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Appropriateness Criteria

Reference Study Type Patients/Events Study Objective(Purpose of Study) Study Results Study Quality
1. U.S. FDA.  U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health. Breast Implants - Certain Labeling Recommendations to Improve Patient Communication. Guidance for Industry and Food and Drug Administration Staff.  Available at: https://www.fda.gov/media/131885/download. Review/Other-Dx N/A No abstract available N/A 4
2. Adrada BE, Whitman GJ, Crosby MA, Carkaci S, Dryden MJ, Dogan BE. Multimodality Imaging of the Reconstructed Breast. [Review]. Curr Probl Diagn Radiol. 44(6):487-95, 2015 Nov-Dec. Review/Other-Dx N/A To illustrate the imaging characteristics and pathologic findings associated with various types of breast reconstruction in women who have undergone mastectomy to treat breast cancer. No results stated in abstract. 4
3. Bennett KG, Qi J, Kim HM, Hamill JB, Pusic AL, Wilkins EG. Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction. JAMA Surg. 153(10):901-908, 2018 10 01. Observational-Dx 2343 patients To assess 2-year complication rates across common techniques for postmastectomy reconstruction in a multicenter patient population. A total of 2343 patients (mean [SD] age, 49.5 [10.1] years; mean [SD] body mass index, 26.6 [5.7]) met the inclusion criteria. A total of 1525 patients (65.1%) underwent EI reconstruction, with 112 (4.8%) receiving DTI reconstruction, 85 (3.6%) pTRAM flaps, 95 (4.1%) fTRAM flaps, 390 (16.6%) DIEP flaps, 71 (3.0%) LD flaps, and 65 (2.8%) SIEA flaps. Overall, complications were noted in 771 (32.9%), with reoperative complications in 453 (19.3%) and wound infections in 230 (9.8%). Two years postoperatively, patients undergoing any autologous reconstruction type had significantly higher odds of developing any complication compared with those undergoing EI reconstruction (pTRAM flap: odds ratio [OR], 1.91; 95% CI, 1.10-3.31; P = .02; fTRAM flap: OR, 2.05; 95% CI, 1.24-3.40; P = .005; DIEP flap: OR, 1.97; 95% CI, 1.41-2.76; P < .001; LD flaps: OR, 1.87; 95% CI, 1.03-3.40; P = .04; SIEA flap: OR, 4.71; 95% CI, 2.32-9.54; P < .001). With the exception of LD flap reconstructions, all flap procedures were associated with higher odds of reoperative complications (pTRAM flap: OR, 2.48; 95% CI, 1.33-4.64; P = .005; fTRAM flap: OR, 3.02; 95% CI, 1.73-5.29; P < .001; DIEP flap: OR, 2.76; 95% CI, 1.87-4.07; P < .001; SIEA flap: OR, 2.62; 95% CI, 1.24-5.53; P = .01) compared with EI techniques. Of the autologous reconstructions, only patients undergoing DIEP flaps had significantly lower odds of infection compared with those undergoing EI procedures (OR, 0.45; 95% CI, 0.25-0.29; P = .006). However, DTI and EI procedures had higher failure rates (EI and DTI techniques, 7.1%; pTRAM flap, 1.2%; fTRAM flap, 2.1%; DIEP flap, 1.3%; LD flap, 2.8%; and SIEA flap, 0%; P < .001). 3
4. Green LA, Karow JA, Toman JE, Lostumbo A, Xie K. Review of breast augmentation and reconstruction for the radiologist with emphasis on MRI. [Review]. Clin Imaging. 47:101-117, 2018 Jan - Feb. Review/Other-Dx N/A To review imaging of the augmented and reconstructed breast, as well as complications, with a focus on Magnetic Resonance Imaging (MRI). No results stated in abstract. 4
5. U.S. FDA.  Center for Devices and Radiological Health. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses.  Available at: http://wayback.archive-it.org/7993/20171115053750 Review/Other-Dx N/A No abstract available N/A 4
6. Lamaris GA, Butler CE, Deva AK, et al. Breast Reconstruction Following Breast Implant-Associated Anaplastic Large Cell Lymphoma. Plast Reconstr Surg. 143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):51S-58S, 2019 03. Review/Other-Dx 66 BIA-ALCL patients To report a case series of BIA-ALCL reconstruction with proposals for timing and technique selection. We treated 66 consecutive BIA-ALCL patients and 18 (27%) received reconstruction. Seven patients (39%) received immediate reconstruction, and 11 (61%) received delayed reconstruction. Disease stage at presentation was IA (T1N0M0 disease confined to effusion or a layer on luminal side of capsule with no lymph node involvement and no distant spread) in 56%, IB in 17%, IC (T3N0M0 cell aggregates or sheets infiltrating the capsule, no lymph node involvement and no distant spread) in 6%, IIA (T4N0M0 lymphoma infiltrating beyond the capsule, no lymph node involvement and no distant spread) in 11%, and III in 11%. Types of reconstruction included smooth implants (72%), immediate mastopexy (11%), autologous flaps (11%), and fat grafting (6%). Outcomes included no surgical complications, but 1 patient progressed to widespread bone metastasis (6%); ultimately, all patients achieved complete remission. Ninety-four percent were satisfied/highly satisfied with reconstructions, whereas 6% were highly unsatisfied with immediate smooth implants. 4
