Magnetic Resonance Imaging and Explantation Investigation of Long-Term Silicone Gel Implant Integrity

Abstract

Although these results cannot necessarily be extrapolated to other implant types and manufacturers, they provide further information about the natural history of implant integrity, better enabling us to counsel prospective and current implant recipients.

The Effect of Study Design Biases on the Diagnostic Accuracy of Magnetic Resonance Imaging for Detecting Silicone Breast Implant Ruptures: A Meta-Analysis

“…Reasons for further exclusion are described in Figure 3. Eight studies examined both ultrasound and MRI,29–36 5 evaluated US only,37–41 and 8 evaluated MRI only 42–49…”

“…All 21 studies were diagnostic cohort studies 29–36, 42–49 Table 3. summarizes characteristics of the included studies.…”

“…More than 50% of the 16 MRI studies used a sample that was not representative of a screening sample (10 studies examined only symptomatic patients29–31, 33, 34, 36, 44, 45, 47, 48, 2 studies examined only asymptomatic patients35, 42), 9 did not explain reasons for individuals withdrawing from the study29–32, 36, 42, 44–46, and 11 did not report uninterpretable results 29, 30, 32–34, 43–46, 48, 49. The reference test diagnostic criteria were not specified in 7 studies (43.8%)29, 34, 35, 42–44, 48, and 7 studies (43.8%)31, 34, 42–44, 48, 49 had partial verification bias (Figure 4A-B). More than 50% of the 13 ultrasound studies did not use a screening sample (10 studies examined only symptomatic patients29–31, 33, 34, 36–39, 41, 1 study examined only asymptomatic patients35), and 11 did not explain reasons for individuals withdrawing from the study29–33, 36–41(Figure 5A-B).…”

“…This information is important especially for screening tests, given the possibility that rupture may have occurred during the interim period before explantation; this context is also known as disease progression bias. In addition, a few MRI (3 of 16)33, 42, 47 and ultrasound (2 of 13)33, 36 studies discussed the possibility of rupture at the time of explantation, an important detail given a surgical reference test.…”

Diagnosing PIP breast implant failure: A prospective analysis of clinical and ultrasound accuracy

“…10,31 Studies have shown variation in operators to range for sensitivity from 71% to 86%, and for specificity from 48% to 95%. 32 Despite these small studies, ultrasound is still recommended as a highly effective tool in varying hands, provided a careful methodological approach is followed, and knowledge of pitfalls is considered. 33 Based on our findings we would recommend that PIP implant explantation should not be offered solely on the basis of patient history and clinical impression, as is currently recommended.…”