Long-term outcomes with the McGhan Style 153 dual-lumen breast implant: Implications for future implant design.

BACKGROUND: A variety of saline and silicone implants have been introduced over the years to optimize the shape, aesthetic result and safety profile for use in breast surgery. The McGhan Style 153 dual-lumen silicone implant represented an early generation of anatomically shaped implants later removed from the market due to a high rate of rupture. This study reports long term outcomes and complications, including a revised rupture rate, and discusses potential mechanisms of implant failure and their implications for future implant design. METHODS: A retrospective review was performed on 79 patients (134 implants). Demographics, operative details, outcomes, and complications were recorded. Rupture rate and location of rupture were included. RESULTS: The revised implant rupture rate was 36.6% of implants. At least one rupture occurred in 49.4% of patients. Clinical exam was the most common method of detection (55.1% of ruptures). The most common location of rupture was the superior pole (30.6%), followed by a posterior location (24.5%). The capsular contracture rate (Baker grade III/IV) was 51.5%. The total implant removal rate (for rupture, contracture, size change, or asymmetry) was 77.6%. The average time to implant removal was 91.8 months, or 7.5 years (±47.3 months). Average follow up was 120.7 months or 10 years (±49.9 months). DISCUSSION: The experiences with this anatomic gel implant highlight the importance of shell stability over time, suitable gel cohesiveness to support the asymmetric anatomic shape, avoidance of fold flaws due to wrinkling, and the prevention of distinct stress points on the shell that can result from dual lumen or multi-compartment designs. LEVEL OF EVIDENCE: Level III, retrospective cohort, therapeutic study.

Potential costs of breast augmentation mammaplasty.

BACKGROUND: Augmentation mammaplasty is one of the most common surgical procedures performed by plastic surgeons. The aim of this study was to estimate the cost of the initial procedure and its subsequent complications, as well as project the cost of Food and Drug Administration (FDA)-recommended surveillance imaging. METHODS: The potential costs to the individual patient and society were calculated. Local plastic surgeons provided billing data for the initial primary silicone augmentation and reoperative procedures. Complication rates used for the cost analysis were obtained from the Allergen Core study on silicone implants. Imaging surveillance costs were considered in the estimations. RESULTS: The average baseline initial cost of silicone augmentation mammaplasty was calculated at $6335. The average total cost of primary breast augmentation over the first decade for an individual patient, including complications requiring reoperation and other ancillary costs, was calculated at $8226. Each decade thereafter cost an additional $1891. Costs may exceed $15,000 over an averaged lifetime, and the recommended implant surveillance could cost an additional $33,750. DISCUSSION: The potential cost of a breast augmentation, which includes the costs of complications and imaging, is significantly higher than the initial cost of the procedure. LEVEL OF EVIDENCE: Level III, economic and decision analysis study.

A retrospective comparison of the management of recalcitrant lateral elbow tendinosis: platelet-rich plasma injections versus surgery.

BACKGROUND: The aim of this study is to compare the outcomes of platelet-rich plasma (PRP) injections to surgical release and decortication for lateral elbow tendinosis within a similar patient population. METHODS: A retrospective chart review was performed on two groups of patients, receiving either PRP injections (n = 28) or surgery (n = 50). Patient demographics, clinical presentation, pain score, worker's compensation status, and previous steroid injections were recorded. Primary outcomes included pain and symptom improvement, range of motion, return to work, and postoperative complications. RESULTS: Demographics, duration of symptoms, and exam findings were similar between the PRP and surgical patients. There was no significant difference in pain and symptom improvement. Pain improvement was reported in 89.3 % of PRP patients and 84 % of surgical patients, with a reported percent reduction in pain of 61.1 and 55 %, respectively. Symptoms other than pain improved in 85.7 and 88 % of the PRP and surgical patients, respectively. Tenderness to palpation at the lateral epicondyle (64.3 % PRP, 44 % surgical), pain with resisted wrist extension (35.7 % PRP, 30 % surgical), or residual symptoms other than pain (14.3 % PRP, 10 % surgical) were not significantly different between groups at last follow-up. Eighty-two percent of patients in both the PRP and surgical groups returned to work. No complications were reported. Mean follow-up was 315 vs. 352 days for the PRP and surgical groups, respectively. CONCLUSIONS: Similar outcomes in pain improvement and return to work may be achievable with either PRP injections or surgery in recalcitrant lateral elbow tendinosis. PRP injections may be a reasonable alternative for patients apprehensive to proceed with surgery or poor surgical candidates.

Treatment of breast animation deformity in implant-based reconstruction with pocket change to the subcutaneous position.

UNLABELLED: Breast animation may be an unfortunate result of subpectoral implant-based reconstruction following mastectomy. This article reviews a novel approach to the treatment of animation deformity in cases of reconstruction, whereby the pectoralis major muscle is sutured down to the chest wall and the implant is transferred to the subcutaneous plane. A retrospective review was performed on 19 breasts undergoing pocket change. In selected cases, fat grafting was added to augment the soft-tissue framework around the implant. Demographics, operative details, outcomes, and complications were recorded. All 19 breasts had complete resolution of their animation deformity. Complications were seen in five breasts (26.3 percent). Four breasts (21.1 percent) developed Baker grade III or IV capsular contracture requiring capsulectomy that was curative. One seroma (5.3 percent) required in-office drainage. There were no visible implant deformities, infections, or implant removals. In appropriately selected patients, pocket change to a subcutaneous plane is a safe and effective technique for correction of severe animation deformity following implant-based breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Microbial growth within saline-filled tissue expanders.

BACKGROUND: Tissue expander based reconstruction is the most common restorative procedure used following mastectomy. Infection is a common complication in the post-operative period and may lead to failure of the reconstruction. Various previous studies have investigated the potential sources of infection during these procedures. The purpose of this study was to examine the fluid within the saline-filled tissue expander at time of implant exchange for the presence of microbial growth. METHODS: Twenty-five patients (39 breasts) were enrolled in the study. Fluid samples were sent for Gram stain, aerobic, anaerobic, fungal, and acid-fast bacilli (AFB) cultures. Average age was 53.1. Mean time to exchange was 7.7 months. Average follow-up was 25 months. RESULTS: None of the samples were positive for microbial growth at final culture (0/39). DISCUSSION: These results show the tissue expander fluid maintains a microbial-free environment during the expansion process, and is unlikely a significant source of contamination in cases of infection. LEVEL OF EVIDENCE: Level II, prospective cohort, therapeutic study.