Neal R. Reisman

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

Summary: 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.

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.

Use of off-label and non-approved drugs and devices in plastic surgery.

Our ultimate goal as plastic surgeons is to provide the best possible result for our patients with the minimum amount of morbidity. In our rapidly expanding technological world, various drugs and devices have been developed in the hope of continual improvement of outcomes and, therefore, patient satisfaction. According to a joint advisory issued by the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery,1 “the use of drugs and devices on humans within the United States falls into one of three categories”:

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.

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.

Evidence-Based Patient Safety Advisory: Blood Dyscrasias

Summary: 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.

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.

Commentary on: Factors Influencing Judicial Decisions on Medical Disputes in Plastic Surgery.

The Brazilian experience described by Vila-Nova da Silva et al demonstrates the importance of informed consent and a good medical record, defined as including informed consent information, preoperative and postoperative photographs, and information allowing an outside expert to adequately review the chart.1 That may be where this study stops reflecting similarities to our system. The reality is there are similar areas of litigation in the US by procedure. Informed consent documentation can be quite good when signed by the patient and demonstrating an understanding of the potential inherent risks and complications each procedure includes. The key difference lies in expectations. Expectations have become generally quite unrealistic. I have reviewed litigation at the end of the first stage of a reconstruction where two additional procedures are intended, but the patient is dissatisfied at the beginning. I have reviewed litigation …