BACKGROUND: The new generation of breast implants has an anatomic shape. These implants are made with a textured shell and filled with a cohesive silicone gel. Available since 1993 except in the United States, these implants are gaining in popularity for breast enlargement and reconstruction. This prospective, randomized, controlled, and blinded study was designed to compare mid- and long-term results with the use of cohesive gel-filled implants from two different manufacturers: Style 410 of the McGhan brand (MG) made by Allergan and Vertex made by Eurosilicone (ES). METHODS: From May 1997 to May 1999, 80 women underwent breast augmentation: 40 with Style 410 implants (MG) and 40 with Vertex implants (ES). All surgeries were performed by the same surgeon (I.N.). Another physician (G.J.) interviewed and examined 64 of these women (80%) 4 to 6 years (median, 5 years) after implantation. In addition, 10 patients responded to the same questionnaire and were interviewed by phone, bringing the follow-up rate to 92.5%. RESULTS:Overall, satisfaction was high, with 98.6% of the patients evaluated after 4 to 6 years "very satisfied" or "satisfied" with the result in general. Approximately 20% of the patients who responded judged their breasts to be firmer than desirable. Breast augmentation classification (BAC) was used to grade the breast firmness of the 64 patients examined by G. J. At examination, 24% of patients had soft breasts, 53% had slightly firm breasts, and 23% had moderately firm breasts. That last category also was classified as capsular contracture. No patient was graded as having very hard breasts (BAC 4). Skin sensitivity of the breast adjacent to the incision was altered for 25% of the patients. The implant rotated in four patients (5%). Breast firmness, implant palpability, nipple sensitivity, and skin sensitivity were further analyzed by implant location (submuscular vs subglandular) and implant size (volume). Frequency of the breast asymmetries and the impact of augmentation on asymmetric breasts also was studied. All these analyses were performed with the entire pool of examined patients who answered the follow-up questionnaire. Data also were analyzed by distinguishing between results of the two each implant manufacturers. The results showed no difference between the Eurosilicone and McGhan implants except for the self-evaluation of "breast consistency" by the patient. A higher percentage of patients with the Vertex implants than with the McGhan implants reported that their breast was "firmer than desired." CONCLUSIONS: Breast augmentation with anatomic, textured, cohesive silicone gel-filled implants is a reliable procedure with consistently good results. The results also show that candidates for breast enlargement should be informed that their implanted breast may feel firmer than their natural breasts. They also may experience reduced sensation of their nipple or breast skin.
RCT Entities:
BACKGROUND: The new generation of breast implants has an anatomic shape. These implants are made with a textured shell and filled with a cohesive silicone gel. Available since 1993 except in the United States, these implants are gaining in popularity for breast enlargement and reconstruction. This prospective, randomized, controlled, and blinded study was designed to compare mid- and long-term results with the use of cohesive gel-filled implants from two different manufacturers: Style 410 of the McGhan brand (MG) made by Allergan and Vertex made by Eurosilicone (ES). METHODS: From May 1997 to May 1999, 80 women underwent breast augmentation: 40 with Style 410 implants (MG) and 40 with Vertex implants (ES). All surgeries were performed by the same surgeon (I.N.). Another physician (G.J.) interviewed and examined 64 of these women (80%) 4 to 6 years (median, 5 years) after implantation. In addition, 10 patients responded to the same questionnaire and were interviewed by phone, bringing the follow-up rate to 92.5%. RESULTS: Overall, satisfaction was high, with 98.6% of the patients evaluated after 4 to 6 years "very satisfied" or "satisfied" with the result in general. Approximately 20% of the patients who responded judged their breasts to be firmer than desirable. Breast augmentation classification (BAC) was used to grade the breast firmness of the 64 patients examined by G. J. At examination, 24% of patients had soft breasts, 53% had slightly firm breasts, and 23% had moderately firm breasts. That last category also was classified as capsular contracture. No patient was graded as having very hard breasts (BAC 4). Skin sensitivity of the breast adjacent to the incision was altered for 25% of the patients. The implant rotated in four patients (5%). Breast firmness, implant palpability, nipple sensitivity, and skin sensitivity were further analyzed by implant location (submuscular vs subglandular) and implant size (volume). Frequency of the breast asymmetries and the impact of augmentation on asymmetric breasts also was studied. All these analyses were performed with the entire pool of examined patients who answered the follow-up questionnaire. Data also were analyzed by distinguishing between results of the two each implant manufacturers. The results showed no difference between the Eurosilicone and McGhan implants except for the self-evaluation of "breast consistency" by the patient. A higher percentage of patients with the Vertex implants than with the McGhan implants reported that their breast was "firmer than desired." CONCLUSIONS: Breast augmentation with anatomic, textured, cohesive silicone gel-filled implants is a reliable procedure with consistently good results. The results also show that candidates for breast enlargement should be informed that their implanted breast may feel firmer than their natural breasts. They also may experience reduced sensation of their nipple or breast skin.
Authors: Louis Poppler; Justin Cohen; Utku Can Dolen; Andrew E Schriefer; Marissa M Tenenbaum; Corey Deeken; Richard A Chole; Terence M Myckatyn Journal: Aesthet Surg J Date: 2015-08 Impact factor: 4.283