Magnetic Resonance Imaging Screening after Silicone Implant… : Plastic and Reconstructive Surgery

Since their introduction in the 1960s, silicone breast implants have been increasingly used.1 Complications associated with any implant include capsular contracture, infection, asymmetry, malposition, and rupture. Implant rupture is one of the leading reasons for implant removal, and silicone leakage is of particular concern because of potential adverse systemic consequences.2 The frequency of rupture has been reported to be as high as 30 percent at 5 years, 50 percent at 10 years, and 70 percent at 17 years.3 Although patients with implant rupture may present with breast asymmetry, pain, or nodule formation, some cases are asymptomatic.4 In some studies, physical examination failed to detect implant rupture in over half the cases.3,4 Since 2006, the U.S. Food and Drug Administration has recommended that patients with silicone breast implants undergo routine magnetic resonance imaging for detection of implant rupture beginning 3 years after implantation and every 2 years thereafter.5 Based on previous clinical encounters, we hypothesized that patients do not adhere to this recommendation for various reasons, including the indication for their breast surgery or insurance coverage. The purpose of this study was to determine the proportion of a rural population of patients who had undergone silicone implant placement and were aware of and adherent to the U.S. Food and Drug Administration’s magnetic resonance imaging screening recommendation. A secondary objective was to identify potential barriers to magnetic resonance imaging screening.


Institutional review board approval was obtained. Using relevant CPT codes, we searched the electronic medical record for patients older than 18 years who underwent silicone breast implant placement between 2011 and 2016. The U.S. Food and Drug Administration recommendation was typically discussed with patients during perioperative visits and reinforced by informational pamphlets. Patients who had died were excluded, as were those with implants in place fewer than 3 years at the time of survey, as these implants were not in place long enough to require screening, according to the recommendation. After verbal consent was given, patients meeting inclusion criteria were surveyed by telephone using a standardized script to assess awareness of the recommendations, whether they had undergone magnetic resonance imaging screening, and barriers to testing. (See Appendix, Supplemental Digital Content 1, which shows the telephone script used to survey participants, https://links.lww.com/PRS/F188.) Patients who declined to participate or who could not be contacted were excluded. The electronic medical record was reviewed for relevant demographics, insurance information, and operative data, and to clarify survey responses. Median household income was estimated using data from the U.S. Census Bureau, based on county and state of residence.6

Our hypothesis was that patients do not adhere with this recommendation for various reasons. To address this, we assessed overall rates of magnetic resonance imaging and adherence with the U.S. Food and Drug Administration recommendation. To err on the side of adherence, breast magnetic resonance imaging examinations performed for any reason within the recommended timeframe were considered adherent to the recommendation. For each population proportion reported, one-sample 95 percent confidence intervals were calculated when assumptions of normality were satisfied; when these conditions were not satisfied, an exact binomial confidence interval was determined. Fisher exact tests of independence were conducted to identify additional factors associated with magnetic resonance imaging adherence. Bias-reduced logistic regression models were conducted to control for potential confounding between income, procedure performed, whether the patient had any insurance, and age as they pertain to adherence to the U.S. Food and Drug Administration regulation.7 The fit for the logistic regression model was assessed using the concordance statistic (C statistic). Odds ratios were reported for univariable and multivariable associations between magnetic resonance imaging adherence and implant type, median household income per county, availability of health insurance coverage, and insurance type. Statistical analyses were performed using R statistical software with significance accepted at an alpha level of 0.05.