7. Brody GS, Deapen D, Taylor CR, et al. Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg 2015;135:695-705. Review/Other-Dx 37 studies (173 cases) To review 37 articles in the world literature reporting on 79 patients and collected another 94 unreported cases as of the date of submission. ALCL lesions first presented as late peri-implant seromas, a mass attached to the capsule, tumor erosion through the skin, in a regional node, or discovered during revision surgery. The clinical course varied widely from a single positive cytology result followed by apparent spontaneous resolution, to disseminated treatment-resistant tumor and death. There was no preference for saline or silicone fill or for cosmetic or reconstructive indications. Where implant history was known, the patient had received at least one textured-surface device. Extracapsular dissemination occurred in 18 cases; nine of those were fatal. Histochemical markers were primarily CD-30 and Alk-1. Other markers occurred at a lower frequency. Risk estimates ranged from one in 500,000 to one in 3 million women with implants. 4
8. Clemens MW, Horwitz SM. NCCN Consensus Guidelines for the Diagnosis and Management of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthet. surg. j.. 37(3):285-289, 2017 03 01. Review/Other-Dx N/A To summarize the essential recommendations and optimal therapeutic strategies of the NCCN guidelines critical to the plastic surgery community. No results available 4
9. DeCoster RC, Lynch EB, Bonaroti AR, et al. Breast Implant-associated Anaplastic Large Cell Lymphoma: An Evidence-based Systematic Review. Ann Surg. 273(3):449-458, 2021 03 01. Review/Other-Dx 7 studies To broaden physician awareness across diverse specialties, particularly among general practitioners, breast surgeons, surgical oncologists, and other clinicians who may encounter patients with breast implants in their practice.To synthesize and critically appraise current clinical guidelines and recommendations while highlighting advances in diagnosis and treatment and raising awareness for this emerging disease. The clinical knowledge of BIA-ALCL has evolved rapidly over the last several years with major advances in diagnosis and treatment, including en bloc resection as the standard of care. Despite a limited number of high-quality clinical studies comprised mainly of Level III and Level V evidence, current evidence aligns with established NCCN consensus guidelines. When diagnosed and treated in accordance with NCCN guidelines, BIA-ALCL carries an excellent prognosis. 4
10. Goldammer F, Pinsolle V, Dissaux C, Pelissier P. Accuracy of mammography, sonography and magnetic resonance imaging for detecting silicone breast implant ruptures: A retrospective observational study of 367 cases. Ann Chir Plast Esthet. 66(1):25-41, 2021 Feb. Observational-Dx 234 patients To assess the efficacy of magnetic resonance imaging, ultrasound and mammography in detecting breast implant rupture. Two hundred and thirty-four (234) patients were included; 213 mammographies, 295 ultrasounds and 160 magnetic resonance imagings were carried out. While 114 clinical ruptures were confirmed, 253 implants remained intact. Magnetic resonance imaging was the most sensitive (99%); outperforming mammography (sensitivity: 70%). Mammography was the most accurate in diagnosis of intact implant (specificity: 93%), and magnetic resonance imaging was second (specificity: 78%). Ultrasound was rated intermediately. Positive mammography signifies a rupture in 84% of cases, whereas magnetic resonance imaging (positive predictive value: 78%) can be mistaken in 20% of cases. Negative ultrasound and magnetic resonance imaging rule out a rupture (negative predictive value of 93% and 99% respectively). Mammography and ultrasound are more accurate than magnetic resonance imaging in diagnosing implant rupture (positive likelihood ratios of 9.78, 8.24 and 4.44 respectively). Magnetic resonance imaging provides convincing affirmation of implant integrity (negative likelihood ratio: 0.02). 4
11. Adrada BE, Miranda RN, Rauch GM, et al. Breast implant-associated anaplastic large cell lymphoma: sensitivity, specificity, and findings of imaging studies in 44 patients. Breast Cancer Res Treat. 2014;147(1):1-14. Observational-Dx 79 women. To describe the imaging findings of patients with breast implant-associated anaplastic large cell lymphoma (BIA ALCL) and determine their sensitivity and specificity in the detection of the presence of an effusion or a mass related to BIA ALCL. The sensitivity for detecting an effusion was 84, 55, 82, and 38 %, and for detecting a mass was 46, 50, 50, and 64 %, by US, CT, MRI, and PET,respectively. The sensitivity of mammography in the detection of an abnormality without distinction of effusion or mass was 73 %, and specificity 50 %. Progression-free survival was worse in patients with an implant-associated mass (p = 0.001). 3
