Purpose:  The purpose of this study is to introduce our experience of treating patients who developed complications after injection of large amounts of paraffin into the breasts for augmentation, and to propose a classification according to the degree of the complication.

Material and Methods: From May 1, 1992 to December 31, 2001 we experienced 18 patients suffering from complications after paraffin injections into the breasts.  The classification of the disease in 3 stages was based on the development of symptoms and signs related the injected paraffin.  We managed the patients according to the 3 stages. Patients with acute inflammatory reaction with mild swelling, warmness on the breasts were assigned to Grade I, and were treated conservatively. Palpable masses with hardness, chronic pain and tenderness, chronic edema, disfigurement of breast shape, induration of skin, and psychologic discomfort were classified as Grade II.  These patients were managed with partial or total subcutaneous mastectomy. Ulceration or necrosis of the breast, malignant change, and adjuvant disease were regarded as Grade III. Treatment of this group of patients consisted of total resection of breasts or modified radical mastectomy.  All patients who underwent surgical removal of breasts were treated with immediate reconstruction with free TRAM flap or camouflage procedure.

Results: 9 patients showed Grade I disease and were treated with medication including steroids and anti-inflammatory drugs. 5 patients underwent surgical resection of the indurated masses or subcutaneous mastectomy according to Grade II. 4 patients with Grade III underwent modified radical mastectomy. One of these patients had ductal cell carcinoma in the specimen.  The time period of symptom development after paraffin injection reached from 3 years to 15 years with a great individual variation.

Conclusion:  Our classification can be applied to any foreign body reaction in the tissue (including paraffin or silicone, etc).  Particularly paraffin developed severe, irreversible complications in the breasts with time.  We believe that a strategic management based on the classification is necessary for the breast preservation.

Fig.1.(Upper, Left) Grade III paraffinoma complication shows hard induration, ulceration and necrosis of skin.  Multiple rashes on the chest are also noted.

Fig. 2.(Upper, Right) The whole lesion of hard breast was resected.

Fig. 3. (Lower, Left) Bilateral free TRAM flaps were harvested for the immediate reconstruction of breasts.

Fig. 4. (Lower, Left) Postoperative view of bilateral breast reconstruction with TRAM flaps.