Biofilm-derived oxylipin 10-HOME-mediated immune response in women with breast implants.

This study investigates a mechanistic link of bacterial biofilm-mediated host-pathogen interaction leading to immunological complications associated with breast implant illness (BII). Over 10 million women worldwide have breast implants. In recent years, women have described a constellation of immunological symptoms believed to be related to their breast implants. We report that periprosthetic breast tissue of participants with symptoms associated with BII had increased abundance of biofilm and biofilm-derived oxylipin 10-HOME compared with participants with implants who are without symptoms (non-BII) and participants without implants. S. epidermidis biofilm was observed to be higher in the BII group compared with the non-BII group and the normal tissue group. Oxylipin 10-HOME was found to be immunogenically capable of polarizing naive CD4+ T cells with a resulting Th1 subtype in vitro and in vivo. Consistently, an abundance of CD4+Th1 subtype was observed in the periprosthetic breast tissue and blood of people in the BII group. Mice injected with 10-HOME also had increased Th1 subtype in their blood, akin to patients with BII, and demonstrated fatigue-like symptoms. The identification of an oxylipin-mediated mechanism of immune activation induced by local bacterial biofilm provides insight into the possible pathogenesis of the implant-associated immune symptoms of BII.

Fat Grafting as a Novel Treatment for Xerostomia.

PURPOSE: Within the context of xerostomia, there is evidence that adipose-derived stem cells (ASCs) can differentiate into salivary gland cells in the appropriate environment. The purpose of this study was to preliminarily investigate whether fat grafting as practiced in the United States would be an effective treatment for xerostomia. METHODS: Patients were selected for the study if they were seeking treatment for xerostomia after radiation treatment to the head and neck for cancer treatment. Fat grafting was performed in bilateral parotid and submandibular glands. Visual Analog Scale (VAS) of xerostomia was used both preoperatively and postoperatively to assess the effect upon xerostomia symptoms. RESULTS: Nine patients were included in this study. All patients had complaints of long-standing xerostomia. The average preoperative VAS score was 9.1. All patients tolerated all rounds of fat grafting with no complications. The average postoperative VAS score was 6.0. Compared to preoperative scores, all patients had improvement in VAS scores. The decrease in average VAS score postoperatively (9.1 versus 6.0) was statistically significant (P = 0.007). CONCLUSIONS: Our study showed that there was improvement in xerostomia symptoms with autologous fat transfer alone. This is a novel finding for fat grafting demonstrating regenerative potential. There has been extensive basic research that has shown that adipose-derived mesenchymal stem cells can have a protective and restorative role after salivary gland radiation damage. Our case series is the first report of fat grafting having a similar reported outcome.Level of Evidence: 4.

To Post or Not to Post: Plastic Surgery Practice Marketing, Websites, and Social Media?

Social media is beginning to eclipse practice websites and other traditional electronic marketing utilized by plastic surgeons. First, highlights are presented from the relevant electronic marketing literature. Next, this article presents a new case study of how, why, when, and what social media is being used by ASPS members (n = 100). Results suggest a significant disconnect between plastic surgeons and the highest impact platforms reported in the literature such as Instagram, YouTube, Snapchat, and Facebook. Plastic surgeons currently prefer to focus electronic marketing efforts on practice websites over social media platforms. This study suggests that instead of relying on their practice websites to disseminate information, surgeons should be utilizing social media, posting promotions, before-and-after photos, and videos to develop their client base.

The Use of Poly-4-Hydroxybutyrate (P4HB) Scaffold in the Ptotic Breast: A Multicenter Clinical Study.

BACKGROUND: Mastopexy and reduction mammaplasty are often limited by the patient's poor native soft tissue quality, resulting in ptosis recurrence and loss of rejuvenated surgical results. Surgical scaffolds and acellular dermal matrices are used in these procedures to provide physical and mechanical stabilization of weakened or compromised tissue. GalaFLEX scaffold, made from poly-4-hydroxybutyrate (P4HB), is a next-generation product for soft tissue reinforcement that resorbs gradually while aiding tissue regeneration to achieve excellent outcomes. OBJECTIVES: To assess the clinical performance of GalaFLEX scaffold in soft tissue reinforcement during elective mastopexy and reduction mammaplasty. METHODS: This multicenter, single-arm, observational study assessed product performance and outcomes of GalaFLEX scaffold when used in breast surgery. Outcomes included ptosis correction and maintenance, associated adverse events, patient and surgeon satisfaction, and mammographic and ultrasound imaging evaluation. RESULTS: At 6 centers in the US, 62 of 69 enrolled patients were treated. Of this population, 89.7% had successful ptosis correction and maintenance at 1 year, with high patient and surgeon satisfaction for breast shape, droop/sag of the breast, and maintenance of results at 1 year. There were 5 adverse events deemed related to the device (8.0%), including nerve pain, breast swelling, ptosis, and 2 instances of asymmetry. CONCLUSIONS: GalaFLEX scaffold safely and successfully supports and elevates breast tissue in mastopexy and reduction mammaplasty, with maintained support at 1 year. Surgeon and patient satisfaction were high. No mammogram or ultrasound interference was detected.

