Granulomatous Inflammatory Reaction in Breast Silicone Implants

Transcription

1 June 2014, Vol. 8, No. 6, pp Journal of Life Sciences, ISSN , USA D DAVID PUBLISHING Granulomatous Inflammatory Reaction in Breast Silicone Implants Tammaro A. 1, Giulianelli V. 1, Narcisi A. 1, Abruzzese C. 1, Cortesi G. 1, Parisella F.R. 2, Persechino S. 1 and Grippaudo F.R UOC of Dermatology University, Sapienza University of Rome, Via di Grottarossa 1039, 00189, Italy 2. Premedical School of Medicine University of Towson Maryland, 8000 York Road Towson, MD , USA 3. Plastic Surgery Unit, NESMOS Dept, Sapienza University of Rome, Via di Grottarossa 1039, 00189, Italy Received: August 21, 2013 / Accepted: November 25, 2013 / Published: June 30, Abstract: Introduction: breast implants have been used to correct the size and the form of a breast in post-mastectomy breast reconstruction, for correcting congenital defects and deformities or for purely aesthetic breast augmentation. Silicone breast implants were introduced in the 1960s. They are non without complications, like rupture is or silicone gel bleeding. Materials and methods: the authors present the case of 50 patients, aged 45-55, who presented to our attention after 15 (+ 5) years of the application of silicone breast implant for the appearance of lumps under the skin in the armpit area. These were palpable, painless except on palpation. The patients reported burning in the affected area, but no other symptoms. Results: considering the presence in each of them of silicone implants, and assuming a possible allergic basis, the authors performed a patch test series SIDAPA produced by F.I.R.M.A Spa, Firenze, ultrasound and MR and blood tests. In all patients the allergy test (patch test) were negative, ultrasound and MR have shown that no hearing was damaged or broken. Blood test showed no abnormalities. Discussion: comparing the authors study with other similar works in the literature, they noted that the reported cases of hypersensitivity type 4 silicone prosthesis was not only initially accompanied by specific symptoms such as urticaria and blistering, but mostly it was found to be a net positive patch test. The absence of urticaria, the low values of IgE and total negativity of patch test confirmed the purely inflammatory nature of the lesions in our patients. Key words: Silicone breast implant; inflammation; siliconoma; patch test. 1. Introduction Breast implants have been used, since the late nineteenth century, to correct the size and the form of a breast in post-mastectomy breast reconstruction, for correcting congenital defects and deformities or for purely aesthetic breast augmentation. Silicone breast implants were introduced in the 1960s and since then many different devices were introduced in the market, differing in outer silicone shell manufacture (single lumen, double lumen, smooth or textured) and in inner silicone gel properties [1]. Corresponding author: Tammaro Antonella, Ph.D., research fields: Dermatology and Allergology. [email protected]. Silicone implants procedure are non without complications, and among them, breast implant rupture is reported with a frequency up to 65% at 10 years. Silicone gel bleeding has also been reported with an incidence of 7.2 % [2]. After a breast implant rupture, silicone can migrate out of the perimplant capsule and has been reported in the regional lymphnodes but as well within the breast tissue, in the contralateral lymphnodes or in other body tissues as well [3]. Patients with ruptured implants often complain of rushes, pruritus, fatigue and immunological pathologies. The aim of this study is to ascertain a possible role of allergy in patients with breast implants ruptured or not.

