Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants.

BACKGROUND: Natrelle 410 silicone breast implants are approved in the United States for breast augmentation, reconstruction, and revision. METHODS: In two ongoing, prospective, multicenter 10-year studies, 17,656 subjects received Natrelle 410 implants for augmentation (n = 5059), revision-augmentation (n = 2632), reconstruction (n = 7502), or revision-reconstruction (n = 2463). Capsular contracture, implant malposition, and late seroma were documented. Cox proportional hazards regression analyses evaluated potential associations between subject-, implant-, and surgery-related factors and these complications. RESULTS: Median follow-up was 4.1, 2.6, 2.1, and 2.3 years in the augmentation, revision-augmentation, reconstruction, and revision-reconstruction cohorts, respectively. Incidence of capsular contracture across cohorts ranged from 2.3 to 4.1 percent; malposition, 1.5 to 2.7 percent; and late seroma, 0.1 to 0.2 percent. Significant risk factors for capsular contracture were subglandular implant placement, periareolar incision site, and older device age in the augmentation cohort (p < 0.0001), older subject age in the revision-augmentation cohort (p < 0.0001), and higher body mass index (p = 0.0026) and no povidone-iodine pocket irrigation (p = 0.0006) in the reconstruction cohort. Significant risk factors for malposition were longer incision size in the augmentation cohort (p = 0.0003), capsulectomy at the time of implantation in the reconstruction cohort (p = 0.0028), and implantations performed in physicians' offices versus hospitals or standalone surgical facilities in both revision cohorts (p < 0.0001). The incidence of late seroma was too low to perform risk factor analysis. CONCLUSIONS: These data reaffirm the safety of Natrelle 410 implants. Knowledge of risk factors for capsular contracture and implant malposition offers guidance for reducing complications and optimizing outcomes. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Medicolegal Issues in Breast Reduction.

Areas of general risk are discussed with patients before surgery. Procedure-specific risks inherent in each technique are a key part of informed consent. Issues related to insurance coverage must be settled preoperatively to decrease litigation risk. Protection of patient information has become a key part of the overall treatment process and this information must be protected.

A systematic examination of the effect of tissue glues on rhytidectomy complications.

BACKGROUND: Fibrin glue has widespread use in multiple fields of surgery. There have been numerous studies on the use of fibrin glue in facelifts, with no consensus regarding differences in outcomes. OBJECTIVES: This study compared the risk of hematoma, seroma, and the 24-hour drainage volume in all published prospective controlled trials. METHODS: A MEDLINE search of English-language articles on fibrin glue and rhytidectomy published up to July 2013 yielded 49 citations. After screening, we examined 7 relevant controlled trials. The DerSimonian and Laird random-effects model was used to perform the meta-analysis. RESULTS: Seven controlled trials measuring the outcomes of fibrin glue in facelifts were used to estimate the pooled relative risk of complications and confidence intervals. Hematoma formation was four times less likely with the use of fibrin glue (relative risk 0.25, P = .002). There was no significant reduction in seroma formation (relative risk 0.56, P = .19). There was not enough data to properly measure 24-hour drainage and ecchymoses. CONCLUSIONS: This analysis suggests that fibrin glue reduces the rates of hematoma formation, but does not significantly reduce the rates of seroma development. LEVEL OF EVIDENCE: 3 Therapeutic.

Breast implant-associated anaplastic large cell lymphoma: sensitivity, specificity, and findings of imaging studies in 44 patients.

