Cohesive Gel Breast Implants Research Articles

Results of the Postmarket Clinical Study of the Sientra 207 Highly Cohesive Gel Breast Implants in Primary and Revision Augmentation.

Board-certified plastic surgeons utilizing the Sientra 207 Highly Cohesive Gel breast implants provided their initial satisfaction with usage and postoperative results on primary and revision augmentation patients, and study participants provided their satisfaction with surgical result. Up to 15 participating investigators at institutional review board-approved sites enrolled up to 180 women who received Sientra 207 implants for primary augmentation or revision augmentation procedures. Investigator and participant assessments were performed preoperatively and postoperatively at 3, 6, and 12 months. All participating surgeons found the implants to be easy or very easy to implant, and 92 percentage reported satisfaction with surgical results. Patients receiving these implants reported similarly high rates of satisfaction (94%). With this combination of high satisfaction and low complication rates, the Sientra 207 silicone breast implants now provide a welcome addition to plastic surgeons' breast implant options.

Is periareolar incision a suitable option for breast surgery? A mathematical comparison between periareolar and inframammary fold approaches

Is periareolar incision a suitable option for breast surgery? A mathematical comparison between periareolar and inframammary fold approaches Alessandro Borgognone,1 Giulio Gherardini,2 Luigi Gliosci,1 Daniele D’Andria2 1ASL ROMA 2, Division of Burn and Plastic Surgery, Sant’Eugenio Hospital – CTO Hospital, 2Private Practice, Rome, Italy Background: Several incisions have been proposed for the insertion of breast implants, but it is still debated which is the most conservative for the integrity of the prosthesis. There are no reports comparing periareolar and inframammary incisions on a mathematical basis. This study analyzed the efficacy of the two incisions through a detailed comparison based on increasing incision lengths to enable a more directed clinical choice.Materials and methods: An 8-cm scale was plotted, representing either the linear section of an inframammary incision or the diameter of an ideal circumference; the corresponding hemi-circumference was calculated, and the advantage in length of the curvilinear section was determined.Results: The data analysis confirmed a statistically significant increase of 36% in length when a curvilinear section was compared to an inframammary fold incision of the same length as the diameter of the related curvilinear section.Conclusion: A periareolar incision may be a more effective technique to reduce the mechanical stress over cohesive gel breast implants during its insertion. Keywords: periareolar incision, inframammary incision, comparison of mammary incisions, breast implant incisions

Management of Tuberous Breast Deformity with Anatomic Cohesive Silicone Gel Breast Implants

Tuberous breast deformity is a rare congenital condition that often requires surgical correction. Numerous surgical techniques have been described, reflecting the reconstructive challenge of this deformity. The anatomic cohesive gel breast implant is a powerful tool in both aesthetic and reconstructive breast surgery. In the authors' experience, its use in treating tuberous breast deformity has provided the opportunity for a single-stage approach, with very good results. The senior author has managed more than 50 cases of single-stage reconstruction for tuberous breast deformity using anatomic cohesive gel breast implants. His surgical technique is described with suggestions for achieving optimal results. Representative case examples are provided. The anatomic cohesive silicone gel breast implant is an excellent device for treating tuberous breast deformity. It often can be used as a single-stage correction of the deformity with very good results. The authors strongly advocate consideration of its use in tuberous breast deformity reconstruction.

Prospective Study Comparing Two Brands of Cohesive Gel Breast Implants with Anatomic Shape: 5-Year Follow-Up Evaluation

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). 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%. 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." 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.

