Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device. Final order.

The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; General and Plastic Surgery Devices; Classification of the Microneedling Device for Aesthetic Use. Final order.

The Food and Drug Administration (FDA or we) is classifying the microneedling device for aesthetic use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the microneedling device for aesthetic use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; General and Plastic Surgery Devices; Classification of the Irrigating Wound Retractor Device. Final order.

The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the irrigating wound retractor device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order.

The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use. Final order.

The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker. Final order.

The Food and Drug Administration (FDA) is classifying the internal tissue marker into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the internal tissue marker's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical devices; general and plastic surgery devices; classification of the powered surgical instrument for improvement in the appearance of cellulite. Final order.

The Food and Drug Administration (FDA) is classifying the powered surgical instrument for improvement in the appearance of cellulite into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The differential impact of plastic surgery subspecialties on the financial performance of an academic clinical practice.

BACKGROUND: In an academic center, plastic surgery provides multiple important and distinct services. Limited data exist on how each service affects a department clinically and financially. METHODS: All new patient consultations and surgical cases between 2004 and 2012 were reviewed. Conversion rates from consultation to surgery and relative value units were calculated. Professional and facility revenues, costs, and net income were ascertained. These measures were compared between different subspecialties. RESULTS: A total of 12,020 new patient consultations and 5741 surgical cases were reviewed. Total growth in consultations was greatest for breast reconstruction (396.8 percent), followed by aesthetic (83.8 percent), oncology (12.9 percent), general (-16.9 percent), and burn/trauma (-75.0 percent). The conversion rate from consultation to surgery was highest in breast reconstruction (57.0 ± 3.1 percent) and oncology (56.9 ± 6.6 percent), followed by burn/trauma (47.0 ± 6.8 percent), general (46.1 ± 3.5 percent), and aesthetic (37.0 ± 4.8 percent). Total growth in professional net income was greatest for breast reconstruction (1241.4 percent), followed by oncology (378.4 percent), general (159.7 percent), aesthetic (130.5 percent), and burn/trauma (-20.9 percent). Total growth in facility net income was greatest for breast reconstruction (7619.5 percent), followed by oncology (2648.0 percent), aesthetic (432.3 percent), general (283.3 percent), and burn/trauma (108.7 percent). CONCLUSIONS: Breast reconstruction exhibited the greatest growth in consultations, and oncologic consultations demonstrated the highest consultation-to-surgery conversion rate. The higher consultation volume and conversion rate associated with breast reconstruction resulted in greater financial gains for both the department and the hospital. These findings may be of utility in the development of academic plastic surgery programs.

The advent of the restorative plastic surgeon.

Plastic surgery is presently typified by the existence of discrete clinical identities, namely that of the cosmetic plastic surgeon and the reconstructive plastic surgeon. The emergence of vascularized composite allotransplantation has been accompanied by the development of a third distinct clinical identity, that of the restorative plastic surgeon. The authors describe the core competencies that characterize this new identity, and discuss the implications of the advent of this new professional paradigm.

Oral and maxillofacial surgery - a case of mistaken identity?

There are international grumbles from those perturbed by an impending identity crisis within oral and maxillofacial surgery (OMFS). This unrest is further compounded by scattered suggestions that a name change may prove beneficial in raising the profile of OMFS. The purpose of this paper is to consider novel methods of increasing awareness of the specialty amongst the public, primary and secondary care colleagues by collecting a consensus of thoughts and opinions regarding the specialty's identity and the appropriate and holistic nomenclature of OMFS. Approximately 300 eight-point questionnaires were distributed internationally with a response rate, via both email and post, of approximately 25% (72). Thirty-two percent of respondents considered there to be an identity crisis within OMFS although just 18% felt that a specialty name change would be beneficial. The results suggest that the problem with identity relates more to incapacity to convey the message of OMFS rather than nomenclature.

Diagnosis and management of skin resurfacing-related complications.

The field of skin resurfacing is undergoing rapid evolution with many new technologies that have developed, providing more choices for physicians and patients. Knowing the potential adverse effects associated with each skin resurfacing modality is paramount in selecting the appropriate approach for each candidate, thereby minimizing complications and achieving optimal results.

Complications in fillers and Botox.

Americans spent $11 billion on cosmetic surgery procedures in 2007. Almost $3 billion were spent on minimally invasive procedures, of which injectable facial fillers and botulinum toxin type A (Botox) were the most popular. Injectables have fueled the fires of the popularity of cosmetic facial surgery. They have provided more options to patients and surgeons and provided quick, affordable, predictable, and long-lasting improvement of facial wrinkles and lip augmentation. Even in sour economies, patients want to look good and although they may not have money to spend on surgical procedures, injectable treatments remain popular. This article addresses common complications of injectable fillers and Botox.

Nerve injuries and treatment in facial cosmetic surgery.

Surgical intervention remains a popular choice in patients seeking facial rejuvenation. Although uncommon, temporary or permanent peripheral nerve injury may complicate almost any type of invasive aesthetic procedure of the face, resulting in functional and psychological consequences for patients. Prompt recognition and appropriate intervention are necessary to avoid the long-term sequelae and improve the chances of complete neurologic recovery. Depending on the type of injury, various interventions may range from observation and close follow-up to interposition nerve grafting. This article reviews the pertinent anatomy of nerves at risk in facial cosmetic surgery and discusses various management strategies for inadvertent injury to peripheral nerves of the face.

How to avoid blepharoplasty complications.

Complications unfortunately are part of blepharoplasty surgery. The goal of this article is to help guide the surgeon through the thought process of the preoperative evaluation, surgical planning, and actual surgery to avoid complications. With better understanding of the goals of blepharoplasty and the areas for potential problems, we hope to reduce the possibility of developing complications.

Complications of neck liposuction and submentoplasty.

Patients desiring improved neck and jawline contours often are looking for minimally invasive procedures and are not interested in undergoing extensive face-lifting procedures. Realizing the limitations, surgeons may offer their patient such procedures as liposuction and submentoplasty. Even though these procedures are less involved than a facelift, many pitfalls can occur, leading to an unfavorable result and a disappointed patient. Proper patient selection and choosing the correct operation are crucial to avoiding these situations. This article focuses on the common complications of neck liposuction and submentoplasty and reviews the management and avoidance of these complications.

Complications following fat transfer.

Traditionally, strategies for facial rejuvenation have emphasized correction of tissue ptosis and laxity with suspensory and excisional techniques, such as face-lifting and blepharoplasty. Volume loss plays a significant role in facial aging and, until recently, had not received appropriate attention. Facial fat grafting to correct volume loss has become a crucial component of facial rejuvenation in the authors' respective practices.

Complications in facelift surgery and their prevention.

The purpose of this article is to discuss the pros and cons of various aspects of rhytidectomy surgery. The author presents his experiences that have led to performing approximately 85 facelifts a year and what has proved beneficial along the way over the past decade in his cosmetic facial practice. Because it is impossible to incorporate all aspects of facelift complications into the confines of this article, the author focuses on some of the more common problematic and avoidable complications.

Complications of rhinoplasty.

Rhinoplasty presents a unique set of challenges for the cosmetic surgeon. Complications may arise from inadequate diagnosis, errors in surgical technique, or variations in the patient's anatomy or healing response. Complications as a result of overly aggressive surgery may also have functional consequences and be harder to correct.