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- Understanding breast implant illness, before and after explantation: a patient-reported outcomes study.Ann Plast Surg. 2020 Jul; 85: S82-S86
- Outcomes of implant removal and capsulectomy for breast implant illness in 248 patients.Plast Reconstr Surg Glob Open. 2021; 9: e3813
- Impact of capsulectomy type on post-explantation systemic symptom improvement: findings from the aserf systemic symoptoms in women-biospecimen analysis study: part 1.Aesthet Surg J. 2022; 42: 809-819
- Human adjuvant disease: presentation as a multiple sclerosis-like syndrome.South Med J. 1996; 89: 179-188
- Silicone implant incompatibility syndrome (SIIS): a frequent cause of ASIA (Shoenfeld’s syndrome).Immunol Res. 2013; 56: 293-298
- Silicone breast implants and autoimmune rheumatic diseases: myth or reality.Curr Opin Rheumatol. 2017; 29: 348-354
- Silicone-induced human adjuvant disease?.Ann Plast Surg. 1983; 10: 270-273
- Effects of silicone breast implants on human cell types in vitro: a closer look on host and implant.Aesthetic Plast Surg. 2022; 46: 2208-2217
- Women with silicone breast implants and unexplained systemic symptoms: a descriptive cohort study.Neth J Med. 2013; 71 (PMID: 24394743): 534-540
- Breast IMPLANT ILLNESS: A WAY FORWArd.Plast Reconstr Surg. 2019; 143: 74S-81S
Breast Implants - Certain Labeling Recommendations to Improve Patient Communication Guidance for Industry and Food and Drug Administration Staff; Document issued on September 29, 2020. The draft of this document was issued on October 24, 2019.
Saline, Silicone Gel, and Alternative Breast Implants Guidance for Industry and Food and Drug Administration Staff; Document issued on September 29, 2020. Document originally issued on November 17, 2006.
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- (Available at:)https://www.fda.gov/files/medical%20devices/published/Update-on-the-Safety-of-Silicone-Gel-Filled-Breast-Implants-%282011%29.pdf
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- (Available at:)https://www.fda.gov/news-events/press-announcements/fda-warns-about-illegal-use-injectable-silicone-body-contouring-and-associated-health-risks
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Tervaert: clinical discussion.
Available at: www.DeviceEvents.com | Madris@DeviceEvents.com.
- Foreign-body reaction to silicone gel in axillary lymph nodes after an augmentation mammaplasty.Plast Reconstr Surg. 1978; 62: 381-384
- Locally recurrent carcinoma after breast reconstruction.Ann Plast Surg. 1979; 3: 326-329
- Migration of silicone gel to axillary lymph nodes after prosthetic mammoplasty.Arch Pathol Lab Med. 1981; 105: 371-372
- [A case of stromal sarcoma of the breast occurring after augmentation mammaplasty].Gan No Rinsho. 1988; 34: 467-472
- Squamous cell carcinoma following breast augmentation.Ann Plast Surg. 1992; 29 ([discussion: 429-32]): 425-429
- Light and electron microscopic study of an invasive cribriform carcinoma with extensive microcalcification developing in a breast with silicone augmentation.Ultrastruct Pathol. 1994; 18: 519-523
- Suppressed natural killer cell activity in patients with silicone breast implants: reversal upon explantation.Toxicol Ind Health. 1994; 10: 149-154
- Follicular lymphoma adjacent to foreign body granulomatous inflammation and fibrosis surrounding silicone breast prosthesis.Am J Surg Pathol. 1995; 19: 712-717
- Cutaneous T-cell lymphoma in association with silicone breast implants.J Am Acad Dermatol. 1995; 32: 939-942
- [Fibrosarcoma after silicone breast augmentation: is there a connection?].Harefuah. 1998; 134 (424. Hebrew. PMID: 10909545): 339-341
- A case of inflammatory breast cancer following augmentation mammoplasty with silicone gel implants.Breast Cancer. 2000; 7: 71-74