UNLABELLED: Breast implant-associated anaplastic large cell lymphoma (BIA ALCL) is a newly described clinicopathologic entity. The purpose of this study is to describe the imaging findings of patients with BIA ALCL and determine their sensitivity and specificity in the detection of the presence of an effusion or a mass related to BIA ALCL. A retrospective search was performed of our files as well as of the world literature for patients with pathologically proven BIA ALCL who had been assessed by any imaging study including ultrasound (US), computerized tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT, as well as mammography. The sensitivity and specificity of each imaging modality in the detection of an effusion or a mass around breast implants was determined. We identified 44 patients who had BIA ALCL and imaging studies performed between 1997 and 2013. The sensitivity for detecting an effusion was 84, 55, 82, and 38 %, and for detecting a mass was 46, 50, 50, and 64 %, by US, CT, MRI, and PET, respectively. The sensitivity of mammography in the detection of an abnormality without distinction of effusion or mass was 73 %, and specificity 50 %. Progression-free survival was worse in patients with an implant-associated mass (p = 0.001). CONCLUSIONS: Current imaging with US, CT, MR, and PET appears suboptimal in the detection of an imaging abnormality associated with BIA ALCL. This under diagnosis may reflect a lack of awareness of this rare entity suggesting the need for better understanding of the spectrum of imaging findings associated with BIA ALCL by breast imagers.

Clinical trial outcomes of high- and extra high-profile breast implants.

BACKGROUND: Clinical data concerning potential risks and benefits associated with the use of high- and extra high-profile breast implants are lacking. OBJECTIVES: The authors assess the risk of adverse events (AE) with high- and extra high-profile breast implants compared with low- to moderate-profile breast implants in patients enrolled in long-term clinical studies. METHODS: Relative risks (RR) of capsular contracture (CC), moderate to severe malposition, and secondary procedure were calculated using Cox proportional hazards regression, adjusting for patient, procedure, and device characteristics among patients enrolled in the primary augmentation cohorts of the Core (NCT00689871; round, silicone-filled implants) and 410 (NCT00690339; shaped, highly cohesive silicone-filled implants) clinical studies. Study pooling provided comparisons of implant shape and fill, as well as contributed to relative outcome. Analyses were also stratified by preoperative breast measures. RESULTS: In the Core study (N = 454; 907 implants; mean follow-up 7.2 years; 3669 person-years), and the combined Core and 410 studies (N = 4412; 8811 implants; mean follow-up 3.0 years; 14 528 person-years), risk of CC, secondary procedures, and mastopexy as a secondary procedure were reduced in high-profile versus low- to moderate-profile breast implants (P < .05). The risk of moderate to severe malposition was not significantly different between high-profile and low- to moderate-profile breast implants in the Core or combined studies (RR, 0.58 [95% confidence interval (CI), 0.22-1.51] and RR, 0.72 [95% CI, 0.31-1.70], respectively). Analyses stratified by preoperative breast measures did not indicate higher risk of CC, malposition, or secondary procedure among patients with either smaller (<17 cm) or larger (≥17 cm) preoperative measures. CONCLUSIONS: Among primary augmentation patients with round, silicone-filled, or shaped, highly cohesive silicone-filled implants, high- and extra high-profile implants were associated with lower risks of CC, secondary procedures, and mastopexy and were not associated with greater risks of moderate to severe malposition versus low- to moderate-profile implants. LEVEL OF EVIDENCE: 3.

Managing late periprosthetic fluid collections (seroma) in patients with breast implants: a consensus panel recommendation and review of the literature.

BACKGROUND: The goal of this consensus is to establish an algorithm for the management of patients who develop a late or delayed periprosthetic fluid collection. A work group of practicing plastic surgeons and device industry physicians met periodically by teleconference and discussed issues pertinent to the diagnosis and management of late periprosthetic fluid collections in patients with breast implants. Based on these meetings, treatment recommendations and a treatment algorithm were prepared in association with an editorial assistant. METHOD: The work group participants discussed optimal care approaches developed in their private practices and from evidence in the literature. RESULTS: The consensus algorithm and treatment and management recommendations represent the consensus of the group. CONCLUSIONS: The group concluded that late periprosthetic fluid collection (arbitrarily defined as occurring ≥ 1 year after implant) is an infrequently reported occurrence (0.1 percent) after breast implant surgery and that, at a minimum, management should include clinically indicated ultrasound-guided aspiration of fluid, with appropriate cultures and cytologic testing. Further evaluation and additional treatment is recommended for recurrence of periprosthetic fluid collection after aspiration, or clinical suspicion of infection or neoplasia.

