Breast Implants: Protocol for Retrieval and Analysis.

The Center for Implant Retrieval and Analysis has been established at Washington University's Division of Plastic and Reconstructive Surgery for the purpose of studying implantable devices retrieved after surgery or autopsy and assessing their condition after implantation. Since the early 1990s, significant experience has been gained in testing and analyzing silicone gel breast implants and, to a lesser extent, saline-filled devices. However, there has been no systematic method reported for collecting and evaluating these implants in a way that would permit di. erent laboratories to compare their data. This article offers the plastic and reconstructive surgery community a standardized protocol for analyzing explanted silicone gel and saline-filled breast implants. The protocol gives surgeons a clearly defined approach for removing, handling, documenting, and shipping explanted breast implants. At the same time, biomaterials researchers can use the protocol to acquire implant data with reliable and reproducible methods. Because the study of saline implants has lagged behind the study of silicone gel implants, the article concludes with a demonstration of how this protocol can be applied to obtain mechanical properties data and use scanning electron microscopy to illuminate failure mechanisms of saline devices, including three explants removed after 20+ years in vivo.

Management of contaminated autologous grafts in plastic surgery.

BACKGROUND: Contamination of autologous grafts unfortunately occurs in plastic surgery, but the literature provides no guidance for management of such incidents. METHODS: American Society of Aesthetic Plastic Surgery members were asked to complete an online survey that asked about the number and causes of graft contaminations experienced, how surgeons dealt with the problem, the clinical outcomes, and patient disclosure. RESULTS: Nineteen hundred surgeons were asked to participate in the survey, and 223 responded. Of these, 70% had experienced at least 1 graft contamination incident, with 26% experiencing 4 or more. The most frequently reported reason for graft contamination was a graft falling on the floor (reported by 75%). Nearly two thirds of the contaminated grafts related to craniofacial procedures. Ninety-four percent of grafts were managed with decontamination and completion of the operation. The most common method of decontamination was washing with povidone-iodine, but this practice is contrary to recommendations in the literature. Only 3 surgeons (1.9%) said a clinical infection developed following decontaminated graft use. Patients were not informed in 60% of graft contamination incidents. The survey results and review of the literature led to development of algorithms for the management of inadvertent graft contamination and patient disclosure. CONCLUSIONS: Although autologous grafts do become contaminated in plastic surgery, the overwhelming majority can be safely decontaminated and produce minimal or no clinical sequelae. The algorithms presented are intended to serve as guides for prevention of contamination events or for their management should they occur.

The need for venous thromboembolism (VTE) prophylaxis in plastic surgery.

LEARNING OBJECTIVES: The reader is presumed to have a broad understanding of plastic surgical procedures and concepts. After studying this article, the participant should be able to: Physicians may earn 1 AMA PRA Category 1 credit credit by successfully completing the examination based on material covered in this article. The examination begins on page 176. ASAPS members can also complete this CME examination online by logging onto the ASAPS Members-Only Web site (http://www.surgery.org/members) and clicking on "Clinical Education" in the menu bar. Little has been published about venous thromboembolism (VTE) complications in plastic surgery. The authors investigated the recent literature, particularly literature reviews and meta-analyses of clinical studies, in order to outline strategies for prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) applicable to plastic surgery patients. Major risk factors for VTE include trauma, a prior history of VTE, older age, use of oral contraceptives or hormone replacement therapy, and prolonged travel. Although the frequency of VTE among plastic surgery patients is estimated to be from less than 1% to 2% of cases, in fact many of our patients are at moderate to high risk of VTE. Moreover, the actual frequency of VTE among plastic surgery patients is probably higher than we know, because up to two thirds of cases are asymptomatic. Mechanical methods of VTE prophylaxis include graduated compression stockings (GCSs), intermittent pneumatic compression (IPC) devices, and venous foot pumps (VFPs). They are recommended primarily for patients with a high risk of bleeding or as an adjunct to chemoprophylaxis. Intermittent pneumatic compression devices were found to be more effective than passive compression using GCSs. For plastic surgery patients, IPC devices or VFPs are recommended for any procedure that lasts more than 1 hour, and for all patients receiving general anesthesia. Use should begin 30 to 60 minutes before surgery. Low-molecular-weight heparin (LMWH) is the most widely used form of DVT/PE prophylaxis. Other forms of chemoprophylaxis are coming onto the market or under development. In particular, fondaparinux, an indirect FXa inhibitor, was approved in 2004 for VTE prophylaxis in orthopedic surgery. Studies have indicated that it is significantly more effective than LMWH after joint replacement, hip fracture surgery, and in cancer patients. Other drugs in development include idraparinux, another indirect FXa inhibitor, direct FXa inhibitors, and several direct thrombin inhibitors. Plastic surgeons have generally been reluctant to use antithrombotic agents because of the increased risk of bruising or hematoma and the possible need for blood transfusion. However, numerous studies have found little or no increase in the frequency of clinically important bleeding associated with their use. Some plastic surgeons now routinely use chemoprophylaxis in patients undergoing abdominoplasty, combined procedures, or procedures lasting more than 4 hours. The authors also recommend postoperative chemoprophylaxis in circumferential body contouring, thighplasty, surgery requiring open space dissection, transverse rectus abdominus muscle (TRAM) procedures, and surgical procedures likely to contribute to venous stasis or compression. It is impractical and expensive to screen every patient for asymptomatic DVT. A patient history focusing specifically on VTE risk factors should be performed within a few weeks of surgery. Patient education should include information about the symptoms of DVT and PE (including the fact that most patients with VTE are asymptomatic) and a full explanation of the risks and benefits of anticoagulant prophylaxis.

