MemoryGel Breast Implants: Final Safety and Efficacy Results after 10 Years of Follow-Up.

BACKGROUND: Mentor MemoryGel Breast Implants were approved by the U.S. Food and Drug Administration in November of 2006. Patients in the Core clinical study supporting this approval were followed for 10 years. METHODS: This prospective, multicenter, clinical study included primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction patients implanted with smooth or Siltex Texture MemoryGel Implants. Incidence, severity, and method of resolution for all postoperative complications were assessed on per-patient and per-implant bases. The primary effectiveness endpoints were overall mean change in chest circumference and bra cup size following the implantation procedure. RESULTS: Primary augmentation (n = 552), revision augmentation (n = 145), primary reconstruction (n = 251), and revision reconstruction (n = 60) patients were enrolled in the study. Kaplan-Meier estimated 10-year cumulative incidence rates for key complications at the subject level for Baker grade III/IV capsular contracture were as follows: primary augmentation, 12.1 percent; revision augmentation, 24.4 percent; primary reconstruction, 20.5 percent; and revision reconstruction, 36.9 percent. For infection, rates were as follows: primary augmentation, 1.6 percent; revision augmentation, 1.4 percent; primary reconstruction, 6.2 percent; and revision reconstruction, 0 percent. For explantation with or without replacement, rates were as follows: primary augmentation, 11.6 percent; revision augmentation, 24.1 percent; primary reconstruction, 33.4 percent; and revision reconstruction; 37.8 percent. For rupture, rates were as follows: primary augmentation, 24.2 percent; revision augmentation, 23.7 percent; primary reconstruction, 32.7 percent; and revision reconstruction, 38.7 percent. For any reoperation, rates were as follows: primary augmentation, 25.5 percent; revision augmentation, 43.6 percent; primary reconstruction, 49.0 percent; and revision reconstruction, 50.7 percent. CONCLUSION: The results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Implant Testing and the "Strain Energy" Concept.

Benchtop performance test methodologies differ between manufacturers as regulatory agencies often leave the interpretation of testing standards up to manufacturer discretion, resulting in an inability to directly compare implants across manufacturers. Furthermore, traditional benchtop test methodologies focus on mechanical performance standards to address objective endpoints such as shell strength. However, other more difficult to define clinical performance requirements such as softness and natural feel are often difficult to measure via these methods. This review aims to discuss the evolution of breast implant testing standards, discuss the discrepancies in benchtop characterizations of implants, and highlight one manufacturer's novel approach to utilizing benchtop methodologies to quantify previously subjective endpoints such as firmness and natural feel and define their clinical relevance.

Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years.

BACKGROUND: Contour Profile Gel/MemoryShape breast implants consist of a textured silicone elastomer shell filled with silicone gel. The objective of this clinical study was to assess the safety and effectiveness of Contour Profile Gel/MemoryShape breast implants in women who were undergoing primary breast augmentation, primary breast reconstruction, or revision surgery (revision-augmentation or revision-reconstruction). METHODS: This was a prospective, open-label, multicenter clinical study involving Contour Profile Gel/MemoryShape breast implants in 955 female subjects, including 572 primary augmentation, 124 revision-augmentation, 190 primary reconstruction, and 69 revision-reconstruction subjects. Safety was assessed based on the incidence, severity, and method of resolution of all complications. Endpoints were examined on both a per-subject and a per-implant basis. RESULTS: For the primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction cohorts, the Kaplan-Meier estimated 10-year cumulative incidence rates for the key complications at the subject level were as follows: Baker grade III/IV capsular contracture, 3.6 (primary augmentation), 15.5 (revision-augmentation), 14.3 (primary reconstruction), and 16.4 (revision-reconstruction) percent; infection, 0.7 (primary augmentation), 1.9 (revision-augmentation), 1.6 (primary reconstruction), and 2.9 (revision-reconstruction) percent; explantation with or without replacement, 9.2 (primary augmentation), 25.9 (revision-augmentation), 34.1 (primary reconstruction), and 49.0 (revision-reconstruction) percent; explantation with replacement with study device, 4.0 (primary augmentation), 10.8 (revision-augmentation), 16.7 (primary reconstruction), and 27.9 (revision-reconstruction) percent; and any reoperation, 22.3 (primary augmentation), 35.0 (revision-augmentation), 52.7 (primary reconstruction), and 59.7 (revision-reconstruction) percent. CONCLUSION: The results of this study demonstrate that Contour Profile Gel/MemoryShape breast implants are safe and effective for primary and revision breast augmentation and reconstruction for women at least 22 years old.