12. Gunawardana RT, Dessauvagie BF, Taylor DB. Breast implant-associated anaplastic large cell lymphoma, an under-recognised entity. [Review]. J Med Imaging Radiat Oncol. 63(5):630-638, 2019 Oct. Review/Other-Dx N/A To review the clinical, imaging and pathology features of BIA-ALCL. In addition, the current recommended management guidelines for suspected cases are discussed. No results available 4
13. Sharma B, Jurgensen-Rauch A, Pace E, et al. Breast Implant-associated Anaplastic Large Cell Lymphoma: Review and Multiparametric Imaging Paradigms. [Review]. Radiographics. 40(3):609-628, 2020 May-Jun. Review/Other-Dx N/A To evaluate available evidence in this evolving field; detail key indications, strengths, and limitations of the panoply of radiologic techniques for BIA-ALCL; and propose multiparametric imaging paradigms for management of the peri-implant effusion and mass-forming or advanced disease subtypes, with the goal of accurate optimal patient care. To predict a future model of multimodal assessment using novel imaging and molecular techniques and define key research directions. No results available 4
14. Mainiero MB, Moy L, Baron P, et al. ACR Appropriateness Criteria® Breast Cancer Screening. J Am Coll Radiol 2017;14:S383-S90. Review/Other-Dx N/A To provide evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for breast cancer screening. No results stated in abstract. 4
15. Brown A, Lourenco AP, Niell BL, et al. ACR Appropriateness Criteria® Transgender Breast Cancer Screening. J Am Coll Radiol 2021;18:S502-S15. Review/Other-Dx N/A Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for transgender breast cancer screening. No results stated in abstract. 4
16. Middleton MS.. MR evaluation of breast implants. [Review]. Radiol Clin North Am. 52(3):591-608, 2014 May. Review/Other-Dx N/A To describe the rationale and indications for breast implant-related magnetic resonance (MR) imaging, alone or in combination with breast cancer-related MR imaging. No results stated in abstract. 4
17. Lalonde L, David J, Trop I. Magnetic resonance imaging of the breast: current indications. Can Assoc Radiol J 2005;56:301-8. Review/Other-Dx N/A To review current indications for MR imaging of the breast. MRI is recognized as the most sensitive modality for the detection of invasive breast cancer. Several valuable clinical applications of MRI have emerged for breast cancer detection and diagnosis from clinical investigations. Breast MRI is helpful for women diagnosed with breast cancer who contemplate breast conserving surgery; it provides valuable information on the extent of the disease. MRI can also help assess for residual invasive cancer in patients who have undergone lumpectomy with positive margins at pathology. It is very reliable in differentiating scar tissue from recurrence at the lumpectomy site. MRI is also reliable in finding a breast cancer in women with axillary nodal metastases and unknown primary tumour. MRI can help to monitor the response to chemotherapy. Breast MRI could be a better screening tool than mammography in women with very high risks of developing breast cancer, such as breast cancer gene carriers and patients treated with chest radiation. Other potential uses of MRI include evaluation of the integrity of silicone breast implants and evaluation of the parenchyma in women with silicone gel implants or free injection of silicone gel. However, like any other technique, breast MRI has some drawbacks, including low-to-moderate specificity, high costs, and variability in technique and interpretation. 4
18. Seiler SJ, Sharma PB, Hayes JC, et al. Multimodality Imaging-based Evaluation of Single-Lumen Silicone Breast Implants for Rupture. [Review]. Radiographics. 37(2):366-382, 2017 Mar-Apr. Review/Other-Dx N/A To describe the strengths and limitations of each modality for identification of rupture, discuss the various imaging features signifying rupture for each modality, and highlight important imaging findings that may mimic those of rupture. No results available 4
19. Holmich LR, Fryzek JP, Kjoller K, et al. The diagnosis of silicone breast-implant rupture: clinical findings compared with findings at magnetic resonance imaging. Ann Plast Surg. 2005;54(6):583-589. Observational-Dx 55 women with 109 implants To evaluate the usefulness of clinical examination in the evaluation of breast-implant integrity, using the diagnosis at magnetic resonance imaging (MRI) as the "gold standard." Twenty-four of 109 implants were clinically diagnosed with possible rupture or rupture. Eighteen of the 24 implants were ruptured according to the MRI examination (75%). Eighty-five implants were clinically classified as intact, and 43 of these were actually ruptured at MRI (51%). The sensitivity of the clinical examination for diagnosing rupture was thus 30% and the specificity 88%. The positive predictive value of a clinical diagnosis of rupture was 75%, and the negative predictive value was 49%. 4
