Surgery News - January 2008 - (Page 23) J A N U A RY 2 0 0 8 • SURGERY NEWS BREAST, SKIN & SOF T TISSUE Breast Reconstruction Yields Long-Term Satisfaction B Y M I C H E L E G. S U L L I VA N Else vier Global Medical Ne ws N E W O R L E A N S — The benefits of breast reconstruction after mastectomy persist into the long-term survivorship period, Dr. Emily Hu reported at the annual clinical congress of the American College of Surgeons. Dr. Hu presented surveys that demonstrated greater emotional and physical well-being in breast cancer survivors who had reconstruction surgery than in those who had mastectomy only. Her cross-sectional surveys also showed that women who underwent transverse rectus abdominis myocutaneous (TRAM) reconstruction more than 8 years ago were more satisfied with the aesthetics of their reconstructed breast than were those who received an expander or implant. Dr. Hu and her colleagues surveyed 391 women who had been treated at the University of Michigan, Ann Arbor, for breast cancer since 1977. While the mean proved sexual function as were their mastectomy-only counterparts. “The psychosocial benefits of breast reconstruction persist into the long-term survivorship period,” Dr. Hu said. “We should continue to recommend reconstruction to patients and work to improve access for all those who desire it.” The investigators also surveyed a group of 228 women who had undergone breast reconstruction since 1977 with either TRAM (117 patients) or expander or implant (111). The groups were stratified into the same three follow-up periods. In the short-term groups, there were no significant differences in overall satisfaction or aesthetic satisfaction (appearance, shape, softness, or projection of the reconstructed breast). In the long-term group, however, significant differences emerged. Compared with survivors who received an expander or implant more than 8 years ago, TRAM patients were 6 times as likely to be satisfied with the appearance of the reconstructed breast, 24 times as likely to be sat- isfied with its shape, and 30 times as likely to be satisfied with its softness. The percent of expander or implant patients satisfied with their aesthetic outcomes also fell significantly from the shortterm to the long-term periods, dropping from 82% to 45% satisfaction with appearance, 71% to 35% satisfaction with shape, and 67% to 35% satisfaction with softness. Conversely, the number of TRAM patients satisfied with these outcomes remained consistent (75%-80%) over all the periods. ■ RECONSTRUCTION PATIENTS WERE MORE LIKELY THAN MASTECTOMY-ONLY PATIENTS TO REPORT IMPROVED EMOTIONAL AND PHYSICAL WELL-BEING. follow-up period was 7 years, it ranged from 3 to 30 years. Most of the group (247) had breast reconstruction surgery, while the rest (144) had only mastectomy. The groups were divided into three survivorship periods: 5 years or less since surgery, 6-8 years since surgery, and more than 8 years since surgery. Women rated their current general quality of life on a scale of 0-100, and their quality of life with regard to their breast surgery on a 1-5 Likert scale. Overall, both groups rated their quality of life as high (84 for the reconstruction group and 82 for the mastectomy-only group). Although there was no significant difference in overall quality of life between the groups, there was a significant difference among the short-term survivors: Those who had reconstruction reported a significantly higher quality of life (88 vs. 81). This difference disappeared over time, however, said Dr. Hu of the plastic surgery department at the university. When the women rated specific quality of life issues with regard to their breast surgery, significant differences emerged over the long term, all of which favored reconstruction. “We asked women to compare their current quality of life in these areas to that which they experienced before their surgery,” Dr. Hu said. “In the long-term group, women who had reconstruction were 4.5 times as likely to report improvement in emotional well-being, and 4 times as likely to report improvement in physical well-being.” These women were also six times as likely to report improved social interaction and eight times as likely to report im- TYGACIL® (tigecycline) Brief Summary See package insert for full Prescribing Information. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. CONTRAINDICATIONS TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline. WARNINGS Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics. TYGACIL may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking tigecycline, the patient should be apprised of the potential hazard to the fetus. Results of animal studies indicate that tigecycline crosses the placenta and is found in fetal tissues. Decreased fetal weights in rats and rabbits (with associated delays in ossification) and fetal loss in rabbits have been observed with tigecycline. (See PRECAUTIONS, Pregnancy.) The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Results of studies in rats with TYGACIL have shown bone discoloration. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS General Caution should be exercised when considering TYGACIL monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation. (See ADVERSE REACTIONS.) In Phase 3 cIAI studies (n=1642), 6 patients treated with TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock. The 6 patients treated with TYGACIL had higher APACHE II scores (median = 13) vs the 2 patients treated with imipenem/cilastatin (APACHE II scores = 4 and 6). Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL. The safety and efficacy of TYGACIL in patients with hospital acquired pneumonia have not been established. In a study of patients with hospital acquired pneumonia, patients were randomized to receive TYGACIL (100 mg initially, then 50 mg every 12 hours) or a comparator. In addition, patients were allowed to receive specified adjunctive therapies. The sub-group of patients with ventilator-associated pneumonia who received TYGACIL had lower cure rates (47.9% versus 70.1% for the clinically evaluable population) and greater mortality (25/131 [19.1%] versus 15/122 [12.3%]) than the comparator. As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken. Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Patients should be counseled that antibacterial drugs including TYGACIL should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When TYGACIL is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by TYGACIL or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with http://www.wyeth.com http://www.wyeth.com
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