Ideal Implant Structured Breast Implants: Core Study Results through 10 Years.

BACKGROUND: The Ideal Implant structured breast implant uses different technology than unstructured saline or silicone gel implants, making it a third type of implant. U.S. Food and Drug Administration (FDA) and Health Canada granted approval in November of 2014. This saline-filled implant has an internal structure consisting of a series of nested shells that support the upper pole when upright and control movement of the saline to provide a natural feel. Because women can look in the mirror to know their implants are intact, they have peace of mind. In contrast, most women are concerned about silicone gel implant ruptures, which are silent and require FDA-recommended magnetic resonance imaging or ultrasound scans for detection. METHODS: This U.S. trial enrolled 502 women: 399 for primary and 103 for revision augmentation. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 426 (84.9%) completed 10-year follow-up visits, a higher percentage than all other FDA breast implant trials. RESULTS: Through 10 years of follow-up, surgeon satisfaction was 94.8% for primary and 87.4% for revision augmentation; and patient satisfaction was 92.7% for primary and 82.3% for revision augmentation. Cumulative Kaplan-Meier risk rates for two major adverse events were lower than in the silicone gel implant trials: Baker class III and IV capsular contracture was 6.6% for primary and 11.5% for revision augmentation; and rupture/deflation was 3.7% for primary and 4.7% for revision augmentation. CONCLUSION: Ten-year results from 426 women show the Ideal Implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years.

BACKGROUND: The structured breast implant uses different technology than saline or silicone gel implants, making it a third type of implant. The U.S. Food and Drug Administration and Health Canada granted approval in November of 2014. This implant is filled with saline but has an internal structure consisting of a series of nested shells that support the upper pole when upright and control fluid movement. It combines certain key features and benefits of saline and silicone gel implants. As with saline, the filler is only saline, which women like for peace of mind in case of rupture/deflation. As with silicone gel, it has a natural feel, but without the risk of silent rupture and U.S. Food and Drug Administration-recommended magnetic resonance imaging scans-women can simply look in the mirror and know their implants are intact. METHODS: This U.S. trial enrolled 502 women: 399 primary augmentations and 103 replacements of existing augmentation implants. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 438 (87.3 percent) completed 6-year follow-up visits, a higher percentage than other Core breast implant trials. RESULTS: At 6 years, patient satisfaction was 89.7 percent for primary and 91.6 percent for replacement augmentations; surgeon satisfaction was 92.6 percent for primary and 94.0 percent for replacement augmentation. Kaplan-Meier adverse event rates were as follows: Baker grade III and IV capsular contracture, 5.7 percent for primary and 11.5 percent for replacement augmentation; and rupture/deflation, 1.8 percent for primary and 4.7 percent for replacement augmentation. CONCLUSION: Six-year results from 438 women show that the structured breast implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Oral administration of L-arginine decreases necrosis of the epigastric skin flap in the rat.

BACKGROUND: We investigated the effect of prolonged oral arginine administration on tissue necrosis and perfusion in the rat skin flap. METHODS: Twenty-five Sprague-Dawley rats had an 8 x 8 - cm epigastric skin flap elevated and were divided in 2 groups, l-Arginine and Control, which respectively received oral 6% l-arginine solution or water for 8 days postoperatively. On postoperative day 8, area of flap necrosis was measured, and the animals were perfused systemically with 15-microm colored fluorescent microspheres before (blue) and after (yellow-green) ligation of the flap pedicle. RESULTS: l-Arginine reduced total flap necrosis (6.53 +/- 3.76 cm versus 11.91 +/- 4.12 cm; P < 0.01). After pedicle ligation, total flap perfusion remained unchanged in Control but diminished in the l-Arginine group (Control: 0.47 +/- 0.23 and 0.42 +/- 0.06; P = nonsignificant versus l-Arginine: 0.58 +/- 0.29 and 0.27 +/- 0.19; P < 0.01). Serum levels of l-arginine were higher in the l-arginine-treated animals (504 +/- 154 versus 152 +/- 34 micromol/l; P < 0.0001). CONCLUSIONS: Postoperative oral administration of l-arginine decreased flap necrosis in the rat epigastric skin flap. Flap perfusion following oral l-arginine was more dependent on the main vascular pedicle.