Prevention of perioperative hypothermia in plastic surgery.

While inadvertent perioperative hypothermia has received serious attention in many surgical specialties, few discussions of hypothermia have been published in the plastic surgery literature. This article reviews the physiology of thermoregulation, describes how both general and regional anesthesia alter the normal thermoregulatory mechanisms, indicates risk factors particularly associated with hypothermia, and discusses the most effective current methods for maintaining normothermia. Hypothermia is typically defined as a core body temperature of /=36.5 degrees C is maintained. Unless preventive measures are instituted, inadvertent hypothermia occurs in 50% to 90% of surgical patients, even those undergoing relatively short procedures lasting one to one-and-a-half hours. During either general or regional anesthesia, a patient's natural behavioral and autonomic responses to cold are unavailable or impaired, and the combination of general and neuraxial anesthesia produces the highest risk for inadvertent perioperative hypothermia. Unless hypothermia is prevented, the restoration of normothermia can take more than 4 hours once anesthesia is stopped. Consequences of hypothermia are serious and affect surgical outcomes in plastic surgery patients. Potential complications include morbid cardiac events, coagulation disorders and blood loss, increased incidence of surgical wound infection, postoperative shivering, longer hospital stays, and increased costs associated with surgery. Measures for preventing hypothermia are emphasized in this article, especially those proven most effective in prospective and controlled clinical studies. Perhaps the most important step in maintaining normothermia is to prewarm patients in the preoperative area with forced-air heating systems. Intraoperative warming with forced-air and fluid warming are also essential. Other strategies include maintaining an ambient operating room temperature of approximately 73 degrees F (22.8 degrees C), covering as much of the body surface as possible, and aggressively treating postoperative shivering. None of these measures can be adequately employed unless a patient's core body temperature is monitored throughout the perioperative period. Prevention of perioperative hypothermia is neither difficult nor expensive. Proper preventive measures can reduce the risk of complications and adverse outcomes, and eliminate hours of needless pain and misery for our patients.

DMSO: applications in plastic surgery.

The authors point out that dimethyl sulfoxide (DMSO) increases tissue perfusion and may effectively treat or prevent ischemia in flaps. They recommend application of topical DMSO every 4 to 6 hours, until blood flow improves, to areas that show signs of ischemia or less than adequate perfusion. Other potential cosmetic surgery uses of DMSO include areas of skin care, pain relief, and treatment of keloids.

Initial results from an online breast augmentation survey.