Discussion

Background: Cohesive silicone gel breast implants are composed of a textured silicone elastomer shell and are filled with cohesive silicone gel. Cohesive gel is formed by increasing the number of crosslinks between gel molecules, which results in an implant that has better retention of shape and is less likely to fold or collapse, especially in the upper pole. Methods: The initial 150 consecutive patients who received cohesive gel breast implants by the senior author (Brown) were included in the study. A retrospective chart review was carried out to analyze patient demographics, diagnosis, indication for cohesive gel selection, procedure performed, implant selected, and complications. All implants were manufactured by Inamed Aesthetics and were either style 410, CML, or CMH. Results: One woman underwent unilateral augmentation for breast asymmetry and 117 women underwent bilateral breast augmentation. Of the 235 implants used, all were model 410 anatomical implants, with the majority being MM, MF, FM, or FF styles. Complications occurred in four of 118 patients (3.4 percent). There was one immediate postoperative hematoma, two cases of unilateral Baker II contracture, and one case of asymmetry related to excessive lowering of an inframammary fold. There were no cases of rotation, malposition, infection, rippling, or loss of implant integrity. Thirty-two women underwent breast reconstruction with cohesive gel implants. A total of 50 implants were used in the 32 patients (27 style 410, 19 style CML, and four style CMH). Complications occurred in six of 32 patients (18.8 percent), although five of the six were minor and only one of 32 patients (3.1 percent) required a secondary procedure. There were two seromas, three capsular contractures, and one implant exposure following a skin-sparing mastectomy. Conclusions: Cohesive gel implants have the potential for providing a natural breast shape, minimizing the risk of postoperative rippling, and providing a greater degree of safety should the implant lose its integrity. The wide variety of implant shapes and sizes allows for great flexibility in reconstructive surgery, in cases of breast asymmetry, and in primary breast augmentation. Results in our initial 150 patients have been excellent, with a high degree of patient satisfaction, excellent aesthetic outcomes, and very few implant-related complications. Cohesive gel implants are likely to play an important role in aesthetic and reconstructive breast surgery when silicone gel implants are reintroduced into the North American market.

Cohesive Silicone Gel Breast Implants in Aesthetic and Reconstructive Breast Surgery

Cohesive silicone gel breast implants are composed of a textured silicone elastomer shell and are filled with cohesive silicone gel. Cohesive gel is formed by increasing the number of cross-links between gel molecules, which results in an implant that has better retention of shape and is less likely to fold or collapse, especially in the upper pole. The initial 150 consecutive patients who received cohesive gel breast implants by the senior author (Brown) were included in the study. A retrospective chart review was carried out to analyze patient demographics, diagnosis, indication for cohesive gel selection, procedure performed, implant selected, and complications. All implants were manufactured by Inamed Aesthetics and were either style 410, CML, or CMH. One woman underwent unilateral augmentation for breast asymmetry and 117 women underwent bilateral breast augmentation. Of the 235 implants used, all were model 410 anatomical implants, with the majority being MM, MF, FM, or FF styles. Complications occurred in four of 118 patients (3.4 percent). There was one immediate postoperative hematoma, two cases of unilateral Baker II contracture, and one case of asymmetry related to excessive lowering of an inframammary fold. There were no cases of rotation, malposition, infection, rippling, or loss of implant integrity. Thirty-two women underwent breast reconstruction with cohesive gel implants. A total of 50 implants were used in the 32 patients (27 style 410, 19 style CML, and four style CMH). Complications occurred in six of 32 patients (18.8 percent), although five of the six were minor and only one of 32 patients (3.1 percent) required a secondary procedure. There were two seromas, three capsular contractures, and one implant exposure following a skin-sparing mastectomy. Cohesive gel implants have the potential for providing a natural breast shape, minimizing the risk of postoperative rippling, and providing a greater degree of safety should the implant lose its integrity. The wide variety of implant shapes and sizes allows for great flexibility in reconstructive surgery, in cases of breast asymmetry, and in primary breast augmentation. Results in our initial 150 patients have been excellent, with a high degree of patient satisfaction, excellent aesthetic outcomes, and very few implant-related complications. Cohesive gel implants are likely to play an important role in aesthetic and reconstructive breast surgery when silicone gel implants are reintroduced into the North American market.