Diane K. Murphy

Inamed silicone breast implant core study results at 6 years.

Background: Silicone gel–filled breast implants were developed in 1962 but did not fall under the auspices of the U.S. Food and Drug Administration until 1976 and were not classified as class III devices until 1988. This set the stage for a series of Food and Drug Administration advisory panel meetings and a moratorium on the sale of these implants from 1992 until 2006, when sufficient clinical data were presented to demonstrate their safety. Methods: This study was conducted under the rigorous framework of a Food and Drug Administration–approved investigational device exemption to document the safety and effectiveness of Inamed silicone-filled breast implants through 10 years. Of 940 female subjects, approximately half were augmentation subjects, one-quarter were reconstruction subjects, and one-quarter were revision subjects. Follow-up visits were conducted at 0 to 4 weeks, 6 months, 1 year, and annually thereafter. Approximately one-third of subjects also underwent biennial magnetic resonance imaging evaluation to detect silent rupture. Primary statistical analyses used the Kaplan-Meier product limit method. Results: Data through 6 years are currently available from the 10-year study, with patient follow-up rates for that visit ranging from 78 to 92 percent per cohort. As expected, the most common local complication in all cohorts was capsular contracture, occurring in 15 to 20 percent of subjects. The by-implant rupture rate was 3.5 percent overall at 6 years. Satisfaction with implants was uniformly high throughout the study period, with 6-year rates of 95 percent for augmentation subjects and 94 percent for reconstruction subjects. Conclusion: Study results demonstrate the safety and effectiveness of Inamed silicone-filled breast implants through 6 years, including a low rupture rate and high satisfaction rate.

Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation.

Background: Inamed introduced a fourth-generation implant, the Style 410 cohesive silicone breast implant, in 1993. To date, little has been published on this implant despite its widespread use in Europe, and no data are available on its long-term rupture rate. Methods: Women implanted with Style 410 implants between 1995 and 1999 at Akademikliniken Hospital in Stockholm were eligible to participate in the study. One hundred forty-four of 302 potential subjects received a physical examination, underwent magnetic resonance imaging screening for silent rupture, and completed a quality-of-life survey. The majority of subjects were Caucasian (96 percent), with a median age of 39 years. The study population consisted of subjects with cosmetic augmentation (86 percent) or revision of previous breast implantation (14 percent). Median time elapsed between physical examination and magnetic resonance imaging was 2 days. Results: The 144 subjects provided 286 implants for magnetic resonance imaging assessment, with a median implantation time of 6 years (range, 5 to 9 years). Overall, 99.0 percent of implants showed no evidence of rupture, 0.3 percent showed evidence of rupture, and 0.7 percent were indeterminate. The most common complication noted at physical examination was capsular contracture (5.6 percent). All other complications occurred in less than 3 percent of subjects. Quality-of-life results found an improvement in overall sense of well-being for 87 percent of subjects. Most compelling is that 97 percent stated an overall feeling that their breast implantation had been advantageous. Conclusions: The authors’ findings support the long-term safety and effectiveness of Inamed Style 410 cohesive breast implants and demonstrate a low prevalence of rupture.

Natrelle style 410 form-stable silicone breast implants: core study results at 6 years.

BACKGROUND The Natrelle Style 410 shaped, form-stable silicone gel implant (Allergan, Inc; Irvine, California) has been the subject of a pivotal study that supports potential US Food and Drug Administration approval of the device. The 3-year results of this study were reported previously. OBJECTIVES The authors update the safety and effectiveness findings for the Natrelle Style 410 implants through 6 years of study. METHODS This prospective, nonrandomized, multicenter study included 941 patients (492 primary augmentations, 156 revision-augmentations, 225 primary reconstructions, and 68 revision-reconstructions). Since the original 3-year report, follow-up visits have been conducted annually. Kaplan-Meier risk rates were calculated for local complications, reoperations, and explantations. One-third of the subjects were enrolled in the magnetic resonance imaging (MRI) cohort and underwent biannual MRI rupture screening. Effectiveness was measured by subject satisfaction on a 5-point scale. RESULTS As expected after breast implantation, capsular contracture (CC) was one of the most common complications, with 6-year risk rates of 4.6% for augmentation, 6.9% for revision-augmentation, 10.7% for reconstruction, and 18.3% for revision-reconstruction. The rates for CC among augmentations and revision-augmentations were significantly lower with the Natrelle 410 implants than with other standard gel implants. The rupture rate (confirmed plus suspected) across all cohorts was 6.4% by subject and 3.8% by implant. The most common reasons for reoperation were style or size change (augmentation), implant malposition (revision-augmentation), scarring (reconstruction), and CC (revision-reconstruction). The satisfaction rate exceeded 80% in all cohorts. CONCLUSIONS These fifth-generation, form-stable implants represent another option to achieve desired aesthetic outcomes with minimal complications.