Indications for the use of MemoryShape breast implants in aesthetic and reconstructive breast surgery: long-term clinical outcomes of shaped versus round silicone breast implants.

BACKGROUND: The availability of different styles of silicone gel implants-including traditional round devices and shaped, form-stable implants-offers a variety of choices for women undergoing breast augmentation and reconstruction. The purpose of this analysis was to characterize clinical outcomes associated with the Mentor MemoryGel (round) MemoryShape/Contour Profile Gel (shaped) devices through 9 years of use in women undergoing breast augmentation or reconstruction. METHODS: The Mentor Core studies are nonrandomized, open-label clinical trials designed to assess the long-term safety and efficacy of silicone gel breast implants. The cumulative incidence of selected complications and reoperations was estimated using the Kaplan-Meier method. Patient satisfaction was assessed by asking the patient if she would decide to have breast implant surgery again. RESULTS: Shaped implants were associated with lower cumulative incidence rates of Baker Grade III/IV capsular contracture compared with round implants (3.4% vs 11.3%, respectively, in primary augmentation, P < 0.0001; 15.6% vs 24.4% in revision-augmentation, P < 0.05). Reoperation, explantation, and infection rates were comparable between devices across cohorts, except for lower incidence of infection with shaped than round implants in primary reconstruction (1.6% vs 6.2%, P < 0.05). Rupture rates were lower with shaped implants, with significance reached in primary augmentation patients at 8 years (3.1% vs 10.3%, P < 0.05). High levels of patient satisfaction (exceeding 94%) with both devices were reported at 9 years across cohorts. CONCLUSION: Prospective data through 9 years support comparable safety of round and shaped breast implants, and high levels of patient satisfaction, in patients undergoing primary and revision breast augmentation and reconstruction.

Mentor Contour Profile Gel implants: clinical outcomes at 6 years.

BACKGROUND: MemoryShape (Contour Profile Gel) is a textured contoured implant filled with a cohesive silicone gel intended for use in aesthetic and reconstructive breast surgery. The 6-year summary of the clinical outcomes and satisfaction rates for this device from a 10-year, prospective, open-label, multicenter clinical trial is presented. METHODS: According to 2006 guidelines set forth by the U.S. Food and Drug Administration, 955 women were enrolled: 572 undergoing primary augmentation, 124 undergoing revision-augmentation, 191 undergoing primary reconstruction, and 68 undergoing revision-reconstruction. The cumulative incidence of selected complications was estimated using the Kaplan-Meier method. RESULTS: For the primary augmentation cohort, Kaplan-Meier estimated 6-year cumulative incidence rates for key complications by patient were as follows: 2.4 percent Baker grade III/IV capsular contracture, 0.9 percent infection, 7.0 percent explantation, and 18.1 percent any reoperation. Corresponding rates were 9.7, 2.1, 13.6, and 24.1 percent for revision-augmentation; 10.1, 1.6, 21.8, and 44.5 percent for primary reconstruction; and 16.4, 3.0, 34.2, and 45.4 percent for revision-reconstruction. The Kaplan-Meier estimated rupture rate at 6 years was 2.1 percent for primary augmentation, 2.9 percent for revision-augmentation, 1.5 percent for primary reconstruction, and 0 percent for revision-reconstruction. Implantation of Contour Profile Gel breast implants resulted in a significant increase in circumferential chest size in the overall population (mean change, 1.5 inches; p < 0.0001), and 96.6 percent of patients would make the same decision to have Contour Profile Gel breast implant surgery. CONCLUSIONS: At 6 years postoperatively, Contour Profile Gel breast implants were found to be effective and have an acceptable safety profile in women undergoing breast augmentation, reconstruction, and revision surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Facelifts: a contemporary perspective.

The premium that our society has placed on youthful appearance has driven an ever increasing number of patients to seek facial rejuvenation. As the demand for these procedures has increased so has the expectation that these procedures can be performed more safely while ultimately delivering a more natural appearance than has historically been possible. More focused (and often times less invasive) procedures have been developed to better serve the needs of our patients.

Rejuvenation of the aging neck: current principles, techniques, and newer modifications.

Aesthetic improvement of the neck and cervicomental angle remains one of the most challenging aspects of surgical facial rejuvenation. Individuals may become dissatisfied with the appearance of their neck because of changes in skin quality, submental fat, and muscle tone or anatomic position related to aging, weight gain, weight loss, sun damage, and other causes. To achieve the patient's desired result, surgeons use various techniques, either in isolation or in combination. Careful preoperative evaluation of the patient's anatomy dictates the most appropriate procedure, ranging from laser skin resurfacing to sub-superficial muscular aponeurotic system (sub-SMAS) rhytidectomy with an extended platysmaplasty. This article reviews the techniques that are available and the decision-making process in choosing the appropriate technique for the individual patient.