20. Brenner RJ. Evaluation of breast silicone implants. Magn Reson Imaging Clin N Am 2013;21:547-60. Review/Other-Dx N/A To outline the approach toward optimal imaging and expected results. No results stated in abstract. 4
21. McCarthy CM, Pusic AL, Kerrigan CL. Silicone breast implants and magnetic resonance imaging screening for rupture: do U.S. Food and Drug Administration recommendations reflect an evidence-based practice approach to patient care? Plast Reconstr Surg 2008;121:1127-34. Review/Other-Dx N/A To (1) outline the principles of a screening program; (2) examine the evidence for a magnetic resonance imaging screening program for the detection of silent implant rupture; (3) review lessons learned from the premature proliferation of unproven screening tests in other clinical arenas; and (4) define the process of and the advantages to using shared decision making in the setting of clinical uncertainty. Screening decisions are complex, and relevant information is lacking. Although the detection of silent silicone implant ruptures may prove to be prudent, there is no conclusive evidence at this time to show that using magnetic resonance imaging screening of asymptomatic women leads to a reduction in patient morbidity. Furthermore, based on existing data, it is unclear whether the potential benefits of screening magnetic resonance imaging tests outweigh the risks and potential costs for the patient. 4
22. Collis N, Litherland J, Enion D, Sharpe DT. Magnetic resonance imaging and explantation investigation of long-term silicone gel implant integrity. Plast Reconstr Surg 2007;120:1401-06. Observational-Dx 149 patients; 21 with explantation To present the results of a magnetic resonance imaging study, examining one manufacturer’s third-generation textured silicone gel breast implants placed in a subglandular position. One hundred forty-nine patients with bilateral subglandular implants (median +/- SD age, 8.9 +/- 2.3; range, 4.8 to 13.5 years) were imaged and reported by two independent radiologists. Twenty-three patients were reported to have 33 radiologically ruptured implants. Twenty-one patients (30 radiologically ruptured implants) agreed to explantation. Statistical analysis using maximum likelihood estimation of survival curve for cross-sectional data suggests that implant rupture starts at 6 to 7 years and that by 13 years approximately 11.8 percent of implants will have ruptured. 2
23. Heden P, Bone B, Murphy DK, Slicton A, Walker PS. Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation. Plast Reconstr Surg. 2006;118(6):1281-1287. Observational-Tx 144 patients To evaluate the intermediate to long-term safety and effectiveness for Inamed Style 410 cohesive silicone gel implants through magnetic resonance imaging,clinical examination, and quality-of-life assessment. The 144 subjects provided 286 implants for magnetic resonance imaging assessment, with a median implantation time of 6 years (range, 5 to 9 years). Overall, 99.0 percent of implants showed no evidence of rupture, 0.3 percent showed evidence of rupture, and 0.7 percent were indeterminate. The most common complication noted at physical examination was capsular contracture (5.6 percent). All other complications occurred in less than 3 percent of subjects. Quality-of-life results found an improvement in overall sense of well-being for 87 percent of subjects. Most compelling is that 97 percent stated an overall feeling that their breast implantation had been advantageous. 3
24. Heden P, Nava MB, van Tetering JP, et al. Prevalence of rupture in inamed silicone breast implants. Plast Reconstr Surg. 2006;118(2):303-308; discussion 309-312 Observational-Tx 106 patients with 199 implants To acquire long-term rupture data specific to Inamed's third-generation silicone breast implants using magnetic resonance imaging technology. A total of 199 implants were evaluated, with a median implantation time of 10.9 years (range, 9.5 to 13.2 years). Overall, 183 implants (92.0 percent) showed no evidence of rupture, 12 (6.0 percent) showed evidence of rupture, and four (2.0 percent) were indeterminate. All indeterminate evaluations were considered ruptures, providing a worst-case rupture prevalence of 8.0 percent. 3
25. Maxwell GP, Van Natta BW, Murphy DK, Slicton A, Bengtson BP. Natrelle style 410 form-stable silicone breast implants: core study results at 6 years. Aesthet Surg J 2012;32:709-17. Observational-Tx 941 women To update the safety and effectiveness findings for the Natrelle Style 410 implants through 6 years of study. As expected after breast implantation, capsular contracture (CC) was one of the most common complications, with 6-year risk rates of 4.6% for augmentation, 6.9% for revision-augmentation, 10.7% for reconstruction, and 18.3% for revision-reconstruction. The rates for CC among augmentations and revision-augmentations were significantly lower with the Natrelle 410 implants than with other standard gel implants. The rupture rate (confirmed plus suspected) across all cohorts was 6.4% by subject and 3.8% by implant. The most common reasons for reoperation were style or size change (augmentation), implant malposition (revision-augmentation), scarring (reconstruction), and CC (revision-reconstruction). The satisfaction rate exceeded 80% in all cohorts. 1
