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| News and Notes
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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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| Noted Surgeon Warned by the FDA
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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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| Jury: Doctors Not Liable For Cosmetic Surgery Burns
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A Los Angeles County jury rejected the medical malpractice claim of an anesthesiologist who suffered facial burns while undergoing a revision blepharoplasty when the cautery ignited a fire in the oxygen-enriched environment.
Kourash Noormand, MD, a pain management specialist, sustained first- and second-degree burns to the middle of his face and to one nostril. He had sued both the surgeon and the anesthesiologist, seeking compensation for extreme pain and suffering, surgical intervention and $120,000 in lost earnings.
Lawyers for the surgeon and anesthesiologist argued that burns of this nature are a rare but well-recognized risk of surgery. "[A fire] wasn't even on my mind," says Dr. Noormand from his Beverly Hills pain management practice in a telephone interview. "The chances are very, very minimal."
The otolaryngologist surgeon who performed the 2002 procedure testified that the fire occurred due to an oxygen-enriched environment under the control of the anesthesiologist, according to court records. Oxygen was thought to be pouring out of Dr. Noormand's nose because a nasal cannula was left in after an oral airway was placed.
The anesthesiologist denied that he was in control of the oxygen, but testified that the circulating nurse (employed by the surgery center, not one of the defendants) turned up the oxygen without his knowledge or consent, according to court records.
"The jury was convinced that it was nobody's fault," says Dr. Noormand. "The defense blamed it on the circulating nurse. Of course I was surprised. This was a kind of case where everybody was surprised."
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| Prevent Back Surgery Failures With Anesthetic Pretreatment
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Pretreating the spinal cord with a lidocaine injection before back surgery may prevent failed back surgery syndrome, the most common problem patients encounter after such procedures, according to a study in the journal Experimental Neurology. As the name denotes, FBSS occurs when pain remains after surgery, either because the patient was not cured or because the procedure itself has caused additional chronic post-op pain; recent reports indicate that patients who have spine surgery are no better off than those who do not.
Researchers at the University of Texas Medical Branch at Galveston theorized that "the unintentional stretching and compression that can occur in the spinal cord during surgery causes the release of large quantities of ... excitatory amino acids, which produce a toxic environment in the spine and cause long-term hyperexcitability in spinal neurons, generating chronic neuropathic pain — pain produced in the nerves themselves," says senior co-author Claire Hulsebosch, PhD, a professor of neuroscience and cell biology at UTMB. "When we applied lidocaine to the surface of [rats' spinal cords] before conducting our surgery, we found that those releases were completely blocked."
Further, researchers found that there was less sensitivity and neuropathic pain after the pretreatment, which could translate to faster recoveries. The researchers conclude, "Lidocaine pretreatment could offer a safe measure for prevention of chronic pain for back surgical procedures if given by intramuscular injection, or topical administration onto spinal nerves or the dorsal spinal surface during surgical procedures that include nerve entrapment release, intervertebral disc modification and laminectomies."
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