FDA Intends to Speed Up Approval of Medical Devices

The FDA conducts studies and grants approvals for innovative medical devices in much the same fashion as it does for new drugs. Although the approval process for a new drug can take up to 12 years in research and development and cost well over a billion dollars before the FDA gives its approval, the approval process for devices used for cosmetic enhancements like liposuction technology, lasers and the like, tends to be even longer, requiring at least 10 months just for the first round of investigation by the FDA, that of confirming that the device is a “first-of-a-kind,” and not just a slightly-altered version of another device.  

An article in Bloomberg Businessweek reported on a new system at the FDA, called the Innovation Pathway, that intends to shorten the time for first-of-a-kind devices from 10 months to 5 months. The first product assigned to this new system is a brain-controlled, prosthetic arm created by the military.

Alhough th US is considered a powerhouse in the development of new drugs and other technologies, our country is the 7^th slowest nation when it comes to approving medical devices, lagging way behind Israel, India and European countries like France and Germany. Unlike the US, most European countries’ regulatory processes are much more supportive of innovation, while still ensuring consumers that what they approve meets the tests of safety and effectiveness. The Innovation Pathway program is the first attempt in 35 years to shorten the approval time for devices.

Technology will continue to move as quickly as the FDA will allow it, bringing us newer and better devices for liposuction, breast reconstruction and breast enhancements, and all kinds of laser skin treatments. I’m delighted that the FDA has taken this step and look forward to faster approvals for medical devices of all kinds, both for reconstruction and for cosmeteic purposes. It’s a needed step in the right direction.

To your health & beauty,
Dr. Joe Danyo

Supplements for Thinning Hair

Hair loss sufferers are in the millions here in the US. About 35% of men and 21% of women suffer with hair loss including thinning and balding. The topic was discussed recently on The Doctors in which they aired a show featuring Jon Lovitz, the comic. The Doctors physicians offered these lifestyle changes to boost hair retention and quality:

• Eat More Protein because like your bones your hair is primarily composed of protein. The suggestion is to eat more beef, chicken and eggs to help boost protein levels. For vegetarians and vegans, vegetables such as broccoli and spinach, as well as beans, nuts, seeds, and grains like quinoa, are good sources of protein.

• Get enough Iron and Zinc, because these two minerals are needed for hair follicles to produce new hair. Red meat and green leafy vegetables are high in iron and zinc, as are avocadoes and most berries. To increase your absorption of iron, it’s suggested to eat foods rich in vitamin C when eating iron-rich foods, and to avoid taking iron supplements and vitamin E at the same time. Fact: The tannins in regular teas (ie, non-herbal) can dampen iron absorption.

• A mineral known as Silica assists the body to digest nutrients needed for great hair. Silica is founding abundance in cabbage, bell peppers, rice, bean sprouts, and onions, and often thought to be the reason that Asian women have such thick, beauatiful hair, as those foods are big ingredients in Asian cuisine. Asparagus, oatmeal, cucumbers, lettuce, potatoes, sunflower seeds and strawberries also contain ample amounts of silica.

• One more rep: Because exercise stimulates circulation and blood flow, it may stimulate more hair growth.

Dr. Ordon from The Doctors also recommends Propecia and Rogaine to fight against hair loss. For those with balding, there are technologies for hair replacement available today that are superior to the old-fashioned, visible hair plugs, and certainly are a better solution than toupees, wigs or hair extensions.  

To your health & beauty,

Dr. Joe Danyo

Is International Surgery Worth the Risk?

Because we’re living in a cost-conscious time, we want the best value for our dollar, whether it’s a purchase of Tide or cosmetic surgery. However, there’s a huge difference between the two. A box of Tide is the same box no matter where you purchase it, but a breast augmentation, tummy tuck or facelift is an individually-performed surgery that can have adverse consequences if performed by someone without adequate training and experience.

In the past month, the Attorney General’s office in New York state charged a Manhattan-based Dominican Republic physician with unauthorized practice of a profession. Apparently this surgeon has been advertising cheap plastic surgery, then examining the patients in Manhattan before they flew to the Dominican Republic for the actual procedure. Evidently, there were complaints that his patients developed severe infections and disfigurement.

It’s very important that you examine the background of any surgeon you interview about cosmetic surgery. While it can be cheaper to have a procedure in another country, the cost of airfare, hotel, meals and the need to bring a companion can offset any potential savings. Further is the potential for negative consequences such as infection, disfigurement and even death. In the US, surgeons are held to a very high standard in their operating facilities. Unfortunately, with so many onsite operating rooms, this still leaves room for cut-rate physicians bent on doing thousands of surgeries at cheap prices to cover their overhead. Many of these practitioners don’t even carry malpractice insurance. I am a Delaware board certified plastic surgeon--that means I've been certified by the American Board of Plastic Surgery as skilled and experienced through exams and photo evidence of my work. 

You can’t put a price tag on training and experience. You wouldn’t let an unqualified plumber in the door, so be sure to check out your surgeon! 

To your health & beauty,

Dr. Joe Danyo