Evidence-based patient safety advisory: liposuction.

Liposuction is considered to be one of the most frequently performed plastic surgery procedures in the United States, yet despite the popularity of liposuction, there is relatively little scientific evidence available on patient safety issues. This practice advisory provides an overview of various techniques, practices, and management strategies that pertain to individuals undergoing liposuction, and recommendations are offered for each issue to ensure and enhance patient safety.

Evidence-based patient safety advisory: blood dyscrasias.

Rarely, patients with blood disorders may seek to undergo plastic surgery. Although plastic surgeons are not expected to diagnose or manage blood disorders, they should be able to recognize which patients are suitable for surgery and which should be referred to a hematologist before a procedure. This practice advisory provides an overview of the perioperative steps that should be completed to ensure appropriate care for patients with blood disorders.

Ethics, legal issues, and consent for fillers.

The huge patient demand for filler rejuvenation exposes plastic surgeons to legal issues. Plastic surgery statistics confirm a trend toward nonsurgical procedures, with a slight increase in surgical procedures overall from 2004 to 2005. Nonsurgical procedures, especially fillers, exhibited a 35% increase. Patients are seeding a quick-recovery, minimally invasive procedure that provides them maximal rejuvenation. This demand and media-driven exposure may create concerns for plastic surgeons as to patient selection and ethical, regulatory, and legal issues relating to filler choices and their use. This article addresses these concerns.

Decision and management algorithms to address patient and food and drug administration concerns regarding breast augmentation and implants.

During the U.S. Food and Drug Administration's advisory panel hearings to evaluate the premarket approval for conventional silicone gel implants on October 14 and 15, 2003, panel members and patient advocate representatives focused on four specific areas of concern: reoperation rates in primary breast augmentation; levels, depth, and methods of patient education and informed consent; modes, frequency, and management of silicone gel implant device failures, including management of "silent" ruptures; and methods of monitoring and managing symptoms or symptom complexes that may or may not be associated with connective tissue disease or other undefined symptom complexes. These concerns, with a reported 20 percent reoperation rate for primary augmentation within just 3 years, and a lack of concise, definitive management protocols addressing these areas of concern may have contributed to the Food and Drug Administration's rejection of the premarket approval, despite the panel's recommendation for approval. This article presents decision and management algorithms that have been used successfully for 7 years in a busy breast augmentation practice (Tebbetts and Tebbetts). The algorithms have been further expanded and refined by a group of surgeons with diverse experiences and expertise to address the following clinical situations that coincide with concerns expressed by patients and the Food and Drug Administration: implant size exchange, grade III to IV capsular contracture, infection, stretch deformities (implant bottoming or displacement), silent rupture of gel implants, and undefined symptom complexes (connective tissue disease or other). In one practice (Tebbetts and Tebbetts) that uses the TEPID system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant), implant selection is based on quantified patient tissue characteristics, pocket selection is based on quantified soft-tissue coverage, and anatomic saline implants have fill volumes that are designed to minimize shell collapse and fold fatigue; in this practice, the algorithms contributed to a 3 percent overall reoperation rate in 1662 reported cases with up to 7 years of follow-up, compared with a 20 percent reoperation rate at 3 years in the 2003 premarket approval study.

Legal issues associated with the current and future practice of anti-aging medicine.

This article addresses legal issues and laws that govern physicians, medications, drugs, and the safety of patients in age management and anti-aging medical practices. Age management programs continue to increase and attract more patients despite the lack of scientific proof of their medical benefits. The use of growth hormone, other medications, and supplements is widely reported, although prohibited by the Food and Drug Administration for the treatment of anti-aging. The categories of potential legal liability presented in this article include False Expectations, Fraud, Negligence-Malpractice, Warranty Issues, Product Liability, Human Growth Hormone Usage, and Agency (employee) Issues. This article attempts to identify potential areas of liability for the age management practitioner and the patient seeking such care.