Women who underwent breast augmentation reported improved self-esteem, self-image and highly satisfactory results with the shape, size and feel of their silicone gel implants.21,22
Therefore any unwarranted explantation can result in disfigurement and a huge emotional setback for these women. Additionally, the cost incurred in exploring a false positive case is too high. The national average for surgeon/physician fee in 2010 for breast augmentation was $3,351 (total $992,432,214) and that for removal was $2,288 (total $49, 689,719).1
For highly emotional and resource intensive concern such as silicone breast implants, economic analysis is an effective means to arrive at screening algorithms that impose minimal burden possible on the patient and society, yet yielding accurate results.
The 2006 FDA recommendation to evaluate all silicone breast implants with successive MRI to identify silent ruptures3,23
has raised much controversy in the healthcare community. In our current culture of healthcare cost constraint, it is difficult to justify the use of expensive MRI testing when the consequences of asymptomatic rupture have been shown to be minimal.24
Furthermore, paucity of precise data with regards to MRI accuracy19
and the lack of demonstrable benefit of screening in asymptomatic women may dissuade patients from following the FDA's recommendation. The costs of MRI screening over the lifetime of the average woman, which may not be covered by the patients' insurance, may exceed the costs of initial surgery.23,25
However, if more affordable screening strategy can be supported by scientific data, then more patients and plastic surgeons may be encouraged to participate in these screening efforts to define the true risk of ruptures and health consequences for the silicone gel implants that have garnered resurgent interests in the US and abroad.
Our study shows that screening asymptomatic women with US, followed by MRI screening in US positive patients is the least expensive strategy to detect silent rupture ($637/ rupture detected and managed) . Too low prevalence of rupture (8%) in asymptomatic women results in high false positives with US, therefore screening the US positive women with MRI to confirm the rupture is a good approach in order to prevent the unnecessary exploration of intact implants, and to minimize costs and stress to the women. For screening symptomatic women, our study shows that US alone ($1,622/rupture detected and managed) is the optimal strategy. With the extra-capsular rupture, women tend to present with symptoms such as capsular contracture and breast asymmetry, unlike an intracapsular rupture that is clinically silent and the women's breasts feel normal. Therefore, screening symptomatic women with US alone is ideal because US detects extra-capsular ruptures very well.
As per FDA recommendations, in asymptomatic women, with a cost of $2,067 per rupture detected and managed with MRI, the total cost of detecting and managing all the ruptures that occurred in 2010 alone will be 3 times greater when compared to the total cost incurred with US followed by MRI, (total costs $33,135,828 vs. $8,748,558) as suggested by our study. Similarly, in symptomatic women, with a cost of $2,143 per rupture detected and managed with MRI, the total cost of detecting and managing all the ruptures that occurred in 2010 alone for example, will be 1.3 times greater when compared to the total cost incurred with US alone (total costs $141,706,875 vs. $107,254,750) with a cost of $1,622 per rupture detected and managed. These numbers were obtained taking into account augmentations and reconstructions performed in only 2010, the difference will be even greater when considering total number of women with implants into account. These additional costs will be a huge burden on women with implants and also society as most of the women with silicone implants are younger and therefore not covered by Medicare.
This study has several limitations. Ideally, data for the economic analysis should be obtained from randomized clinical trials, but because none have been conducted so far to detect implant ruptures, we derived data form published literature with silicone gel implants of varying brands. Some of the published studies lack the specific mention whether the study sample comprised of symptomatic or asymptomatic women, because of this concern these studies were excluded. Furthermore, majority of the studies were done in symptomatic women. We found only two studies with MRI and only one study with US done exclusively in asymptomatic women which limits the analysis. Our costs did not include societal costs such as loss of work, which is extremely difficult to capture because variability in job descriptions. Typically, breast implant removal or insertion is done as an outpatient procedure with patient being discharged on the same day from the hospital. Cost of breast implants was not included as the CPT code because cost of implants was not available from the Medicare RBRVS. But including the cost of the implants will not change the comparative analysis of these various screening strategies. In addition, in the decision trees for US followed by MRI, we assumed the sensitivity and specificity of MRI to be same as that for doing MRI alone. Sensitivity and specificity of MRI performed after US (either positive or negative US test) may be different from those performing MRI alone, as the sample population will be different.
The FDA recommends performing serial MRIs to ascertain the implant integrity because of its higher sensitivity and specificity reported in studies. However, a meta-analysis study by Song and Chung et al. revealed that there are several biases in the studies reporting higher accuracy of MRI.19
The diagnostic odds ratio, a measure for overall diagnostic test performance of MRI was found to be 14 times greater in symptomatic samples than asymptomatic samples and the pooled estimate of sensitivity and specificity were 87% and 89.9% respectively. Cher et al. concluded from a meta-analysis study that the positive predictive value (PPV), the probability of having the rupture among those who are tested positive, of MRI was good (>80%) when the prevalence of rupture was high (50%) but the PPV never exceeded 80% when the prevalence of rupture was low (10%). Summary estimates of sensitivity and specificity in that study were 78% (95% CI: 71–83) and 91% (95% CI: 86–94) respectively.20
This meta-analysis included studies in symptomatic women, thus the authors suggested limiting the use of MRI to confirm ruptures in clinically suspected women.