26. Scaranelo AM, Marques AF, Smialowski EB, Lederman HM. Evaluation of the rupture of silicone breast implants by mammography, ultrasonography and magnetic resonance imaging in asymptomatic patients: correlation with surgical findings. Sao Paulo Med J 2004;122:41-7. Observational-Dx 44 patients with 83 implants To compare the efficacy of mammography, sonography and magnetic resonance imaging in the detection of breast implant rupture in an asymptomatic population. The respective sensitivity and specificity of mammography were 20% and 89%; sonography, 30% and 81%; and magnetic resonance imaging, 64% and 77%. The differences between patients with breast implants for cosmetic and oncological reasons were discussed. 2
27. Rietjens M, Villa G, Toesca A, et al. Appropriate use of magnetic resonance imaging and ultrasound to detect early silicone gel breast implant rupture in postmastectomy reconstruction. Plast Reconstr Surg. 2014;134(1):13e-20e. Observational-Dx 102 patients To compare magnetic resonance imaging and ultrasound evaluation with intraoperative findings and provide a reliable description of the occurrence of each radiological sign. Magnetic resonance imaging performs better than ultrasound for diagnosis of breast implant rupture, with overall accuracies of 94 and 72 percent, respectively. The negative predictive value of ultrasound was 85 percent, meaning that in the case of negative ultrasound findings, magnetic resonance imaging may be avoided. Teardrop sign and water droplets are the most common findings on magnetic resonance imaging. 3
28. Holmich LR, Vejborg I, Conrad C, Sletting S, McLaughlin JK. The diagnosis of breast implant rupture: MRI findings compared with findings at explantation. Eur J Radiol 2005;53:213-25. Observational-Dx 64 women with 188 implants To evaluate the accuracy of Magnetic Resonance Imaging (MRI) as performed according to a strict study protocol in diagnosing rupture of silicone breast implants. At MRI, 66 implants were diagnosed as ruptured, nine as possibly ruptured and 43 as intact. Among the ruptured implants, 27 were categorized as extracapsular. At surgery, on average 297 days after the MRI, 65 of the 66 rupture diagnoses were confirmed, as were 20 of the cases with extracapsular silicone. Eight of the nine possibly ruptured implants were in fact ruptured at surgery. Thirty-four of the 43 intact implants were described as intact at surgery. When categorising possible ruptures as ruptures, there were one false positive and nine false negative rupture diagnoses at MRI yielding an accuracy of 92%, a sensitivity of 89%, and a specificity of 97%. Correspondingly, the predictive value of a positive MRI examination was 99% and the predictive value of a negative MRI examination was 79%. 2
29. Gorczyca DP, Gorczyca SM, Gorczyca KL. The diagnosis of silicone breast implant rupture. [Review] [29 refs]. Plast Reconstr Surg. 120(7 Suppl 1):49S-61S, 2007 Dec. Review/Other-Dx N/A To illustrate the spectrum of imaging appearances of normal silicone gel implants and the appearances of silicone breast implant ruptures. No results stated in abstract. 4
30. Lake E, Ahmad S, Dobrashian R. The sonographic appearances of breast implant rupture. Clin Radiol. 2013;68(8):851-858. Review/Other-Dx N/A To demonstrate normal appearances and sonographic signs of implant rupture. No results stated in abstract. 4
31. Yang N, Muradali D. The augmented breast: a pictorial review of the abnormal and unusual. AJR Am J Roentgenol 2011;196:W451-60. Review/Other-Dx N/A To review the multimodality imaging features of breast augmentation complications as well as appearances of unusual breast augmentation techniques. Cosmetic breast augmentation is an increasingly common procedure performed in our society. Although breast prosthesis implantation is the most common technique, other unusual techniques such as autologous fat implantation as well as direct liquid silicone and paraffin injections have also been used. 4
32. Bengtson BP, Eaves FF, 3rd. High-resolution ultrasound in the detection of silicone gel breast implant shell failure: background, in vitro studies, and early clinical results. Aesthet Surg J 2012;32:157-74. Observational-Dx Phase 3: 15 patients To evaluate the feasibility of portable, high-resolution ultrasound (HRUS) for imaging of silicone gel breast implants and perform preliminary comparisons of HRUS to MRI in the assessment of both intact and failed implants in a clinical setting by both radiologists and plastic surgeons. In Phase 1, all hardware models easily detected both intact and intentionally damaged shells in currently marketed fourth-generation responsive gel implants and in investigational, fifth-generation highly-cohesive gel devices. Although multiple transducers were able to detect shell failure, the 12-MHz head produced the best images at the normal clinical depth range. In Phase 2, confirmatory HRUS scans correctly identified the side of rupture and were consistent with MRI and surgical findings in all patients. In Phase 3, MRI, surgeon-performed HRUS, and radiologist-performed HRUS scans were all accurate in predicting implant shell integrity in 29 of 29 imaged breasts (100%) as confirmed at the time of surgery in both symptomatic and asymptomatic patients. 2
