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| FDA Approves Silicone Breast Implants
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Ending a 14-year ban on their use in cosmetic surgery, the Food and Drug Administration has granted two California firms its approval to commercially market silicone gel-filled breast implants in the United States.
In a Nov. 17 announcement, the agency notes that its approval of implants produced by Allergan Corp. of Irvine and Mentor Corp. of Santa Barbara is based on a rigorous review of clinical trial data.
"The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices," says Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health, in a statement. "This information is available in the product labeling and will enable women and their physicians to make informed decisions."
Roxanne Guy, MD, president of the American Society of Plastic Surgeons, hailed the agency's approval. "Silicone breast implants have been scrutinized more than any medical device, and we applaud the FDA for making its well thought-out decision and allowing American women to make informed choices about their health care," she says.
Silicone implants have been limited to reconstruction cases and controlled trials since 1992 following concerns that ruptures and leaks led to cancer, lupus and other chronic illnesses among recipients. Since then, breast augmentation procedures have used saline-filled implants exclusively.
While studies conducted over the past decade have cleared silicone gel implants of these safety fears, the FDA's announcement reminds potential patients that they are not without risks. Breast implants are not expected to last the patient's lifetime and future surgeries are to be expected, it explains; the surgery makes irreversible changes to the anatomy of the breast; and implant ruptures may go undetected due to their silence.
To that end, the agency has imposed conditions on the new implants' use. They can be used for reconstruction in women of all ages, but augmentation patients must be more than 22 years old due to breast development; patients are recommended to undergo periodic MRI examinations for the lifespan of the implants to detect ruptures; the manufacturers must conduct 10-year post-approval studies of 40,000 patients to monitor their health and potential complications; and the manufacturers must track implants in order to notify patients of later findings.
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| Single-dose Antibiotic Regimen Effective, Say Researchers
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New research suggests a single dose of antibiotic administered before surgery is as effective as a 24-hour dosing regimen in reducing surgical site infections. The study, published in the November issue of Archives of Surgery, also notes that a single-dose protocol will result in significant savings in antibiotic costs.
Researchers in Brazil gave a single 1g dose of cephazolin during the administration of anesthesia to 6,140 consecutive patients who underwent surgery between December 2002 and August 2003. Surgical site infections occurred in 133 patients, or 2.1 percent of the cohort. Under a 24-hour antibiotic protocol administered to 6,140 consecutive patients between February 2002 and October 2002, surgical site infections occurred in 127 cases, or 2 percent of the group.
The number of cephazolin vials purchased dropped from 1,259 in the 24-hour study group to 467 in the single-dose group. This decrease resulted in a monthly savings of $1,980, according to the study's researchers.
"We were able to demonstrate that one-dose prophylaxis is feasible," write the study's authors. "In this era of restricted hospital budgets and increased bacterial resistance, one-dose prophylaxis may provide a way to improve performance by lowering costs."
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| Is Disk Injury Surgery Necessary?
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New research suggests a single dose of antibiotic administered before surgery is as effective as a 24-hour dosing regimen in reducing surgical site infections. The study, published in the November issue of Archives of Surgery, also notes that a single-dose protocol will result in significant savings in antibiotic costs.
Researchers in Brazil gave a single 1g dose of cephazolin during the administration of anesthesia to 6,140 consecutive patients who underwent surgery between December 2002 and August 2003. Surgical site infections occurred in 133 patients, or 2.1 percent of the cohort. Under a 24-hour antibiotic protocol administered to 6,140 consecutive patients between February 2002 and October 2002, surgical site infections occurred in 127 cases, or 2 percent of the group.
The number of cephazolin vials purchased dropped from 1,259 in the 24-hour study group to 467 in the single-dose group. This decrease resulted in a monthly savings of $1,980, according to the study's researchers.
"We were able to demonstrate that one-dose prophylaxis is feasible," write the study's authors. "In this era of restricted hospital budgets and increased bacterial resistance, one-dose prophylaxis may provide a way to improve performance by lowering costs."
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| News and Notes |
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DISCHARGING TONSILLECTOMY PATIENTS SHORTLY AFTER SURGERY is safe, according to a study published in the December issue of the International Journal of Pediatric Otorhinolaryngology. Researchers reviewed 797 pediatric cases occurring between January 1998 and June 2005 at the UCLA Medical Center Outpatient Surgery Center. The average post-op recovery time prior to discharge was 1.47 hours, with the complication rate for 24 hours post-op at 0.00075 percent and complications presenting more than 24 hours post-op occurring in 0.0063 percent of cases. While co-author Nina Shapiro, MD, of UCLA's Mattel Children's Hospital warns that the safe length of post-op stays should be determined on an individual basis, she says she believes discharges less than two hours after tonsillectomy can be safe, have not been shown to increase complications and may favorably impact the efficiency of an outpatient facility, allowing for more cases to be completed per day.
THIRTY-ONE NEW AMBULATORY QUALITY MEASURES in 25 surgical and medical specialties have been adopted by the AQA Alliance, which is comprised of 150 organizations working toward the measurement, standardization and improvement of physician practice. The measures, along with a patient satisfaction survey, were proposed and approved for use by the ophthalmologists, neurologists and other clinicians spanning 20 specialties and subspecialties who participate in the Surgical Quality Alliance.
AN AUTOMATIC ENDOSCOPE CLEANER has been OK'd by the FDA. The EvoTech Endoscope Cleaner and Reprocessor, manufactured by Advanced Sterilization Products, is the first and only washing-and-disinfecting system in the United States cleared to eliminate the manual cleaning of endoscopes. Indicated for use with the company's Cidex OPA Concentrate high-level disinfectant and Cidezyme GI enzymatic detergent, the system has automated cycles for cleaning, leak and blockage detection, and parameter verification. ASP says it expects the EvoTech ECR to be available for purchase by June 2007. |
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