2 Granulomatous Inflammatory Reaction in Breast Silicone Implants 559 Although the aesthetic results were initially satisfactory, there had been subsequent evidence of how this type of prosthesis would lead to a series of drawbacks which require surgical intervention. Literature reports both localized and systemic complications, from ruptured or intact implants [4]. 2. Materials and Methods It presented the case of 50 patients, aged 45-55, who presented to our attention after 15 (+ 5) years of the application of silicone breast implant for the appearance of lumps under the skin in the armpit area. These were palpable, painless except on palpation. The patients reported burning in the affected area, but no other symptoms. Of the 50 patients, 30 had performed a breast augmentation, 20 had undergone breast reconstruction. None of them followed a drug therapy. The patients that were not taken into consideration in this study had applied silicone prosthesis breast but not present any symptoms. This group of patients (50 women between 40 and 55 years) was used as a control group. Considering the presence in each of them of silicone implants, and assuming a possible allergic basis, we performed a patch test series SIDAPA produced by F.I.R.M.A Spa, Firenze. The test consists in applying on the back of the patient (by a single operator, Dott. A. Tammaro) of patches containing the following haptens: potassium dichromate; Rosin; epoxy resin; formaldeidica resin; euxil 400; neomycin sulfate; fragrance mix; nickel sulphate; mercaptobenzotiaziolo; paraphenylendiamine; cobalt chloride; balsam of peru; thiuram mix; benzocaine; lanolin alcohols; parabens; Vaseline; scattered yellow; scattered blue; Hydroquinone. The patient was asked not to wash your back, and did not take cortisone and antihistamines by mouth. Patients came back after 48 h at our clinic: the operator who applied the patches removes the patches, making a first reading. The patient returned after 12 h for reading at 72 h. The test is positive if at the locations of contact with haptens any signs such as erythema (+ positive), erythema + vesicles (+ + positive), erythema + vesicles + edema (+ + + positive). All Patch test resulted negative (absence of all signs). To make the research more scrupulous, we subsequently also applied additional haptens, such as latex and silicone oil (produced by F.I.R.M.A Spa, Firenze), the result of which was negative. It assumed breakage of the implant, and we then subjected the patients to ultrasound and magnetic resonance skin. 3. Results In all patients the allergy test (patch test) was negative. The ultrasound and MR have shown that no hearing was damaged or broken. Blood tests showed no abnormalities: blood count was normal, as well as the white blood cell count. The prist was not increased, such as C-reactive protein, the Ves and Tas. There was no evidence of infections. In each patient, we excluded any possible cause allergic or infective, thus leading to the conclusion that the nodules were determined by a granulomatous inflammatory reaction. 4. Discussion Silica is actually used in medical practice in various form: solid, like in prosthesis or tubes, liquid, such as soft tissue filler, and gel, like implant breast [5]. Obviously medical silicone is a particular and specific type of silicone: it is called also siloxanes, and in structures like breast implant we find a specific form, carachterized by silicon element with oxygen and organic methyl groups (CH3) attached directly to silicon (the most common is for example polydimethylsiloxane or PDMS). In every case it is a polymer carbon-based.