Of 370 patients meeting inclusion criteria, 130 were able to be contacted. Verbal consent to participate was obtained from 109 patients (84 percent; 95 percent CI, 77.7 to 90.3 percent) (mean age, 51 years at the time of surgery and 56 years when surveyed). A summary of general study characteristics is listed in Table 1. Eighty-six patients underwent breast reconstruction and 23 underwent breast augmentation. Seventeen patients (15.6 percent; 95 percent CI, 9.4 to 23.8 percent) had undergone magnetic resonance imaging at any time after implant placement, although only six of these patients underwent magnetic resonance imaging within the timeframe recommended by the U.S. Food and Drug Administration (5.9 percent; 95 percent CI, 0.15 to 28.7 percent). Among the 17 patients who underwent magnetic resonance imaging, 11 (73.3 percent; 95 percent CI, 50.9 to 95.7 percent) also underwent ultrasound or mammography before and/or after the magnetic resonance imaging. Among all respondents (n = 109), 53 (48.6 percent; 95 percent CI, 38.9 to 58.4 percent) underwent ultrasound or mammography for various reasons (e.g., cellulitis, cancer surveillance, pain) after implant placement. Logistic regression analysis (C statistic, 75.8 percent; 95 percent CI, 58.2 to 93.5 percent) found no difference in magnetic resonance imaging adherence between patients with implants inserted for cosmetic or reconstructive indications (OR, 0.74; 95 percent CI, 0.01 to 7.10; p = 1.00) and no difference between textured and smooth implants (OR, 2.82; 95 percent CI, 0.24 to 21.9; p = 0.24), after excluding two patients with missing data. Availability of health insurance was not associated with greater magnetic resonance imaging adherence (p = 0.58), nor was residing in a county with a median annual household income above the median for the state (p = 0.33). Results of the univariable analyses and multivariable logistic regression analyses are summarized in Tables 2 through 4. (See Figure, Supplemental Digital Content 2, which shows area under the curve analysis, https://links.lww.com/PRS/F189.)

Table 1. -
Frequency of Demographics, Implant Type, Surgery Type, Economic Factors, and Magnetic Resonance Imaging Surveillance

Characteristic Value (%)*
Mean age at the time of surgery ± SD, yr 51 ± 11.43
Surgery type
 Reconstruction 86 (78.9)
 Cosmetic augmentation 23 (21.1)
Implant surface type
 Textured 17 (15.9)
 Smooth 90 (84.1)
Insurance type
 None 17 (15.6)
 Medicare/Medicaid 33 (30.3)
 BCBS 29 (26.6)
 Cigna 10 (9.2)
 Other 20 (18.3)
County median household income > state median household income 27 (24.8)
MRI performed within FDA recommendation 6 (5.9)
MRI performed at all since surgery 17 (15.6)
Other imaging performed since surgery 53 (48.6)
 Mammography 34 (31.2)
 Ultrasound 19 (17.4)

BCBS, Blue Cross Blue Shield; MRI, magnetic resonance imaging; FDA, U.S. Food and Drug Administration.

*Among the 109 survey respondents. Implant surface type not documented in the electronic medical record for two patients.

Other insurance including through Veterans Association, Primex, United Healthcare, Health Plans Incorporated, Martins Point, Harvard Pilgrim, Tufts Health, MVP, and Beacon Health.

Table 2. -
Univariable Analysis of Surgery Type, Implant Type, Presence of Insurance, and Median Household Income and Adherence to U.S. Food and Drug Administration Recommendation

Characteristic OR 95% CI
Age at the time of surgery 1.00 0.99–1.00 0.62
Cosmetic augmentation (vs. reconstruction) 0.74 0.01–7.10 1.00
Textured implant (vs. smooth) 2.83 0.24–21.90 0.24
No insurance vs. any insurance 0 0.00–4.72 0.58
County median household income > state median household income 0 0.00–2.57 0.33

*Among the 109 survey respondents. Implant surface type not documented in the electronic medical record for two patients.

Age listed as a continuous variable.

OR = 0 because of one cell in the contingency table with a value of 0.

Table 3. -
Two-Way Comparison of Individual Characteristics and Adherence to U.S. Food and Drug Administration Recommendation

Characteristic Adherent to FDA Recommendation (No. of Patients) Not Adherent to FDA Recommendation (No. of Patients)
Surgery type

 Cosmetic augmentation 1 22
 Reconstructive 5 81
Implant type

 Textured 2 15
 Smooth 4 86
County median household income

 Greater than state 0 27
 Less than state 6 76

FDA, U.S. Food and Drug Administration.