A Multicenter, Prospective, Randomized, Contralateral Study of Tissue Liquefaction Liposuction vs Suction-Assisted Liposuction.

BACKGROUND: Tissue liquefaction liposuction (TLL) deploys a novel energy source utilizing a stream of warmed, low-pressurized, and pulsed saline to extract fat tissue. OBJECTIVES: Compare TLL to suction-assisted liposuction (SAL) to determine which device is more efficient for surgeons and provides better recovery for patients. METHODS: Thirty-one adult female patients were followed prospectively in a contralateral study design comparing differences in bruising, swelling, tenderness, and incision appearance ratings between TLL and SAL procedures. Surgical efficiency and appearance of the lipoaspirate were also compared. RESULTS: All 31 patients successfully completed the study. For TLL and SAL procedures, the average volumes of infusion (1.242 vs 1.276 L) and aspirated supernatant fat (704 vs 649 mL) were statistically similar. TLL median fat extraction rate was faster than SAL (35.6 vs 25 mL/min; P < 0.0001), and stroke rate was reduced in TLL vs SAL procedures (48 vs 120 strokes/min; P < 0.0001), and both were statistically significant. The mean total scores for bruising, swelling, treatment site tenderness, and incision appearance were lower, indicating improved patient recovery on the TLL side. CONCLUSIONS: TLL and SAL techniques produced comparable volume of fat aspirate. TLL demonstrated a 42% faster fat extraction rate and a 68% reduction in arm movements needed to complete the procedure compared to SAL, both of these differences are statistically significant. The TLL side was noted to have reduced bruising and swelling and improved incision site appearance with less tenderness compared to the SAL side.

Clinical Use of GalaFLEX in Facial and Breast Cosmetic Plastic Surgery.

Resolution of ptosis is a key step to the success of many plastic surgery procedures. Ptosis is a manifestation of tissue stretch. Tissue stretch can occur as a result of the natural aging process or health of the patient, or tissue may stretch under added weight or volume, such as when implants are placed. Surgical rejuvenation of ptotic tissues is very effective and results in marked changes in the patient profile yet the tissue that resulted in the need for the procedure first place has not improved and ptosis can recur. Recent developments in long-term resorbable porous materials have provided surgeons with the opportunity to experiment with tissue reinforcement in plastic surgery procedures. These new materials have a low profile, rapid tissue integration, and a long-term strength retention profile. Long-term resorbable scaffolds such as poly-4-hydroxybutyrate (P4HB) natural scaffold (GalaFLEX scaffold, Galatea Surgical, Inc., Lexington, MA) have shown promise for a host of plastic surgery indications. This article presents clinical experience with GalaFLEX for soft tissue reinforcement in three different clinical applications; including the reinforcement of the superficial muscular aponeurotic system (SMAS) in minimally invasive facelift, reinforcement of the skin envelope in mastopexy, and reinforcement of the breast capsule (pocket) in revisional breast surgery. Soft tissue reinforcement has been shown to provide increased mechanical strength as well as improved maintenance of postoperative results. LEVEL OF EVIDENCE: 5 Therapeutic.

Biomarkers Provide Clues to Early Events in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma.

Almost 200 women worldwide have been diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The unique location and specific lymphoma type strongly suggest an etio-pathologic link between breast implants and BIA-ALCL. It is postulated that chronic inflammation via bacterial infection may be an etiological factor. BIA-ALCL resembles primary cutaneous ALCL (pcALCL) in morphology, activated T-cell phenotype, and indolent clinical course. Gene expression array analysis, flow cytometry, and immunohistochemistry were used to study pcALCL and BIA-ALCL cell lines. Clinical samples were also studied to characterize transcription factor and cytokine profiles of tumor cells and surrounding lymphocytes. BIA-ALCL and pcALCL were found to have common expression of transcription factors SOCS3, JunB, SATB1, and a cytokine profile suggestive of a Th1 phenotype. Similar patterns were observed in a CD30+ cutaneous lymphoproliferative disorder (LPD). The patterns of cytokine and transcription factor expression suggest that BIA-ALCL is likely to arise from chronic bacterial antigen stimulation of T-cells. Further analysis of cytokine and transcription factor profiles may allow early detection and treatment of BIA-ALCL leading to better prognosis and survival. LEVEL OF EVIDENCE 5: Risk.

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.

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.