- Lymphoplasmacytic lymphoma in a patient with leaking silicone implant.Haematologica. 2003; 88: 9
- Mortality rates among augmentation mammoplasty patients: an update.Epidemiology. 2006; 17: 162-169
- Invasive micropapillary carcinomas arising 42 years after augmentation mammoplasty: a case report and literature review.World J Surg Oncol. 2008; 6: 33
- Extranodal NK/T-cell lymphoma, nasal type, arising in association with saline breast implant: expanding the spectrum of breast implant-associated lymphomas.Am J Surg Pathol. 2012; 36: 1729-1734
- Recurrent invasive lobular carcinoma presenting as a ruptured breast implant.Radiol Oncol. 2012; 46: 23-27
- High-grade Angiosarcoma Associated with Ruptured Breast Implants.Plast Reconstr Surg Glob Open. 2013; 1: e11-e13
- Multiple bone metastases detected 10 years after mastectomy with silicone reconstruction for DCIS and contralateral augmentation.Clin Case Rep. 2013; 1: 26-29
- Lymphomas associated with breast implants: a review of the literature.Aesthetic Surg J. 2015; 35: 533-544
- Breast carcinoma originating from a silicone granuloma: a case report.World J Surg Oncol. 2015; 13: 72
- Breast Carcinoma in Augmented Breasts: MRI Findings; Victoria L. Mango1, Jennifer Kaplan2, Janice S. Sung2, Chaya S. Moskowitz3, D. David Dershaw2 and Elizabeth A. Morris2.(Read More: Available at:)
- Fine-needle aspiration detects primary neuroendocrine carcinoma of the breast in a patient with breast implants.Cyto J. 2015; 12: 1
- Primary Squamous Cell Carcinoma Arising From a Breast Implant Capsule: A Case Report and Review of the Literature.Aesthetic Surg J. 2018; 38: NP 97-NP 102
- Massive inflammatory reaction following the removal of a ruptured silicone implant masking the invasive breast cancer - case report and literature review.Pol Przegl Chir. 2016; 88: 41-47
- Breast Squamous Cell Carcinoma Following Breast Augmentation.Cureus. 2018; 10: e3405
- Aggressive breast fibromatosis following augmentation mastoplasty: a series of case reports.Ecancermedicalscience. 2018; 12: 833
- Breast cancer diagnosis and prognosis in women augmented with silicone gel-filled implants.Cancer. 1990; 66: 97-101
- (Available at:)https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
- (Available at:)https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources#:∼:text=As%20of%20June%202022%2C%20389%20suspected%2Fconfirmed%20U.S.%20cases,joint%20collaboration%20between%20ASPS%2C%20PSF%20and%20the%20FD
Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf4/P040046b.pdf.
- Mentor Saline SSED.(Available at:)
- Mcghan Saline SSED.(Available at:)
- Silicone gel filled breast implants and connective tissue disease: an overview.J Rheumatol. 1994; 21: 239-245
- Silicone-induced modulation of natural killer cell activity.Curr Top Microbiol Immunol. 1996; 210: 199-208
- Kappal: Low molecular weight silicones induce cell death in cultured cells.Immunology of Silicones. 1996; 210: 199-208
Vojdani A, Brautbar N, Campbell A. Immunologic and biologic markers for silicone. Toxicol Ind Health 1994;10(1-2):25–42.
- 2015; Volatile methyl siloxanes as potential hazardous air pollutants.Front Pharmacol. 2016; 7: 132
- ECRI: Medical Device Material Performance Study Siloxane Safety Profile; Prepared for U.S. FDA Center for Devices and Radiological Health, October 10, 2020.(Available at:)
Miro-Mur F, Hindié M, Kandhaya-Pillai R, et al. Medical-grade silicone induces release of proinflammatory cytokines in peripheral blood mononuclear cells without activating T cells. J Biomed Mater Res B Appl Biomater 2009;90(2):510–20.
Mater Res B Appl Biomater. 2009 Aug;90(2):510-520. https://doi.org/10.1002/jbm.b.31312. PMID: 19145631.