*Among the 109 survey respondents. Implant surface type not documented in the electronic medical record for two patients.

Table 4. -
Logistic Regression Analysis of Surgery Type, Presence of Insurance, Age, and Median Household Income and Adherence to U.S. Food and Drug Administration Recommendation

Characteristic OR 95% CI
Age at the time of surgery 0.97 0.90–1.05 0.44
Cosmetic augmentation breast surgery (vs. reconstruction) 0.87 0.07–6.64 0.90
Textured implant (vs. smooth) 2.76 0.43–15.02 0.26
Any insurance vs. none 1.89 0.17–263.99 0.66
County median household income > state median household income 0.25 0.00–2.26 0.26

*Among the 109 survey respondents. Implant surface type not documented in the electronic medical record for two patients.

A univariable logistic regression model was fit to estimate the effect of age as a continuous variable on U.S. Food and Drug Administration recommendation adherence.

Patients who underwent magnetic resonance imaging cited the following as reasons for imaging: cancer surveillance (n = 8), implant concern (n = 6), cancer concern (n = 3), and/or routine implant surveillance (n = 1). On electronic medical record review, 11 obtained for any reason were negative for acute pathology, two were concerning for malignancy (one patient underwent lumpectomy and one had benign papilloma on biopsy), and one was aborted because of contrast allergy. No implant abnormalities were detected by magnetic resonance imaging. Among patients who had not undergone postoperative magnetic resonance imaging, three were aware of the recommendation, but did not undergo testing because they expressed no concerns about their implants and were averse to magnetic resonance imaging.


Beginning in 2006, the U.S. Food and Drug Administration recommended that patients with silicone breast implants undergo routine surveillance magnetic resonance imaging to detect asymptomatic implant rupture beginning 3 years after implant placement and continuing every 2 years thereafter. Among patients included in this study, only 5.9 percent underwent magnetic resonance imaging following silicone breast implant placement in accordance with the recommendation and 92 patients were unaware of the recommendation, despite this having been discussed during perioperative clinic visits and summarized in supplemental information pamphlets. Low adherence suggests that, without repeated reinforcement, the importance of this recommendation may not be apparent to patients several years after surgery. Even patients who were aware of the recommendation elected not to undergo screening magnetic resonance imaging because they “didn’t like magnetic resonance imaging” or did not believe it necessary because “everything has been fine” in follow-up. Unfortunately, because routine, asymptomatic follow-up visits several years postoperatively may not be covered by insurance policies and cosmetic procedures/follow-up visits are not covered by insurance, many patients may not return for follow-up around the time magnetic resonance imaging would be due. In addition, our hospital serves a large rural patient population where patients often live several hours away and/or have limited transportation options, which may be additional barriers to routine follow-up, particularly if patients are otherwise asymptomatic. Similar challenges likely exist in other rural settings. Although this finding may not be generalizable to urban settings, other constraints could exist in those settings.

Whether magnetic resonance imaging is the optimal imaging modality, uncertainty about its clinical utility, and concerns about the economic cost of the U.S. Food and Drug Administration recommendation are topics of debate, and many plastic surgeons do not agree with the recommendation.8,9 Various imaging modalities, including mammography, ultrasound, computed tomography, and magnetic resonance imaging, have been used to evaluate implant rupture. Magnetic resonance imaging has the highest sensitivity and specificity because of the ability to suppress or enhance the silicone signal.4,10–12 However, magnetic resonance imaging frequently yields incidental findings of limited clinical significance. A small percentage of magnetic resonance imaging scans also demonstrate incidental extramammary lesions (most commonly in the liver), resulting in recommendations for further imaging and biopsies, which can increase patient anxiety and financial burden.13 Previous meta-analyses argue that magnetic resonance imaging may have a sufficient positive predictive value to guide decision-making about implant removal only in symptomatic women,14 but there is no conclusive evidence that magnetic resonance imaging screening reduces morbidity in asymptomatic women.15 In addition, studies examining the role of magnetic resonance imaging or ultrasound in detecting rupture are limited by selection bias and other methodologic concerns.16,17