Endoscopic carpal tunnel release: a review of 753 cases in 486 patients.

BACKGROUND: Endoscopic carpal tunnel release is gaining increasing acceptance relative to the standard open carpal tunnel release for the treatment of carpal tunnel syndrome. Concerns about endoscopic carpal tunnel release include effectiveness of therapy and complication rates. This study attempted to evaluate outcomes of endoscopic carpal tunnel release in a large patient cohort. METHODS: Four hundred eighty-six patients (753 hands) with carpal tunnel syndrome who underwent endoscopic carpal tunnel release by a single surgeon were reviewed retrospectively. Data included demographics, subjective complaints, prior interventions, preoperative examination findings, and postoperative follow-up. All follow-up data were obtained from a single, independent, occupational therapy clinic. RESULTS: Median patient age was 48 years. Three hundred seventy-seven patients were gainfully employed at presentation, and 206 filed a worker's compensation claim. Median symptom duration was 2 years. Nonoperative therapy was ineffective in 151 patients. Preoperative nerve conduction studies were consistent with carpal tunnel syndrome in 472 patients (97 percent); all patients had either physical examination findings or nerve conduction studies consistent with carpal tunnel syndrome. Four hundred eighty-six patients (100 percent) obtained symptom relief. Complications included one transient median nerve neurapraxia, six complaints of residual pain, and one complaint of hypersensitivity. Worker's compensation patients and non-worker's compensation patients returned to work full-duty at similar times postoperatively. Ninety percent of employed patients returned to their original occupation. CONCLUSIONS: The authors' data indicate that an endoscopic approach for the treatment of carpal tunnel syndrome is safe and effective. Patients demonstrated a high return-to-work rate and an extremely low complication rate. The data challenge the belief that endoscopic carpal tunnel release results in higher complication rates.

A comparative study of surgical techniques on the cervicomental angle in human cadavers.

BACKGROUND: The cervicomental (CM) angle is formed by the horizontal plane of the submental region and the vertical plane of the neck. OBJECTIVE: To compare the 2-dimensional effect of 4 surgical techniques on the CM angle in a human cadaver model. DESIGN: Anatomic presurgical and postsurgical comparative study performed on human cadavers preserved with ethylene glycol. SETTING: Academic medical research center in St Louis, Mo. SUBJECTS: Twelve cadaver specimens with obtuse CM angles with heads attached to the sternum and upper thorax. INTERVENTIONS: Standard superficial musculoaponeurotic system rhytidectomy techniques were performed on all cadaver heads. Four techniques were compared: (1) platysmal plication; (2) platysmal plication and plication of the anterior bellies of the digastrics; (3) platysmal plication, plication of the anterior bellies of the digastrics, and interlocking mastoid-to-mastoid sutures; and (4) platysmal plication and interlocking mastoid-to-mastoid sutures. MAIN OUTCOME MEASURES: The comparative changes in CM angle, the distance between the mentum and CM angle (mentum-CM distance), and the distance between the sternum and CM angle (sternum-CM distance) obtained with each of the 4 surgical techniques. Anatomic characteristics of the cadavers were also noted. RESULTS: On average, the CM angle was significantly reduced after all procedures (P<.001). The mean sternum-CM distance increased significantly (P =.01). A trend toward significance was observed in the change in mentum-CM distance (P =.10). The presence of a low hyoid was significantly associated with a smaller CM angle after surgery (P =.009) and demonstrated a trend toward significance with an increase in mentum-CM distance (P =.07), but it was not significantly associated with an increase in sternum-CM distance (P =.58). After controlling for the presence of a low hyoid, the mastoid-to-mastoid suture significantly reduced the CM angle by approximately 11.3 degrees (P =.002) and the sternum-CM distance by 1.15 cm (P<.001). CONCLUSIONS: The CM angle and the sternum-CM distance were significantly affected by all procedures. The addition of the mastoid-to-mastoid suture had the greatest effect on the CM angle, and the reduction in CM angle was strongly associated with an increase in the sternum-CM distance. Presence of a low hyoid was the only preoperative factor associated with a significant postoperative reduction in CM angle.

Modifications in rejuvenation of the aging neck.

Surgical treatment of the aging neck should be approached according to the particular anatomic characteristics of the patient. One size does not fit all when speaking of cervicofacial rejuvenation. This article discusses some of the newer techniques used in rejuvenation of the aging neck.