33. Berry MG, Stanek JJ. PIP implant biodurability: a post-publicity update. J Plast Reconstr Aesthet Surg 2013;66:1174-81. Observational-Dx 460 patients To estimate rupture prevalence, assess the media effect and evaluate contemporary ultrasound scan (USS) accuracy. Kaplan-Meier analysis places 10-year PIP mammary implant survival between 60 (95% confidence interval (CI): 54-67) and 81% (95% CI: 78-85). Post-publicity evaluees were found to have occult device failure in 31.6%. Of 85 patients who had definitive confirmation of USS findings by surgical exploration, 79 (92.9%) were completely accurate. USS in our series had a sensitivity of 97.3% and specificity of 93.1%. 3
34. Di Benedetto G, Cecchini S, Grassetti L, et al. Comparative study of breast implant rupture using mammography, sonography, and magnetic resonance imaging: correlation with surgical findings. Breast J 2008;14:532-7. Observational-Dx 63 women with 82 implants To evaluate the accuracy of mammography, ultrasonography, and magnetic resonance imaging (MRI), in the detection of breast implant rupture and to make a correlation with findings at explantation. The respective sensitivity and specificity of investigations are reported. Our experience suggests that MRI is the more accurate method for identification of breast implant rupture, even if it should be performed following the diagnostic algorithm proposed. 3
35. Helyar V, Burke C, McWilliams S. The ruptured PIP breast implant. Clin Radiol 2013;68:845-50. Review/Other-Dx N/A To discuss possible approaches to screening the PIP cohort and the salient characteristics of a ruptured implant. No results stated in abstract. 4
36. American College of Radiology. ACR Appropriateness Criteria®: Palpable Breast Masses. Available at: https://acsearch.acr.org/docs/69495/Narrative/. Review/Other-Dx N/A To provide recommendations for the diagnosis of palpable breast masses. No results stated in abstract. 4
37. Song JW, Kim HM, Bellfi LT, Chung KC. The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis. Plast Reconstr Surg 2011;127:1029-44. Meta-analysis 21 studies To examine the effect of study design biases on the estimation of magnetic resonance imaging diagnostic accuracy measures. Among 1175 identified articles, 21 met the inclusion criteria. Most studies using magnetic resonance imaging (10 of 16) and ultrasound (10 of 13) examined symptomatic subjects. Magnetic resonance imaging studies evaluating symptomatic subjects had 14-fold higher diagnostic accuracy estimates compared with studies using an asymptomatic sample (relative diagnostic odds ratio, 13.8; 95 percent confidence interval, 1.83 to 104.6) and 2-fold higher diagnostic accuracy estimates compared with studies using a screening sample (relative diagnostic odds ratio, 1.89; 95 percent confidence interval, 0.05 to 75.7). M
38. Vestito A, Mangieri FF, Ancona A, Minervini C, Perchinunno V, Rinaldi S. Study of breast implant rupture: MRI versus surgical findings. Radiol Med (Torino). 117(6):1004-18, 2012 Sep. Observational-Dx 157 implants To evaluate the role of breast magnetic resonance (MR) imaging in the selective study breast implant integrity. The linguine and the salad-oil signs were statistically the most significant signs for diagnosing intracapsular rupture; the presence of siliconomas/seromas outside the capsule and/or in the axillary lymph nodes calls for immediate explantation. 3
39. Rukanskiene D, Bytautaite G, Cesnauskaite A, Pilipaityte L, Astrauskas T, Jonaitiene E. The Value of Ultrasound in the Evaluation of the Integrity of Silicone Breast Implants. Medicina (Kaunas). 57(5), 2021 May 03. Observational-Dx 76 women with bilateral breast implants (91 with intact implants and 51 with ruptured implants) To evaluate the diagnostic value of ultrasound (US) in the evaluation of the integrity of silicone breast implants and identify the main sign of intact and ruptured breast implants. In this study, 76 women with bilateral breast implants (n = 152) were reviewed. On a US examination, ruptured implants were found in 41.1% (n = 61) of the cases; of them, 78.7% (n = 48) of the cases had =2 US signs of a ruptured implant, and in all these cases, implant rupture was confirmed at surgery. Overall, one US sign of a ruptured implant was found in 21.3% (n = 13) of the cases. Of them, inhomogeneous content in all cases (n = 3) was found in the intact implant group, and an abnormal implant shell was documented more often in the ruptured implant group, not intact one (n = 9, 90% vs. n = 1, 10%). US had a diagnostic accuracy of 94.7%, sensitivity of 98.3%, specificity of 89.2%, PPV of 93.4%, and NPV of 97.1% in the evaluation of implant integrity. 2
