Here is a Plastic Surgeon with 45 years experience who spoke during the Public Comment Period of the FDA 2013 Panel Meeting about his success with PEMF Technology.
"I'm Dr. Berish Strauch. I'm Professor and Chair Emeritus of the
Department of Plastic and Reconstructive Surgery at the Albert Einstein College of Medicine in the Bronx and have practiced this discipline for over 45 years. I have significant experience, and I've pioneered techniques in microsurgery, complex reconstruction, hand surgery, peripheral nerve
surgery, as well as aesthetic surgery. I have founded and been president of a number of surgical societies and have authored many scientific articles and have published eight surgical textbooks.Additionally, I ran a funded research laboratory. It was through this laboratory that I was first introduced to the technology of Ivivi ILX devices over 15 years ago. I was able to observe its effectiveness in animals, safety, and its transformation into a clinically useful, noninvasive, low energy and disposable design.
In the last 12 years of my practice, I concentrated on body
sculpting programs as the gastric bypass procedure became safer and more frequent. We were besieged by formerly morbidly obese patients to help them be rid of their excess hanging fat and skin. A circumferential abdominoplasty with plication, tightening the muscles, was an important cornerstone of the program. It unfortunately created a postoperative period
requiring significant narcotic usage or invasive analgesia. It required several days in the hospital postoperatively to manage the pain and symptoms. The institution wasn't very happy with the length of stay numbers for my first 75 circumferentials.
The Ivivi SofPulse had been approved for human use, and I
started then to use it for these patients to control their postoperative pain and swelling. From the time I started, the next 150 patients all went home the first day postoperatively. And if they'd had pain, they would've called me immediately.
They were comfortable on moderate amounts of additional
analgesia, but no narcotics. I've used it successfully since then on the face, arms, breasts, and legs as well as the abdomen soft tissue response to this type of treatment, and pain is reduced. Even more importantly, my patients have experienced no, and I repeat, no complications or adverse effects.
As labeled, I do not use it over a pacemaker or in children. I
even used it on my wife of 57 years, two weeks ago, when she had surgery on the nose.You've got to be pretty comfortable with the technique if you're going to use it on your wife. She was very impressed with the lack of pain.
Even more importantly, so was her surgeon; not me.
I used PMF in a demonstration study for control of postoperative pain and swelling on postop liver transplants, postop kidney transplants, and a great variety of surgical procedures, all with good success using the same scale that the statistician was talking about. We've not published this, but we've used it, and it's effective.
Canceling the current 510(k) designation and leaving the
technology in category III would effectively remove this modality from the market. Today, when everyone, including the FDA, wants to decrease the use of narcotics in postoperati
ve patients, why would we want to eliminate a
technology that is safe and effective and noninvasive? This device controls postoperative pain in soft tissues without the use of strong narcotics. This is safe technology. I believe we should move this to category II, and I urge you to do this."