Style 410 highly cohesive silicone breast implant core study results at 3 years.

Background: In February of 2001, Allergan (formerly Inamed) began an Investigational Device Exemption study of a shaped breast implant: the Style 410 highly cohesive silicone-filled breast implant. Methods: Forty-eight plastic surgeons across the United States performed implantation on 941 subjects enrolled in a 10-year study. This prospective, nonrandomized study provided 3-year follow-up data, clinical outcomes, and satisfaction rates from this cohort of 492 primary augmentation, 225 breast reconstruction, and 224 breast revision subjects. Complications were reported and compared with those from current standard gel and saline implant studies. Results: With greater than 85 percent follow-up compliance at 3 years, complication rates were low among augmentation subjects, with implant malposition being the most common (2.6 percent) and all other complications occurring in less than 2 percent of subjects. In the revision-augmentation group, the most common complications were capsular contracture (4.8 percent) and implant malposition (4.7 percent), with all other complications occurring in less than 4 percent. Asymmetry (8.7 percent) and capsular contracture (5.9 percent) were the only complications that occurred in more than 5 percent of reconstruction subjects. The overall risk of rupture across all cohorts was 1.0 percent by subject and 0.8 percent by implant. Subject satisfaction with implants was 98 percent for augmentation and 90 percent or higher for all other cohorts. Conclusions: The Style 410 highly cohesive silicone implant has low complication rates and high satisfaction rates through 3 years after implantation. These results are significant in introducing more evidence-based medicine that will allow plastic surgeons and patients to make better informed decisions regarding implant options.

Natrelle round silicone breast implants: Core Study results at 10 years.

Background: Allergan’s Natrelle round silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006 based on interim results from the Core Study; final 10-year study results are now available. Methods: Seven hundred fifteen subjects were implanted with smooth and Biocell textured Natrelle round silicone implants and attended clinic visits at 0 to 4 weeks, 6 months, 1 year, and annually through 10 years. Approximately one-third of subjects underwent magnetic resonance imaging at years 1, 3, 5, 7, and 9 to assess rupture. Results: Complication rates showed modest increases over the previously published 6-year rates. The Kaplan-Meier capsular contracture rate was 18.9 percent for augmentation, 28.7 percent for revision-augmentation, and 24.6 percent for reconstruction. Among augmentation subjects, capsular contracture was significantly lower (p = 0.023) for submuscular (15.7 percent) versus subglandular (26.3 percent) placement. The overall rupture rate in the magnetic resonance imaging cohort was 13.0 percent for subjects and 7.7 percent for implants. By the end of the study, 81.8 percent of augmentation subjects still had an original implant in place. Using a five-point scale, 94.2 percent of augmentation, 83.8 percent of revision-augmentation, and 90.7 percent of reconstruction subjects reported being satisfied or definitely satisfied with their implants. Significant improvement over baseline was also seen in overall breast satisfaction and satisfaction with breast size, shape, feel, and how well they matched. Conclusion: The 10-year data from the Natrelle Core Study, which can guide surgeons and patients in decision-making, demonstrate safety and high levels of patient satisfaction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence.

Few implantable medical devices have been studied for their safety more extensively than silicone gel-filled breast implants. We summarize the epidemiologic evidence on the safety of breast implants, most of which is drawn from large cohort studies with long-term follow-up. The topics addressed in this report include cancer, breast cancer detection, connective tissue disease, suicide, offspring effects, neurologic disease, implant rupture, and local perioperative complications and additional surgery. We conclude that the weight of the epidemiologic evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurologic disease. Women with breast implants do not present with more advanced stages of breast cancer or suffer impaired survival after breast cancer diagnosis. The only study to examine an actual incidence rate of breast implant rupture reported rupture-free survival of 98% at 5 years and 83%–85% at 10 years for newer “third-generation” implants. Future studies are needed to determine whether the consistently observed excess of suicide among women with implants reflects underlying psychiatric illness prior to breast augmentation surgery or other factors.

Ten-year results from the Natrelle 410 anatomical form-stable silicone breast implant core study.