40. Klang E, Amitai MM, Raskin S, et al. Association between Enlarged Axillary Lymph Nodes and Silicone Breast Implant Ruptures seen on Magnetic Resonance Imaging. Isr Med Assoc J. 18(12):719-724, 2016 Dec. Observational-Dx Group A (45 women) and Group B (73 women) To investigate the association between enlarged axillary lymph nodes and silicone implant ruptures as seen on breast magnetic resonance imaging (MRI). Group A comprised 45 women with enlarged nodes. Intracapsular ruptures were associated with nodes (P = 0.005), while extracapsular ruptures showed a trend of association with nodes (P = 0.08). The prevalence of ruptures in the presence of nodes was 31.4%. Nodes associated with ruptures showed a strong silicone signal (P = 0.008) and absent enhancement (P = 0.005). Group B comprised 73 women with ruptures. Enlarged nodes were associated with both intra- and extracapsular ruptures (P < 0.001 and P = 0.002 respectively). The prevalence of nodes in the presence of ruptures was 22.2%. 3
41. Turton P, El-Sharkawi D, Lyburn I, et al. UK Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma on behalf of the Medicines and Healthcare products Regulatory Agency Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group. Br J Haematol. 192(3):444-458, 2021 02. Review/Other-Dx N/A To inform on a prospective change in practice, but also emphasize the need for a systematic approach to investigate patients who present with problems with their implants.To guide on diagnosis and treatment of BIA-ALCL, which builds further on the United States National Comprehensive Cancer Network (NCCN) and UK pathology guidelines to better reflect the unique differences that exist in UK practice where there is an approximate 50:50 split between implant operations in the private sector and those conducted within the National Health Service (NHS). No results provided 4
42. Rotili A, Ferrari F, Nicosia L, et al. MRI features of breast implant-associated anaplastic large cell lymphoma. [Review]. British Journal of Radiology. 94(1125):20210093, 2021 Sep 01.Br J Radiol. 94(1125):20210093, 2021 Sep 01. Review/Other-Dx N/A To illustrate the MRI signs of BIA-ALCL and correlate them with the corresponding pathology features in order to improve the knowledge of the principals MRI features of this type of lymphoma. No results available 4
43. Collado-Mesa F, Yepes MM, Net JM, Jorda M. Breast Implant-Associated Anaplastic Large Cell lymphoma: Brief overview of current data and imaging findings. [Review]. BREAST DIS.. 40(1):17-23, 2021. Review/Other-Dx N/A To summarize the available epidemiological and clinical data of Breast Implant-Associated Anaplastic Large Cell lymphoma, with an emphasis on imaging features. No results available 4
44. Bengtson B, Brody GS, Brown MH, et al. Managing late periprosthetic fluid collections (seroma) in patients with breast implants: a consensus panel recommendation and review of the literature. Plast Reconstr Surg 2011;128:1-7. Review/Other-Dx N/A To establish an algorithm for the management of patients who develop a late or delayed periprosthetic fluid collection. The consensus algorithm and treatment and management recommendations represent the consensus of the group. The group concluded that late periprosthetic fluid collection (arbitrarily defined as occurring = 1 year after implant) is an infrequently reported occurrence (0.1 percent) after breast implant surgery and that, at a minimum, management should include clinically indicated ultrasound-guided aspiration of fluid, with appropriate cultures and cytologic testing. Further evaluation and additional treatment is recommended for recurrence of periprosthetic fluid collection after aspiration, or clinical suspicion of infection or neoplasia. 4
45. Brody GS. Commentary on: Breast Implant–Associated Anaplastic Large Cell Lymphoma: Report of 2 Cases and Review of the Literature. Aesthet Surg J 2014;34:895-95. Review/Other-Dx N/A No abstract available No abstract available 4
46. Clemens MW, Medeiros LJ, Butler CE, et al. Complete surgical excision is essential for the management of patients with breast implant–associated anaplastic large-cell lymphoma. Journal of Clinical Oncology 2016;34:160. Observational-Dx 87 patients with BI-ALCL To evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach. The median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (P = .03). Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (P = .022) and EFS (P = .014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy. 4
47. Clemens MW, Miranda RN. Commentary on: CD30+ T Cells in Late Seroma May Not Be Diagnostic of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthet Surg J. 2017;37(7):776-778. Review/Other-Dx N/A No abstract available. No abstract available. 4
