Pharmacokinetics and tissue penetration of vancomycin in patients undergoing prosthetic mammary surgery. (1/29)

Vancomycin concentrations in periprosthetic breast tissues were evaluated in 24 women undergoing reconstructive surgery after mastectomy for breast cancer. Patients were given a single prophylactic dose of vancomycin (1 g iv) 1-8 h before surgery, and mean capsular and pericapsular tissue concentrations were measured by HPLC. Vancomycin was not detectable in the majority of patients belonging to the 1-3 h post-dose groups, whereas in the 4-8 h post-dose groups, mean capsular and pericapsular concentrations were as follows: at 4 h, 4.0 mg/kg and 5.9 mg/kg; at 6 h, 4.1 mg/kg and 4. 8 mg/kg; at 8 h, 5.9 mg/kg and 11.1 mg/kg, respectively. Vancomycin tissue concentrations thus were equal to or exceeded the breakpoint of 4 mg/L in most samples collected 4-8 h after dosing. In conclusion, our data suggest that appropriate timing of vancomycin prophylaxis should be considered to allow the maintenance of adequate tissue concentrations throughout the surgical procedure.  (+info)

Silicone breast implants: lessons from a saga. (2/29)

In the following eleven lessons learned from the silicone breast implant saga in the United States are listed. Some Lessons From The Saga Of Silicone Breast Implants In The U.S. 1. The intrinsic differences between science and the law mean that there will continue to be tension at the interface between the two. 2. Weak scientific evidence makes for weak scientific, clinical and legal judgments. 3. Health policy can influence the weighing of evidence as did the FDA ban on gel filled silicone breast implants in 1992. 4. As the probative value of scientific evidence decreases (that is, the quality and relevance of the evidence) the courts have increasing difficulty in evaluation. 5. Weak scientific evidence along with poor legal judgments can distort clinical understanding and result in harm to patients. 6. Widely publicized speculation and litigation can obscure less dramatic but frequent and serious complications. 7. Clinicans, toxicologists, industry and regulators should maintain surveillance of medical devices, in representative groups if not in all recipients of the devices. 8. The precise identity and composition of each medical device implanted into a person should be recorded both by the manufacturer and in the health care record. 9. The factual basis for informed consent should be vetted by a disinterested party. 10. Patients, clinicians and industry all have a strong interest in assuring the safety of medical devices through regulation. 11. The criteria and process for evaluating the admissibility of scientific evidence in legal proceedings have been improved but universal adoption of the improvements has not been accomplished and further changes may be necessary.  (+info)

Stage of breast cancer at diagnosis among women with cosmetic breast implants. (3/29)

Concern has been raised about the potential delay in breast cancer diagnosis in the augmented breast. We linked a cohort of 2955 women, who received cosmetic breast implants in Denmark during the period 1973-1997 with the Danish Cancer Registry and the Danish Breast Cancer Cooperative Group register. We identified 23 incident cases of invasive breast cancer diagnosed subsequent to breast implantation. We randomly selected 11 controls for each case from the Danish Breast Cancer Cooperative Group's register, and obtained detailed information on all study subjects about surgery, histopathology and stage of breast cancer at diagnosis, intended adjuvant treatment according to trial protocols and overall survival. We found that women with breast implants on average were diagnosed with breast cancer at the same stage as controls. Significantly more women with breast implants had tumour cells in the surgical margins according to the Danish Breast Cancer Cooperative Group's data. There was no significant difference in overall survival between the two groups after an average of 6.4 years of follow-up. Based on this limited number of women with breast cancer subsequent to breast augmentation, breast implants do not appear to delay the diagnosis of breast cancer, and no evidence of impaired survival after breast cancer diagnosis in augmented women was found.  (+info)

Do breast implants after a mastectomy affect subsequent prognosis and survival? (4/29)

In a large study, published in this issue of Breast Cancer Research, Le and colleagues report that women receiving implants after mastectomies for early-stage breast cancer experience lower breast cancer mortality than women not receiving implants. Assessment of survival patterns among women receiving reconstructive implants is complex given unique patient characteristics, disease attributes, and treatment patterns. The interpretation of reduced mortality from breast cancer must be assessed in light of significantly reduced risks of death from most other causes. In contrast, patients receiving post-mastectomy implants had elevated rates of suicide, consistent with findings among women with cosmetic implants. Additional well-designed investigations are needed to clarify survival patterns among women receiving reconstructive implants.  (+info)

Mortality among Canadian women with cosmetic breast implants. (5/29)