BACKGROUND: Data have been lacking to answer many questions raised in the clinical literature and by the US Food and Drug Administration with regard to patient satisfaction with breast implants, informed consent, the impact of augmentation on quality of life, repeat operations, and other issues related to breast augmentation. OBJECTIVE: The authors conducted an online survey of women with and without breast implants to collect data on key issues related to breast augmentation. METHODS: A survey including 177 questions was posted on the Web site www.implantinfo.com for 6 months, from August 2001 to February 2002. The survey was aimed at women who had undergone augmentation and those who were considering augmentation but had not yet undergone surgery. The raw data were analyzed by Data Harbor (Chicago, IL), an independent data management and technology development company with experience in managing large, complex medical databases. RESULTS: The survey was completed by 4011 women, including 2273 who had received breast implants and 1738 who were considering augmentation. Among the key findings: More than half of the women who had undergone breast augmentation and those who were considering the procedure thought about the decision for at least 3 years before proceeding. Most women who underwent breast augmentation (88%) were satisfied with the results, and 93% said they would recommend the procedure to friends or family members. Nearly all women who received implants thought the surgery improved their overall appearance (92%) and self-confidence (82%) but said it did not result in significant changes in their marriage/dating activities, careers, or social lives. At least 92% said their surgeons had answered their questions and listened to their concerns, and more than 75% said they remembered being informed of the risks of surgery. The percentage of women with breast pain was greater among women with implants than among those without. However, other physical symptoms, such as those associated with rheumatologic diseases, were more common among women considering augmentation. Respondents with implants did not smoke at levels higher than comparable women in the general population and were not major consumers of alcohol. CONCLUSIONS: The Online Breast Augmentation Survey provides a wealth of previously unavailable data on women who have undergone or who are considering breast augmentation. The data indicate that women consider breast augmentation carefully, that they are well informed by their physicians before surgery, and that they are generally happy with the results.

Protocol for retrieval and analysis of breast implants.

The Center for Implant Retrieval and Analysis has been established at Washington University's Division of Plastic and Reconstructive Surgery for the purpose of studying implantable devices retrieved after surgery or autopsy and assessing their condition after implantation. Since the early 1990s, significant experience has been gained in testing and analyzing silicone gel breast implants and, to a lesser extent, saline-filled devices. However, there has been no systematic method reported for collecting and evaluating these implants in a way that would permit different laboratories to compare their data. This article offers the plastic and reconstructive surgery community a standardized protocol for analyzing explanted silicone gel and saline-filled breast implants. The protocol gives surgeons a clearly defined approach for removing, handling, documenting, and shipping explanted breast implants. At the same time, biomaterials researchers can use the protocol to acquire implant data with reliable and reproducible methods. Because the study of saline implants has lagged behind the study of silicone gel implants, the article concludes with a demonstration of how this protocol can be applied to obtain mechanical properties data and use scanning electron microscopy to illuminate failure mechanisms of saline devices, including three explants removed after 20+ years in vivo.

Mechanical analysis of explanted saline-filled breast implants exposed to betadine pocket irrigation.

BACKGROUND: Because of concerns that exposure to povidone-iodine (Betadine) may lead to early breast implant failure, the Food and Drug Administration announced in 2000 that any contact between implants and Betadine is contraindicated. The evidence cited by the Food and Drug Administration primarily referred to Betadine added to saline implant filler solution and not to povidone-iodine used for pocket irrigation. OBJECTIVE: Thirteen explanted Mentor saline solution-filled devices that had been exposed to Betadine pocket irrigation during implantation were studied for any loss of implant shell integrity. METHODS: The 13 explants had been in place 1 week to 55 months, and none had intraluminal Betadine exposure. Twelve of the 13 explants were intact when removed, and one had leaked through the anterior valve. All were examined for any signs of patch-shell delamination. The mechanical properties of tensile strength, percent elongation, force-to-break, tear resistance, and patch bond strength were also measured. RESULTS: No shell delamination or disruption of the sealing patch bond was found in any of the 13 explants placed in Betadine-irrigated pockets. In addition, the measured mechanical properties of the explants exceeded American Society for Testing and Materials requirements, with the exception of the textured explants (n = 2), which failed to meet the minimum elongation standards. CONCLUSIONS: We found no evidence of patch or shell delamination in Mentor implants that had extraluminal contact with Betadine irrigation and were later explanted. We believe that the lower mechanical properties of the two textured implants are probably related to the texturing process rather than to Betadine pocket irritation. (Aesthetic Surg J 2002;22:438-445.).