A unique combination of infrared and microwave radiation accelerates wound healing.

Light or electromagnetic radiation has been reported to enhance wound healing. The use of selected spectra, including infrared and microwave, has been described; however, no studies to date have examined the potential benefit of combining these spectra. In this study, a device that emits electromagnetic radiation across both the infrared and microwave ranges was used. To test the effects of this unique electromagnetic radiation spectrum on wound healing, two clinically relevant wound-healing models (i.e., tensile strength of simple incisions and survival of McFarlane flaps) were selected. After the creation of a simple full-thickness incision (n = 35 rats) or a caudally based McFarlane flap (n = 33 rats), animals were randomly assigned to one of three treatment groups: untreated control, infrared, or combined electromagnetic radiation. Treatment was administered for 30 minutes, twice daily for 18 days in animals with simple incisions, and 15 days in animals with McFarlane flaps. The wound area or flap was harvested and analyzed, blinded to the treatment regimens. A p value of less than 0.05 obtained by analysis of variance was considered to be statistically significant. Animals receiving combined electromagnetic radiation demonstrated increased tensile strength (2.62 N/mm2) compared with animals receiving infrared radiation (2.36 N/mm2) or untreated controls (1.73 N/mm2, p < 0.001). Animals with McFarlane flaps receiving combined electromagnetic radiation had increased flap survival (78.0 percent) compared with animals receiving infrared radiation (69.7 percent) and untreated controls (63.1 percent, p < 0.01). Thus, combined electromagnetic radiation provided a distinct advantage in wound healing that might augment current treatment regimens.

Sentinel lymph node biopsy in the augmented breast: role of the transaxillary subpectoral approach.

Given the use of sentinel lymph node biopsy for breast cancer staging, some plastic surgeons may be hesitant to offer patients a transaxillary approach to augmentation for fear of disrupting the lymphatic drainage of the breast. Dissection within the axilla theoretically compromises the normal drainage of the breast tissue to the axillary lymph node basin, a critical element in the procedure of sentinel lymph node mapping. We present a case report in which successful sentinel lymph node biopsy was performed after transaxillary subpectoral augmentation mammaplasty. Remaining high and anterior in the axilla within the subcutaneous plane is crucial in minimizing any compromise of normal lymphatic drainage. In addition, it is generally agreed that subpectoral placement of the implant generates less distortion in the mammographic evaluation of the breast than does a subglandular implant. As a result, the transaxillary subpectoral method of augmentation may be one of the most amenable techniques with regard to screening and diagnosis of breast cancer. (Aesthetic Surg J 2003;23:184-187.).

Necrotizing fasciitis: a fourteen-year retrospective study of 163 consecutive patients.

This review was prompted by continued public and professional interest of necrotizing fasciitis as well as worldwide increases in the incidence of streptococcal invasive infections. Our objective was to outline the clinical course of necrotizing fasciitis and delineate factors relating to mortality among 163 diagnosed patients. Over 14 years patients diagnosed with necrotizing fasciitis were reviewed for patient history, comorbid conditions, and progression of clinical course. A logistic regression model was used to identify factors increasing mortality risk among necrotizing fasciitis patients. Nearly 17 per cent of the patients showed no identifiable antecedent trauma. Seventy-one per cent of tissue culture-positive patients (145) had multibacterial infections. Although no streptococcal species were recovered from one-third of these culture-positive patients there was an increase in mortality noted with beta-Streptococcus infections. Ninety-six per cent of the patient deaths were correlated with variables organized into the following categories: 1) patient history (intravenous drug use and age <1 or >60 years), 2) comorbid conditions (cancer, renal disease, and congestive heart failure), 3) characteristics of clinical course (trunk involvement, positive blood cultures, peripheral vascular disease, and positive cultures for beta-streptococcus or anaerobic bacteria), and 4) quantitative timeline of clinical course (time: injury to diagnosis, diagnosis to treatment). Mortality is correlated to patient history, comorbid conditions, and progression of clinical course. Necrotizing fasciitis can occur idiopathically and is generally a polymicrobial infection that sometimes occurs in the absence of streptococci. Clearly the mortality and morbidity associated with necrotizing fasciitis can be decreased with clinical awareness, early diagnosis, adequate surgical debridement, and intensive supportive care.