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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.