Background Silicone breast implants have long been used for breast augmentation and reconstruction. During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome performance. Objectives The authors conducted a 10-year study to determine the safety and effectiveness of Natrelle 410 silicone breast implants. Methods This prospective, multicenter study enrolled 941 subjects who were undergoing either augmentation, augmentation revision, reconstruction, or reconstruction revision. Data on complications, reoperations, explantations, and subject satisfaction were collected at annual clinic visits, and one-third of subjects underwent biennial magnetic resonance imaging (MRI) to screen for implant rupture. The authors used the Kaplan-Meier estimator to calculate risk rates for local complications, reoperations, and explantations. Results Capsular contracture rates increased approximately 1% per year from the previously reported 6-year rates. The rates were significantly lower than those from the Natrelle round gel core study. The overall rate of confirmed ruptured implants in subjects who underwent MRI was 5.7%. Eleven late seromas were reported. The most common reason for explantation was a subject requesting a size or style change. Satisfaction rates remained high through 10 years, with most subjects saying they were somewhat or definitely satisfied with their implants. Conclusions This 10-year prospective trial demonstrated the long-term safety and effectiveness of Natrelle 410 anatomical form-stable implants. The complication rates were low and the satisfaction rates were high. Level of Evidence: 1 Therapeutic

A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine.

Introduction  Pain is a common patient complaint during dermal filler injections. The primary objective of this study was to compare a new formulation of Juvéderm® injectable gel with lidocaine (denoted as JUV + L) to commercially‐available Juvéderm® injectable gel without lidocaine (denoted as JUV) with respect to procedural pain scores in subjects desiring nasolabial fold (NLF) correction.

Effectiveness of Juvéderm Ultra Plus dermal filler in the treatment of severe nasolabial folds.

Background: With the baby boomer generation firmly ensconced in middle age and the ubiquity of botulinum toxin type A, nonsurgical facial rejuvenation is becoming increasingly prevalent. As this generation continues to age, products with greater therapeutic power to correct aging changes will be in growing demand. Methods: A multicenter, double-blind, randomized, within-subject, controlled study was conducted comparing Juvéderm Ultra Plus hyaluronic acid filler with bovine collagen. A subset of subjects classified as having treatment for severe nasolabial folds is presented in this article. Subjects received Juvéderm Ultra Plus in one severe nasolabial fold and Zyplast collagen in the other nasolabial fold; up to two touch-up treatments were allowed at 2-week intervals. Nasolabial fold severity was evaluated every 4 weeks for 24 weeks using a five-point scale. Treatment site reactions and adverse events were also recorded. A complimentary treatment was offered at the end of the trial, with effectiveness evaluations just before retreatment and up to 48 weeks after repeated treatment for a subset of subjects. Results: Of the 87 subjects, most were female Caucasians, but all Fitzpatrick skin types were represented (36 percent types IV through VI). At 24 weeks, 96 percent of nasolabial folds treated with Juvéderm had maintained clinically significant correction, and 81 percent maintained the correction for 1 year or more. Results were similar for those subjects with follow-up through 48 weeks after repeated treatment. The median volume required for repeated treatment with Juvéderm was significantly less than that for initial treatment (0.7 ml versus 1.6 ml). Conclusion: Juvéderm Ultra Plus provides correction of severe nasolabial folds through 1 year or more.

Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: 2-Year Results from a Pivotal Single-Blind Randomized Controlled Study

BACKGROUND Hyaluronic acid (HA) gels are commonly used to correct age‐related midface volume deficit (MVD), yet the Food and Drug Administration has not specifically approved them for this purpose. OBJECTIVE To study the safety and effectiveness of a new 20‐mg/mL HA gel (VYC‐20L) specifically formulated and optimized for mid‐face volumizing. METHODS AND MATERIALS A multicenter, single‐blind, controlled study randomized 235 subjects aged 35 to 65 with MVD to a treatment group and 47 to a no‐treatment control group. Responders were defined as subjects who achieved improvement of 1 point or more on the validated 6‐point Mid‐Face Volume Deficit Scale (MFVDS) at 6 months as rated live by two blinded independent evaluators. The primary endpoint required a 70% or greater treatment group response and a statistically significant difference (p < .001) between the treatment and control group responder rates. RESULTS The primary endpoint was met, with 85.6% of the treatment group improving by 1 point or more on the MFVDS at month 6 and a statistically significant difference (p < .001) between the treatment and control group responder rates. Subjects tolerated VYC‐20L well, with no unanticipated adverse device effects. Nearly half of subjects maintained correction for 24 months. CONCLUSION VYC‐20L is safe and effective for age‐related MVD, with correction lasting up to 2 years.