The American Journal of Cosmetic Surgery

In 2000, Florida mandated that all physicians report all adverse events occurring in an office setting to a central collecting agency. The purpose here is to analyze the scope and incidence of adverse events and deaths resulting from office surgical procedures in Florida from 2000 to 2005.

All reported adverse incidents (eg, the death of a patient or ahospital transfer) occurring after an office procedure as reported to the Florida Agency for Health Care Administration from March 1, 2000, through March 1, 2005, were reviewed. Additional information was gained via telephone follow-up and Internet searches.

Of 351 reported office adverse events, 110 occurred in association with an office surgical procedure—25 deaths and 85 hospital transfers. Thirteen complications and 5 deaths were clearly associated with use of intravenous sedation anesthesia or general anesthesia. Two deaths and 11 complications were at the hands of anesthesiologists with an MD or DO credential, 2 deaths were attributable to plastic surgeons using intravenous sedation, and 1 death and 2 hospital transfers were attributable to certified registered nurse anesthetists administering anesthesia. No adverse events were associated with use of dilute local (tumescent) anesthesia.

Dermatologists are currently under scrutiny by legislative and regulatory bodies because they perform liposuction under tumescent local anesthesia in an office setting. But the data from Florida, presented here and elsewhere, clearly show that dermatologists are not the problem. An extraordinarily high percentage of cosmetic surgery deaths and hospital transfers were attributable to board-certified plastic surgeons. A fair analysis of the data indicates that any restrictions on office procedures should start with the specialty demonstrating the most adverse events. State and/or national legislation establishing reporting systems for adverse events should be supported and should require the reporting of delayed deaths. Restrictions on dilute local (tumescent) anesthesia for liposuction would not reduce adverse events and could increase them if patients are forced into liposuction under deeper anesthesia.

Calcium hydroxyapatite (CaHa; also spelled “hydroxylapatite”) is the main mineral component of bone, calcified cartilage, and teeth. It has been used since the 1970s in many specialties, including orthopedics, urology, otolaryngology, maxillofacial surgery, and radiology, as a bioactive implant that promotes chemical attachment of the soft tissue to its surface. In 2001, Radiance FN (now Radiesse) was introduced as a CaHa-based product and approved by the US Food and Drug Administration (FDA) as a radiographic tissue marker, for soft tissue vocal fold augmentation, and for implants in maxillofacial defects. Currently, it is also used outside the United States and off-label in the United States for facial soft tissue augmentation. Microspheres of CaHa are suspended in a mixture of water, glycerin, and carboxymethylcellulose gel that provides a scaffold for tissue infiltration. Once injected, the gel is degraded and the CaHa infiltrates the surrounding cells. CaHa is nonirritating, and the carrier gel components are classified as safe by the FDA. Although a great variety of fillers are currently on the market, CaHa (Radiesse) has demonstrated the longest duration in tissue without any reports of antigenicity, migration, or granuloma formation. In this study, we report our experience with CaHa (Radiesse) for aesthetic soft tissue augmentation.

A total of 139 patients were treated over an 18-month period at 2 private offices in Argentina and the United States. Exclusion criteria included previous use of permanent tissue fillers in the treatment area. Patients with previous use of hyaluronic acid fillers in the treatment area (up to 1 year prior to the study) were allowed to participate in the study. Radiesse was injected from 1-mL prefilled syringes with 27½-gauge needles in different areas such as nasolabial folds, lips, marionettes lines, cheeks, and cellulite dimples. Patient satisfaction and adverse effects were assessed by both physicians and patients during the procedure and during follow-up visits up to 1 year later.

Minimal pain, erythema, edema, and bruising were noted during and immediately after the procedure. All of the patients treated were satisfied with their results after one visit. There were no long-term adverse effects during the study period or on follow-up visits. Evaluation of 75% of the patients 1 year after treatment revealed persistence of filling effects.

CaHa used for aesthetic soft tissue augmentation yields immediate clinical results with high patient satisfaction.

Nasal obstruction secondary to internal nasal valve (INV) collapse is a well-described condition. Symptoms of INV collapse include chronic nasal congestion, nasal airway obstruction, snoring, and difficulty obtaining restful sleep. The authors report the use of calcium hydroxylapatite (CaHA) injection as a spreader graft to improve nasal airway patency in patients experiencing INV collapse.

Of 12 patients enrolled in the study, 6 patients completed follow-up and are the subject of this report. They were evaluated and found to have bilateral INV collapse resulting in nasal obstruction. A total of 12 sides were injected with small aliquots of CaHA, also known as Radiesse. Injections were directed into the INV at the junction of the upper lateral cartilage and the dorsal septum until nasal obstruction was relieved and INV angles were visually increased. Biopsy of the CaHA spreader graft was undertaken for histologic evaluation in 1 patient who underwent elective cosmetic rhinoplasty. Each patient completed subjective nasal airway patency questionnaires documenting their degree of perceived nasal obstruction before the CaHA spreader graft and at the 3-month follow-up.

All 6 patients experienced immediate subjective relief of their nasal obstruction with the CaHA spreader graft. Immediate posttreatment INV angles were visually widened at rest and during inspiration. At the 3-month follow-up, the improvement in the INV angles remained for all 6 patients. In addition, the subjective nasal airway patency evaluations universally correlated with the observed changes, and high patient satisfaction was preserved. Histologic findings for 1 patient revealed fibrous tissue with few foreign body giant cells.

Use of CaHA spreader graft injection to relieve nasal obstruction because of INV collapse appears to be a reasonable nonsurgical alternative. Long-term studies are ongoing.

Autologous fat theoretically provides one of the most ideal mediums for soft-tissue augmentation and reconstruction, although its clinical applications have been marked with skepticism because of its documented unreliable survival. Over the years, numerous unsuccessful efforts have set forth to elucidate modifications in the application process of autologous fat grafts to allow the medium greater clinical predictability. This study aims to investigate the effects of platelet-rich plasma (PRP) on autologous fat grafts when used in conjunction with each other in soft tissue augmentation and reconstruction.

Retrospective review, over a 30-month period, of consecutive patients with results greater than 6 months in duration.

This study is based on clinical experiences representing 2033 grafts in 448 consecutive patients using PRP additives and in the previous 132 patients who had syringe harvest without use of PRP. All PRP isolates were harvested via the Smart Prep system. Harvest and augmentation techniques are discussed and representative results are presented.

Results were based on clinical observations and patient satisfaction. Of the 580 patients in the experimental group, essentially all showed greater graft volume retention over extended time intervals compared with control subjects (nongraft areas). Patients in the PRP-added experimental group displayed less postoperative ecchymosis and edema, which also led to greater patient satisfaction in this group.

Adding PRP to autologous fat aids in graft volume retention and survival when used clinically for soft-tissue augmentation and reconstruction.