- Increased susceptibility to silicosis and TNF-alpha production in C57BL/6J mice.Am J Respir Crit Care Med. 1995; 152: 2144-2149
- Chronic biofilm infection in breast implants is associated with an increased T-cell lymphocytic infiltrate: implications for breast implant-associated lymphoma.Plast Reconstr Surg. 2015; 135: 319-329
- Silicone-Induced Granuloma of Breast Implant Capsule (SIGBIC): Histopathology and Radiological Correlation.J Immunol Res. 2018; 2018: 6784971
- breast implant-associated immunological disorders.J Immunol Res. 2022; 2022: 8536149
- Case report: evidence of migratory silicone particles arising from cohesive silicone breast implants.Front Glob Womens Health. 2022; 3: 730276
- Assessment of silicone particle migration among women undergoing removal or revision of silicone breast implants in the Netherlands.JAMA Netw Open. 2021; 4: e2125381
- Severe ASIA syndrome associated with lymph node, thoracic, and pulmonary silicone infiltration following breast implant rupture: experience with four cases.Lupus. 2015; 24: 463-468
- In vitro measurement of silicone bleed from breast implants.Plast Reconstr Surg. 1996; 97: 756-764
- Release of low molecular weight silicones and platinum from silicone breast implants.Anal Chem. 1997; 69: 4912-4916
- Silicone Gel Bleed on Breast Implants.Open Biomater J. 2011; 3: 14-17
- Gel bleed and rupture of silicone breast implants investigated by light-, electron microscopy and energy dispersive X-ray analysis of internal organs and nervous tissue.Clin Med Rev Case Rep. 2016; 3: 1-9
- Silicon assays in women with and without silicone gel breast implants–a review.Ann Plast Surg. 1999; 43: 324-330
- Do patients with silicone-gel breast implants have elevated levels of blood silicon compared with control patients?.Ann Plast Surg. 1995; 34: 343-347
- Hypergammaglobulinemia by prolonged adjuvanticity in man: disorders developed after augmentation mammoplasty.Ijishimpo. 1964; 22: 9-14
- Breast implant-related silicone granulomas: the literature and the litigation.Plast Reconstr Surg. 2002 Apr 15; 109 ([discussion: 1731-2]. PMID: 11932626.Yasuo Kumagai MD, Chiyuki Abe MD, Yuichi Shiokawa MD; Scleroderma After Cosmetic Surgery): 1724-1730
- A clinical and immunologic evaluation of women with silicone breast implants and symptoms of rheumatic disease.Ann Intern Med. 1993; 118: 929-936
- Borenstein siliconosis: a spectrum of illness.Semin Arthritis Rheum. 1994; 24 (Supplement 1): 1-7
Cohen Tervaert Discussion.
- A prospective analysis of patients undergoing silicone breast implant removal.Plast Reconstr Surg. 2000; 105: 2529-2537
Jamrógiewicz M, Szymkowska K, Krenczkowska D. Direct Human Contact with Siloxanes (Silicones) - Safety or Risk Part 1. Characteristics of Siloxanes (Silicones). Front Pharmacol 2016;7:132.
- Breast implant illness: scientific evidence of its existence.Expert Rev Clin Immunol. 2022; 18: 15-29
- Silicon analysis of breast and capsular tissue from patients with saline or silicone gel breast implants: II. Correlation with connective-tissue disease.Plast Reconstr Surg. 1998; 101: 1836-1841
- The objective effect of breast implant removal and capsulectomy on pulmonary function.Plastic and Reconstructive Surgery - Global Open. 2021; 9: e3636
Coroneos CJ, Selber JC, Offodile AC 2nd, Butler CE, Clemens MW. US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients. Ann Surg 2019;269(1):30–36.
- Silicone breast implants: immunotoxic and epidemiologic issues.Life Sci. 1995; 56: 1299-1310
- Serum silicon levels are elevated in women with silicone gel implants.Curr Top Microbiol Immunol. 1996; 210: 59-65
The authors have nothing to disclose.