gel-filled implants is discussed in light of the Food and Drug Administration's recommendation for MR imaging screening for "silent" implant rupture 3 years after implantation and every 2 years thereafter. Recent developments in skin incision techniques for reduction mammoplasty are presented. The effects of postsurgical changes on the detection of breast cancer are discussed by type of surgery. ©RSNA, 2014.
    Radiographics 05/2014; 34(3):642-60. DOI:10.1148/rg.343135059 · 2.60 Impact Factor
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    ABSTRACT: Silicone breast implants are commonly used in breast surgery, either for esthetic or reconstructive procedures. There have been several case reports of silicone migration, with or without implant rupture. One of the possible consequences of such migration is the formation of siliconomas.We performed an exhaustive review of the literature, which is relatively scarce and disperse, on the diagnosis, treatment, and possible complications of this entity and its differential diagnosis with breast cancer and axillary metastasis. This article also discusses the latest available information and recommendations on Poly Implant Prostheses. Due to their characteristics, these implants show a high frequency of rupture, silicone migration, siliconomas, and related complications.The rate of silicoma formation is unknown but is strongly associated with implant rupture and subsequent gel migration. The breast implants of choice are those made of highly cohesive silicone gel. The most important problem associated with siliconomas is the differential diagnosis with breast cancer and axillary metastasis, in which magnetic resonance is the gold standard diagnostic technique.Once a silicoma has been diagnosed, the most suitable option is its surgical removal and implant replacement.
    04/2013; 26(2):58–64. DOI:10.1016/j.senol.2013.01.002
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