Medical blog » Implants

FDA Allows Brain Implants for Obsessions

admin — Mon, 23 Feb 2009 03:29:08 +0000

Once the electrodes are implanted, clinicians can control how electrical pulses are delivered to the brain using a battery-run, pacemaker-like device outside the body. By trial and error, doctors figure out what patterns of electrical activity are most likely to help patients while producing the fewest side effects.
OCD is a condition that prompts people to have debilitating and recurring thoughts and compulsive behaviors, such as hand-washing. It is an anxiety disorder, and the FDA approval suggests officials believe that deep brain stimulation might help reduce anxiety. The device was approved for use when conventional treatments, such as medications and talk therapy, have not worked.
The FDA action was designated a “humanitarian device exemption,” a regulatory mechanism designed to encourage the development of treatments for disorders that affect fewer than 4,000 people in the United States. Manufacturers do not have to prove that the device helps patients, only that it can be used safely and is likely to be effective. The FDA said it based its decision on a small study that found deep brain stimulation improved the condition of 26 patients with persistent obsessive-compulsive disorder by an average of 40 percent.
The device approved by the FDA is called Reclaim and is manufactured by Medtronic Inc. of Minneapolis.

2 Years after FDA Approves Silicone Breast Implants, Santa Barbara …

admin — Wed, 07 Nov 2007 17:18:38 +0000

2 Years after FDA Approves Silicone Breast Implants, Santa Barbara Cosmetic Plastic Surgeon David L. Buchanan, MD Discusses the Decision’s Impact
After a series of highly publicized lawsuits regarding the safety of silicone breast implants, the U.S. Food and Drug Administration pulled the implants from the market for further study. Following years of rigorous testing and clinical trials, the FDA approved them for use in breast reconstruction and breast augmentation procedures in 2006. On this two-year anniversary of formal approval, one cosmetic plastic surgeon in Santa Barbara offers his views.
) February 18, 2009 — Dr. David L. Buchanan, a
, has specialized in reconstructive and aesthetic breast surgery for more than 27 years. He says that in the past two years, approximately 95 percent of his patients have chosen silicone gel implants over saline implants.
“They feel much more like regular breast tissue, and do not deflate – with trauma or spontaneously – which occurred in 4% to 16% of patients over a seven year study of saline implants.”
Dr. Buchanan has spent decades performing breast surgery. While in plastic surgery residency at Baylor University in Houston, Dr. Buchanan worked extensively with Dr. Frank Gerow, the inventor of the silicone gel implant. Dr. Buchanan believes the FDA’s decision to approve silicone breast implants after a decade of voluminous and careful study was the right one. “There is currently no scientific evidence that silicone gel breast implants are harmful. Silicone is widely used in medicine every day. Needles are routinely coated with silicone, and silicone is used in intravenous tubing lines.”
In addition to aesthetic breast enhancement procedures such as breast augmentation and breast lift, Dr. Buchanan is known for being the first plastic surgeon in the southern coastal California region to perform TRAM and Latissimus muscle flap breast reconstruction for breast cancer patients in the early 1980’s. Dr. Buchanan says silicone gel breast implants were often used in these procedures in conjunction with the patient’s own tissue to create soft, supple natural-appearing breasts. He says gel implants were extensively used for elective breast augmentation as well.
In 1991, silicone breast implants were taken off the market for further study. In 2006, they returned to the marketplace, having been FDA-approved for use in breast reconstruction surgery for patients of any age, and aesthetic breast surgery procedures for patients 22 and older.
Dr. Buchanan says he tells patients considering breast reconstruction or
that if it were his wife or daughter who needed to make the choice between silicone and saline, he would always recommend silicone gel breast implants. “They provide a superior result with less need for reoperation. Contrary to some internet reports, these devices are designed to last a lifetime, and should not need to be replaced unless there is a complication or injury.”
Dr. Buchanan says he is delighted that his
and breast reconstruction patients now have more options, and that the scientific method has prevailed.
, Dr. David L. Buchanan can be reached at 427 Pueblo Street, Suite A, Santa Barbara, California 93105 – (805) 395-4545, or via his website at
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Implants help runners regain fitness

admin — Thu, 09 Aug 2007 22:04:34 +0000

The winner of three New York City Marathons and one Boston Marathon in the 1980s, Salazar coaches elite runners, including Duluth native Kara Goucher. Some of them were with him last year when he collapsed and stopped breathing.
Salazar, 50, went 14 minutes without a pulse before paramedics restarted his heart with an external defibrillator. He had a cardioverter-defibrillator implanted while recovering in the hospital, and the security the device gives him has helped him work his way back to the condition he was in before the heart attack.
“There are a lot of people out there with pacemakers and defibrillators who are very active,” he said. “I run four or five miles a day, five or six days a week, which is a good, healthy thing to do. If I didn’t have the defibrillator, I would be scared to death. It allows me to be healthy.”
Jungbauer ran three Grandma’s Marathons and as many as 50 miles a week in the early 1980s. A lower-back injury suffered in a 1988 fall made it too painful to run, and a 1999 auto accident and 2002 construction injury damaged his neck and made things worse.
He was able to bike and water ski, but he missed the serenity of distance running. He had the last of his plates and bone grafts implanted in 2003 as he edged his way toward the 200-pound mark. Eager to get back into better condition, Jungbauer learned to stretch properly to ready his body for exercise, and he resumed running in 2005.
He made it 2 1/2 miles on his first day. Last year, he ran across his Senate district from East Bethel to Elk River, covering 21.7 miles.
“If that 2 1/2 miles was all I could do, I would have been happy, because I was back on the road,” said Jungbauer, an advocate for health and wellness issues. “A month after I got into Global Heroes, I threw my back out, and I didn’t know if I’d be able to run. But I thought, ‘It took me 18 years to get back the first time. Let’s see if I can do it in four months.’ And here I am.”
Oesterle hopes the Global Heroes will inspire people, even those with health problems, to become active. It worked for him. An avid runner and marathoner, he will be running the TC 10 Mile after having a hip replacement.