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| News and Notes
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Patients often drop noticeable amounts of weight following bariatric surgery, but the procedure may also have a less visible lifesaving benefit in reducing the risk of coronary heart disease, according to a study in the Jan. 15 issue of the American Journal of Cardiology.
Researchers at William Beaumont Hospital in Royal Oak, Mich., evaluated the pre- and post-operative body mass indexes, coronary heart disease risks and Framingham risk scores for 109 morbidly obese patients (82 women and 27 men) who underwent laparoscopic Roux-en-Y gastric bypass surgery. The investigation found that after 17 months the mean BMI dropped from 49 to 36 and instances of diabetes, hypertension and dyslipidemia resolved or improved. The patients also had lower levels of total cholesterol, LDL cholesterol and triglycerides and higher levels of HDL cholesterol. These results calculated to a reduction of 39 percent for men and 25 percent for women of coronary heart disease after ten years, and patients without the condition fared better than the age-matched general population.
The study's authors note that these data suggest a substantial and sustained weight loss following bariatric surgery may prevent death and myocardial infarction in the mordibly obese. They are planning a randomized trial to compare obese patients with coronary heart disease who undergo bariatric surgery against patients who follow a controlled diet, with the outcomes being the heart disease events over the next five years.
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| Study: Bariatric Surgery Reduces Risk of Heart Disease
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Patients often drop noticeable amounts of weight following bariatric surgery, but the procedure may also have a less visible lifesaving benefit in reducing the risk of coronary heart disease, according to a study in the Jan. 15 issue of the American Journal of Cardiology.
Researchers at William Beaumont Hospital in Royal Oak, Mich., evaluated the pre- and post-operative body mass indexes, coronary heart disease risks and Framingham risk scores for 109 morbidly obese patients (82 women and 27 men) who underwent laparoscopic Roux-en-Y gastric bypass surgery. The investigation found that after 17 months the mean BMI dropped from 49 to 36 and instances of diabetes, hypertension and dyslipidemia resolved or improved. The patients also had lower levels of total cholesterol, LDL cholesterol and triglycerides and higher levels of HDL cholesterol. These results calculated to a reduction of 39 percent for men and 25 percent for women of coronary heart disease after ten years, and patients without the condition fared better than the age-matched general population.
The study's authors note that these data suggest a substantial and sustained weight loss following bariatric surgery may prevent death and myocardial infarction in the mordibly obese. They are planning a randomized trial to compare obese patients with coronary heart disease who undergo bariatric surgery against patients who follow a controlled diet, with the outcomes being the heart disease events over the next five years.
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| Manufacturer's Scope Washer/Disinfectors On Hold
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Medical device manufacturer Custom Ultrasonics has agreed to halt the production and distribution of its endoscope washer/disinfectors until it corrects certain manufacturing difficulties, the FDA announced last week.
The company's System 83 Plus and System 83 Plus Mini-flex Washer/Disinfectors will remain on hold until production methods and controls are brought into compliance with the FDA's Current Good Manufacturing Practice requirements, says the federal agency. In addition, the company has agreed to develop and implement adequate written medical device reporting procedures.
Custom Ultrasonics has posted a letter to its customers on its Web site. "We are cooperating fully with the FDA and expect very shortly to have this matter resolved and to be in full compliance with all of the FDA's regulations," says the letter, in part.
The FDA says it isn't aware of any adverse events related to the devices, but explains that Custom Ultrasonics' manufacturing process posed a potential public health hazard since improperly cleaned and disinfected endoscopes can transmit pathogens between patients.
"Most important to our customers and to public health, we are not aware of a single report of healthcare-acquired infection or disease transmission associated with proper use of the System 83 Plus," says the company's letter. "Over the course of the past 20 years, several million flexible endoscopes have been reprocessed in the System 83 Plus without incident."
The FDA advises health care providers equipped with these products to discontinue their use and to contact the company for further information. The agency recommends using an alternative device if one is available or following appropriate protocols to manually wash and disinfect scopes. If no other options are available, providers should carefully weigh the risks and benefits of using the products.
"As the thousands of visitors to my Web site and readers of more than 100 of my published articles, position statements, editorials and guidelines know around the world, I have an unwavering and interminable appreciation and passion for the truth, scientific integrity, patient safety, and the fair and objective regulation of medical devices (and drugs) by the FDA," writes Lawrence F. Muscarella, PhD, director of research and development and chief of infection control at Custom Ultrasonics, in an e-mail.
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| Joint Commission Highlights Patient Health Literacy
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The Food and Drug Administration has warned a prominent bariatric surgeon for failing to receive informed consent from 175 patients before implanting them with an investigational device during a clinical trial. Mathias Fobi, MD, medical director of The Center for the Surgical Treatment of Obesity at St. Mary's Medical Center in Long Branch, Calif., was also notified of his failure to receive conditional approval from the FDA and the Institutional Review Board before implanting investigational devices in 185 patients. The FDA issued the warnings in a Jan. 24 letter.
Dr. Fobi is widely known for inventing the Fobi pouch weight-loss surgical procedure, a technique that divides the stomach in two and reattaches it to create a small pouch that limits the patient's food intake.
The warnings stem from an inspection of Dr. Fobi's facility between Sept. 19 and Sept. 29 of last year. According to the FDA's letter, the inspection was part of a program designed to ensure that data and information contained in requests for investigational device exemptions, pre-market approval applications and pre-market notification submissions are scientifically valid and accurate. The inspections are also aimed at ensuring that human subjects are protected from undue hazard and risk during scientific investigations, says the FDA.
According to the letter, Dr. Fobi must provide written documentation of the actions taken to correct the cited violations within 15 working days. He must also provide a list of all clinical trials in which he participated within the last five years. The FDA notified Dr. Fobi that the agency could take corrective action if he fails to respond in time, potentially disqualifying him from receiving investigational products for future clinical trials.
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