Mammography is inexpensive and can accurately detect extracapsular rupture,9 but may miss a large percentage of intracapsular ruptures.18 The ability to identify both intracapsular and extracapsular rupture is important for surgical planning. Management of a ruptured implant may require capsulectomy, implant removal, and/or local lymphadenectomy.19,20 In addition, although rare, the breast compression required for mammography could increase the risk of implant rupture. A review of the U.S. Food and Drug Administration’s adverse events database for breast implants as of 2004 revealed only 41 cases of rupture during mammography, of hundreds of thousands of women with breast implants who undergo mammography annually.21 Computed tomography has limited ability to detect extracapsular rupture, is expensive, and exposes patients to radiation. Ultrasound does not expose patients to ionizing radiation, is inexpensive, is widely available, and may be used in claustrophobic patients or patients who cannot otherwise undergo magnetic resonance imaging. Because it is operator dependent, however, it is an inconsistent screening modality.9

Long-term screening creates an enormous financial burden to both patients and insurance companies.9 Despite the U.S. Food and Drug Administration recommendation that asymptomatic patients undergo routine magnetic resonance imaging surveillance for silicone implant rupture, lack of insurance coverage may impede adherence to this recommendation (Table 5). (See Table, Supplemental Digital Content 3, which shows insurance company magnetic resonance imaging coverage policies, https://links.lww.com/PRS/F190.) Our review of Blue Cross Blue Shield online medical policies across 50 states revealed that 52 percent of policies (n = 26) stated that symptoms suggestive of implant rupture, or prior inconclusive mammography or breast ultrasound examinations, were prerequisites for magnetic resonance imaging coverage. Furthermore, 24 percent (n = 12) explicitly categorized magnetic resonance imaging screening for asymptomatic patients as “not medically necessary.” For many states, no specific coverage information could be found about imaging for breast implant rupture, explantation, or replacement of ruptured implants. Further adding to confusion, coverage policies often vary by state. Moreover, although insurance companies may cover magnetic resonance imaging scans for breast reconstruction patients, these policies may not apply to those who have undergone breast augmentation. Although we did not identify a significant association between insurance coverage and magnetic resonance imaging adherence, the overall sample size was small and the number of patients with each type of insurance may have been too limited to detect differences related to this or other health economic factors.

Table 5. -
Insurance Company Coverage Policies for Magnetic Resonance Imaging Based on Presentation/Indication

Yes No Not Specified
MRI covered for asymptomatic rupture screening 15 12 23
MRI covered if symptomatic and/or prior mammography or US inconclusive 26

Explantation covered for reconstructive patients 32

Explantation covered for cosmetic patients 9* 6 35
Implant replacement covered for reconstructive patients 10

Implant replacement covered for cosmetic patients 6 on a case-by-case basis 3 41

MRI, magnetic resonance imaging; US, ultrasound.

*Seven on a case-by-case basis, two without caveats.

Insurers’ determinations may draw from the American College of Radiology’s Appropriateness Criteria, which state that ultrasound and mammography are acceptable alternatives to magnetic resonance imaging for evaluating silicone implants, and that asymptomatic patients do not require imaging.22 The prevalence of rupture in asymptomatic patients is low (8 percent), compared with 33 percent in symptomatic patients. Ultrasound and mammography are less sensitive than magnetic resonance imaging in detecting implant rupture, particularly intracapsular rupture, but are less costly and may result in fewer false-positives and potentially unnecessary surgical intervention.8,9,23–25 In one analysis, ultrasound was more cost-effective for screening and treatment of identified ruptures in both asymptomatic and symptomatic patients, as compared with magnetic resonance imaging ($1090 and $1622 for ultrasound versus $2067 and $2143 for magnetic resonance imaging in asymptomatic and symptomatic patients, respectively), with cost defined as Medicare reimbursement.9