48. Gidengil CA, Predmore Z, Mattke S, van Busum K, Kim B. Breast implant-associated anaplastic large cell lymphoma: a systematic review. Plast Reconstr Surg. 2015;135(3):713-720. Review/Other-Dx 102 articles. To identify and analyze recently published cases of breast implant-associated anaplastic large cell lymphoma (ALCL), with an emphasis on diagnosis, staging, treatment, and outcomes. Of 248 identified articles, only 102 were relevant to breast implant-associated anaplastic large cell lymphoma (ALCL), and 27 were included in this study. Fifty-four cases of ALCL in patients with breast implants were identified. Detailed clinical information was lacking in many cases. Most presented with a seroma (76 percent), and approximately half were associated with the capsule (48 percent). Most presented as stage IE (61 percent). All but one case were ALK-negative. Most received chemotherapy (57 percent) and radiation therapy (48 percent), and 11 percent received stem cell transplants. Approximately one-quarter recurred, and 9 percent died. 4
49. Laurent C, Delas A, Gaulard P, et al. Breast implant-associated anaplastic large cell lymphoma: two distinct clinicopathological variants with different outcomes. Ann Oncol. 2016;27(2):306-314. Observational-Dx 19 women. To review the clinical, immunomorphologic, molecular and survival data of 19 cases collected from different institutions through Lymphopath over a 5-year period. The median age of the patients was 61 years and the median length between breast implant and breast implant associated anaplastic large cell lymphoma (i-ALCL) was 9 years. Most implants were silicone-filled and textured. Implant removal was performed in 17 out of 19 patients with additional treatment based on mostly CHOP (cyclophosphamide, adriamycin, vincristine and prednisone)or CHOP-like chemotherapy regimens (n = 10/19) or irradiation (n = 1/19). CHOP alone or ABVD (adriamycine, bleomycine, vinblastine and dacarbazine) following radiation without implant removal have been given in two patients. The two clinical presentations, i.e. effusion and less frequently tumor mass correlated with distinct histopathologic features: in situ i-ALCL (anaplastic cell proliferation confined to the fibrous capsule) and infiltrative i-ALCL (pleomorphic cells massively infiltrating adjacent tissue with eosinophils and sometimes Reed-Sternberg-like cells mimicking Hodgkin lymphoma). Malignant cells were CD30-positive, showed a variable staining for EMA and were ALK negative. Most cases had a cytotoxic T-cell immunophenotype with variable T-cell antigen loss and pSTAT3 nuclear expression. T-cell receptor genes were clonally rearranged in 13 out of 13 tested cases. After 18 months of median follow-up, the 2-year overall survival for in situ and infiltrative i-ALCL was 100% and 52.5%, respectively. 3
50. Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Aesthet Surg J 2019;39:S3-S13. Review/Other-Dx N/A To provide recommendations that focus on parameters for achieving reliable diagnosis and disease management and emphasize the critical role for complete surgical ablation. No results available 4
51. de Boer M, van der Sluis WB, de Boer JP, et al. Breast Implant-Associated Anaplastic Large-Cell Lymphoma in a Transgender Woman. Aesthet Surg J 2017;37:NP83-NP87. Review/Other-Dx 1 case To demonstrate in this case report that all patients who undergo breast implantation, including transgender women, are at risk of BIA-ALCL and to highlight the importance of cytomorphologic and immunohistochemical screening of seroma fluid in patients with late-onset periprosthetic seroma. Herein, we describe BIA-ALCL in a transgender woman. The patient received breast implants as part of her gender transition and was diagnosed with BIA-ALCL 20 years later. The patient underwent several revisional operations in the 20 years after her primary breast surgery to treat unexplained pain with low-grade fever, severe capsular contracture (Baker grade III-IV), and several instances of implant rupture. In July 2016, the patient presented to our office with "late-onset" periprosthetic seroma 5 years after her last revisional breast surgery. She was diagnosed with BIA-ALCL without capsular invasion based on results of cytologic analysis of the periprosthetic seroma and histologic evaluation of the periprosthetic capsule. This diagnosis was verified further by results of immunohistochemical testing, which indicated expression of CD30 and T-cell markers in the periprosthetic seroma only. 4
52. American College of Radiology. ACR Appropriateness Criteria® Radiation Dose Assessment Introduction. Available at: https://www.acr.org/-/media/ACR/Files/Appropriateness-Criteria/RadiationDoseAssessmentIntro.pdf. Review/Other-Dx N/A To provide evidence-based guidelines on exposure of patients to ionizing radiation. No abstract available. 4
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