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

Surprise! Tax Dollars Paid For Cosmetic Surgery, Spa Visits

The European Parliament

A copy of the most recent Practical Guide to the Reimbursement of Medical Expenses was recently leaked to European media and then to the public, revealing that almost £3 million of taxpayer monies will be spent in 2011 by members of the European Parliament (MEPs) for luxury items such as spa visits and cosmetic surgery!

The European Parliament has 736 members. The members, as well as their families, have already been reimbursed for cosmetic surgery, anti-aging products & treatments, massages and private spa visits, sometimes at 100% of expenses for these non-essentials.  Further, sons and husbands of MEPs have also received free Viagra, although it was claimed Viagra was given only to men whose impotence was a result of injury.  Right now, along with the rest of the globe, Europe is in a state of fiscal austerity, making these costs that much more unacceptable to the public.

Up until about 2004, American military servicemen and women received free cosmetic surgery. The reason for doing so was that military plastic surgeons were thought able to better develop their skills in reconstruction when they were allowed to also perform cosmetic procedures, ie, surgery on healthy, uninjured people. This policy was scrapped after CNN released a story about the practice. The result is that service personnel now can get cosmetic surgery at their military hospitals at a discount. Unfortunately, that means that plastic surgeons training under military hospital supervision perform fewer cosmetic cases than in the past, giving them less experience than those who went before them under the old arrangement.

To my blog readers: Do you think military personnel received free cosmetic surgery in order to train military plastic surgeons or do you think that was just a ruse so that members of the military received more percs? Share your views!

To your health & beauty,

Dr. Joe Danyo

Superficial Liposuction Anyone?

Have you heard the latest about a “new” liposuction technique? It’s called “superficial liposuction.” Proponents of superficial lipo claim that it produces smoother results and better skin tightening, but is that really true?

What is Superficial Liposuction?

Superficial liposuction removes fat from the intermediate and superficial layers, compared with conventional suction-assisted liposuction that removes fat from the deepest layers. One of the well-advertised benefits of superficial liposuction is that it provides better skin tightening and fewer surface irregularities.

Poor Lipo on Tara Reid

A Recent Report Suggests Otherwise

Several surgeons who together performed various forms of liposuction on 2398 patients over a period of 14 years recently released a report showing that the superficial lipo patients had more complications compared with traditional suction liposuction patients. One of the most frequent complications was an increased tendency for bumps and depressions in the skin’s surface, such as shown in the photo left. This confirms my opinion that superficial liposuction is not a better technique, which is why I don’t perform it. I perform tumescent lipo, power-assisted lipo and SmartLipo here in my Delaware plastic surgery practice because they consistently give the best results.

Traditional liposuction has many years of proven results by thousands of surgeons. However, no matter what liposuction procedure you undertake, it’s wise to remember that the hand that holds the cannula is your best prediction of beautiful results. I have performed thousands of liposuction procedures. Trust experience and results when you seek liposuction. Check out my photos for more proof of skill.

To your health and beauty,

Dr. Joe Danyo

Infections linked to Ear Piercing

Just when you thought it was a safe beauty option, ear-piercing has come under siege as a result of a recent study showing that ear-piercing is linked to bacterial infection. We don’t mean old-time high school piercing by your best friend with a sterilized needle and some thread, which is an obvious no-no. We’re talking about piercing performed in malls using hand-powered piercing guns.

The study, carried out at the Department of Emergency Medicine at UCLA-Harbor, involved surveying 14 businesses that pierce ears on a regular basis. Evaluated were the type of instrument and earrings used (ie, platinum vs gold vs silver posts), the level of employee training, the location of the piercing and prep and aftercare of the ears. Both tattoo parlors that performed piercings and mall-type stores and kiosks were part of the 14 businesses studied.

The tattoo parlors, in general, used sterile needles and forceps to pierce ears, while the retail stores and kiosks used piercing guns. All 14 businesses offered earrings made of 14 or 24K gold, stainless steel or other metals, and none offered earrings made with nickel (to which many people are allergic). Although the training involved videos and demos of piercing at the stores and kiosks, the tattoo parlors insisted on an apprenticeship type program of varying lengths. Both business types performed by lobe and cartilage piercings.

Here was the big difference: all the cosmetic stores and kiosks used benzalkonium chloride or isopropyl alcohol as ear preparation agents, while the tattoo parlors used iodine-based solutions. At all of the businesses, minimal aftercare instructions were given and those instructions typically focused on maintaining ear-hole patency as opposed to avoiding infection.

The study went on to show that the cosmetic shops and earring kiosks patients were more likely to have infections, particularly in the cartilage piercings. The belief is that the increased infections were a result of poor training and the use of benzalkonium chloride as a preparation agent. Some of these infections can be very severe, requiring surgery and IV antibiotics to treat a nasty bacterium called Pseudomonas.

It’s to your benefit to think about taking a bit more precautions when having someone pierce your body. Ask what kind of preparations they use on the ears or other body part prior to piercing, and make sure your tech is thoroughly trained.