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4 Granulomatous Inflammatory Reaction in Breast Silicone Implants 561 Until the use of highly cohesive silicone gel matrix implants from the 1990 s, implants were filled with silicone gel with the presence of silicone oil, that could escape from the structure in form of holes or tears (the so called bleeding) [6] also in case of intact silicone envelope [7]. There are more problems in case of massive breakages, with the loss and the escape of most of the content in silicon, and subsequent migration of this in the areas surrounding the prosthesis. There are various causes of implant rupture, but the most common are compression from closed capsulotomy, mammography or trauma [8]. In these cases, the system and specifically the silicone leaked, acts as a foreign body to which the body responds with an inflammatory reaction. It's widely reported in the literature as the silicone particles follow a systemic hematogen or lymphatic pathway, such as to explain the presence of so-called granulomas from silicone or siliconomi even in areas away from the site of the prosthesis [9]. Silicone granuloma (SG) or siliconoma was described for the first time in 1964 by Winer et al., and it was correlated with the injection of free silicone for breast augmentation. Subsequently the presence of SG was also connected to the rupture of breast implants silicone based (1980) [4]. Especially in the case of less viscous silicone gel, which passes more easily through the tissues, the SG is an attempt by the organism to remove leaked silicone [10]: it acts as an adjuvant and activates the immune system with the production of autoantibodies. The activation of the immune system is detectable by the presence of antibodies to silicone and autoantibodies in the serum of patients [11]. On histologic examination, a siliconoma presents multinucleated giant cells and histiocytes carahterized by foamy cytoplasm due to the presence of silicone particles, with vacuoles there are free in the stroma. These particles are refractive to decreased incident light and appear as birefringent foreign bodies under polarised light [7]. The presence of granulomatous reaction of inflammatory base can be frequently associated, such in the case of our patients, with the ipsilateral axillary region, but have also been reported cases of contralateral lymphadenopathy [8]. Based on the personal history and the patch test results, we made diagnosis of inflammatory lymphadenopathy, with the presence of granulomatous processes or siliconomi. Comparing our study with other similar works in the literature, we noted that the reported cases of hypersensitivity type 4 silicone prosthesis was not only initially accompanied by specific symptoms such as urticaria and blistering, but mostly it was found to be a net positive patch test [12]. The absence of urticaria, the low values of IgE and total negativity of patch test confirmed the purely inflammatory nature of the lesions in our patients. References [1] Johnson, M. 2013, Breast implants: History, safety, and imaging. Radiol Technol 84 (5): 439. [2] Brown, S. L., Parmentier, C. M., Woo, E. K., Vishnuvajjala, R. L., Headrick, M. L. 1998, Silicone gel breast implant adverse event reports to the Food and Drug Administration, Public Health Rep. 113 (6): [3] Dragoumis, D. M., Assimaki, A. S., Vrizas, T. I., and Tsiftsoglou, A. P. 2010, Axillary silicone lymphadenopathy secondary to augmentation mammaplasty. Indian J. Plast Surg. 43 (2): [4] El-Charnoubi, W.A., Foged Henriksen, T., Joergen Elberg, J., Cutaneous silicone granuloma mimicking breast cancer after ruptured breast implant, Case Rep Dermatol Med. 2011; 2011: doi: /2011/ (Epub Jan. 26, 2012). [5] Rubio-Flores, C., Martín-Díaz, M. A., González-Beato, M. J., Díaz-Díaz, R. M. 2005, Granuloma from liquid silicone. Actas. Dermosifiliog. r 96 (9): [6] Brown S. L., Silverman B. G., Berg W. A. 1997, Rupture of silicone gel breast implants: Causes, sequela, and diagnosis. Lancet 350: [7] Ozlem Gundeslioglu, A., Hakverdi S., Erdem, O., Cigdem Ozen, E., Inan, I., Emlik, D. 2013, Axillary lipogranuloma mimicking carcinoma metastasis after

5 562 Granulomatous Inflammatory Reaction in Breast Silicone Implants silicone breast implant rupture: A case report, Journal of Plastic. Reconstructive & Aesthetic Surgery 66: [8] Kaufman, G. J., Sakr, R. A., Inguenault, C., Sarfati, I., Nos, C., Clough, K. B., Silicone migration to the contralateral axillary lymph nodes and breast after highly cohesivesilicon gel implant failure: A case report, Cases J.; 2:6420. doi: / (Mar. 10, 2009). [9] Dragu, A., Theegarten, D., Bach, A. D., Polykandriotis, E., Arkudas, A., Kneser, U., Horch, R. E., Ingianni, G. 2009, Intrapulmonary and cutaneous siliconomas after silent silicone breast implant failure. Breast J. 15 (5): [10] Grubstein, A., Cohen, M., Steinmetz, A., Cohen, D. 2011, Siliconomas mimicking cancer. Clin. Imaging 35 (3): [11] Hortolam, J. G., Carvalho, J. F., Appenzeller, S. 2013, Connective tissue diseases following silicone breast implantation: Where do we stand? Clinics (Sao Paulo) 68 (3): 281. [12] Dargan, D., McGoldrick, C., Khan, K. J., Type, I. V. 2012, hypersensitivity to a textured silicone breast implant. Plast Reconstr Aesthet Surg. 65 (7):