Residence in a county with a median annual household income above the state median was not associated with greater adherence to the U.S. Food and Drug Administration screening recommendation. However, this aspect of the analysis was limited by sample size. A complete cost analysis is beyond the scope of this study, but future studies should analyze out-of-pocket expenses versus those covered by insurance; costs to the health care system versus the individual; and costs of potential associated imaging studies, clinic visits, and procedures.

At the U.S. Food and Drug Administration’s General and Plastic Surgery Devices Advisory Committee Meeting in March of 2019, the advisory panel modified its recommendations to specify magnetic resonance imaging beginning 5 to 6 years following implant placement and every 2 to 3 years thereafter, and suggested that ultrasound may be a more appropriate initial choice for screening asymptomatic patients, and that magnetic resonance imaging could be reserved for symptomatic patients or those with equivocal ultrasound findings.26–28 Notably, among patients in our study who had undergone magnetic resonance imaging after implant placement, nine had implants placed within the previous 5 years, whereas three had them placed more than 5 years prior. In addition, most patients who underwent magnetic resonance imaging did so for cancer-related reasons, rather than implant concerns, suggesting that, even with the U.S. Food and Drug Administration’s revised guidelines, adherence rates may remain low.

Updated U.S. Food and Drug Administration recommendations recognize ultrasound as an alternative to magnetic resonance imaging. In our study, 19 patients had undergone ultrasound since implant placement. Reasons for ultrasound were not the focus of this study; however, electronic medical record review indicated that most patients underwent ultrasound for cancer-related indications. Given the increased accessibility and lower cost of ultrasound, patients may be more likely to adhere to these updated guidelines and physicians may feel more comfortable recommending screening. Because data collection for our study was conducted before these updated guidelines, whether this would impact patients in our study is unclear.

Several limitations of our study should be noted, including those related to the survey methodology and sample size. Given the span of time since implant placement and the distance that many patients live from our institution, a telephone survey was an accessible way to follow up with patients. Although we acknowledge that sample size limits the statistical power of the findings, we highlight opportunities for future meta-analyses to incorporate our results and weigh the evidence appropriately. Future studies should assess patient adherence at the population-level and analyze the costs associated with imaging surveillance. In addition, the U.S. Food and Drug Administration updated its surveillance recommendations after data collection for this study was already underway. We conducted our analysis based on the previous recommendation, as this was in place when patients in this study underwent implant placement. However, although the timeline for the recommended surveillance has changed, the majority of patients in our study were unaware of recommendations and generally underwent imaging for cancer-related reasons, rather than implant concerns. Furthermore, those who were aware of the recommendation elected not to undergo screening because of having no implant concerns or aversion to magnetic resonance imaging testing. This suggests that modifying the timeline is unlikely to improve adherence rates. Future studies should examine the effects of various forms of reminder interventions on patient awareness of and adherence to magnetic resonance imaging screening recommendations.


Only a minority of respondents undergo magnetic resonance imaging in accordance with the U.S. Food and Drug Administration recommendation, and most patients are unaware of the recommendation, despite discussion of the issue perioperatively and receiving supplemental information pamphlets. The low adherence highlights a limitation of current federal recommendations for surveillance. These results may not be generalizable to other populations and are limited by potential selection or reporter bias. Additional research is needed to better characterize adherence to magnetic resonance imaging surveillance recommendations, identify barriers to implementation, and determine whether this recommendation remains valid.


Data analysis was performed with the help of statisticians at the support of the Dartmouth Clinical and Translational Science Institute, under award number UL1TR001086 from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. There are no other sources of funding for this project.


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