There is widespread concern about possible long-term health effects among women who have received breast implants for cosmetic purposes; few studies have reported on the mortality patterns of such women. The authors examined cause-specific mortality in a cohort of 24,558 women with breast implants and 15,893 women who underwent other plastic surgery procedures in Ontario and Quebec, Canada, between 1974 and 1989. Deaths through 1997 were identified through linkage to the national mortality database. The authors compared the mortality of women who received implants with that of the general population by using standardized mortality ratios; Poisson regression was used to perform internal cohort comparisons. Overall mortality was lower among women who received breast implants relative to the general population (standardized mortality ratio = 0.74, 95% confidence interval: 0.68, 0.81). In contrast, higher suicide rates were observed in both the implant (standardized mortality ratio = 1.73, 95% confidence interval: 1.31, 2.24) and other plastic surgery (standardized mortality ratio = 1.55, 95% confidence interval: 1.07, 2.18) patients. No differences in mortality were found between the implant and other surgeries group for any of the 20 causes of death examined. Findings suggest that breast implants do not directly increase mortality in women. Further work is needed to evaluate risk factors for suicide among women who undergo elective cosmetic surgery.  (+info)

Delayed fungal infection following augmentation mammoplasty in an immunocompetent host. (6/29)

We report an unusual case of infection of a breast implant with Trichosporon spp. in an immunocompetent host. There has only been one other reported case in the published literature. The patient was a healthy 27-year-old woman who presented with pain and swelling 17 months after augmentation mammoplasty with a saline implant. Ultrasound-guided aspiration of the effusion surrounding the implant yielded Trichosporon spp. on culture. Oral therapy with fluconazole was commenced, and the implant was salvaged. The nature of this fungi, its mode of transmission and treatment are reviewed. The implications and management of implant infections are also discussed. Physicians should be aware that infection may be delayed, and cultures should be performed for aerobic and anaerobic organisms as well as acid-fast bacilli and fungi. Prompt and appropriate antimicrobial treatment may arrest the infection, sparing the patient the morbidity of a surgical drainage or implant removal.  (+info)

Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. (7/29)

BACKGROUND: Lipoinjection is a promising treatment but has some problems, such as unpredictability and a low rate of graft survival due to partial necrosis. METHODS: To overcome the problems with lipoinjection, the authors developed a novel strategy known as cell-assisted lipotransfer (CAL). In CAL, autologous adipose-derived stem (stromal) cells (ASCs) are used in combination with lipoinjection. A stromal vascular fraction (SVF) containing ASCs is freshly isolated from half of the aspirated fat and recombined with the other half. This process converts relatively ASC-poor aspirated fat to ASC-rich fat. This report presents the findings for 40 patients who underwent CAL for cosmetic breast augmentation. RESULTS: Final breast volume showed augmentation by 100 to 200 ml after a mean fat amount of 270 ml was injected. Postoperative atrophy of injected fat was minimal and did not change substantially after 2 months. Cyst formation or microcalcification was detected in four patients. Almost all the patients were satisfied with the soft and natural-appearing augmentation. CONCLUSIONS: The preliminary results suggest that CAL is effective and safe for soft tissue augmentation and superior to conventional lipoinjection. Additional study is necessary to evaluate the efficacy of this technique further.  (+info)

Antibiotic therapy of transaxillary augmentation mammoplasty. (8/29)

BACKGROUND: Capsular contracture is the most common complication and the main cause of dissatisfaction after augmentation mammoplasty, for both the patient and the plastic surgeon. The formation of fibrous tissue around the prosthesis alters the form or the consistency of the implant, thus modifying the breast shape, its contour and its softness. The initial satisfaction with the achieved aesthetical result is then transformed into great dissatisfaction, due to the presence of a shapeless and undesired mass. PATIENTS AND METHODS: The following study considered data collected between 1998 and 2007. Sixty-seven female patients (aged between 35 and 53 years) who suffered from mammary hypotrophy and had undergone submuscular augmentation mammoplasty were enrolled. All the implanted prostheses were round and texturized, with a volume of 250 cm3 to 450 cm3. The patients underwent pre-, intra- and postoperative antibiotic therapy in order to prevent clinical and subclinical infection of the implants. RESULTS: The follow-up ranged from a period of two to nine years. All patients were examined during the first antibiotic administration and again subsequently, after 1, 3, 6 and 12 months, to evaluate the results in terms of capsular contracture. Of all patients, 90% presented a degree I Baker's classification, the remaining 10% a degree II. Not one of the patients treated showed grade III or IV capsular contracture nor was there any need to remove the prosthesis during the examination period. CONCLUSION: It is clear that a main role in capsular contracture is played by the infectious process, with the activation of specific inflammatory cells. Interfering with the infectious process can prevent fibrotic reaction evolving into capsular contracture. Although the process causing capsular contracture is multifactorial, our study showed a favourable response can be achieved when using antibiotic therapy associated with the transaxillary approach.  (+info)