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

C-Tucks: Unsafe For Regaining a Post-Baby Body

While celebrities like Jessica Alba and Gisele Bundchen may be able to bounce back to their pre-baby bodies quite easily, not all women can slim down with ease just weeks after childbirth. Skinny celeb mommas—who have the luxury of hiring personal trainers, chefs, and nutritionists—have sparked rumors about a controversial new cosmetic procedure: the ‘C-Tuck’.

The C-Tuck is a cesarean section for childbirth, immediately followed by a tummy tuck (abdominoplasty).  If the idea of having a little nip and tuck during childbirth sounds too good to be true, it probably is. It is hard to find a doctor offering the procedure, however, this is not a surprise as the C-Tuck is considered to be relatively unsafe. While OB/GYNs or other unlicensed individuals may be performing C-Tuck’s under the radar, you won’t catch a board-certified plastic surgeon cashing in this trend.

The average abdominoplasty can take up to five hours, which would require an unsafe amount of anesthesia for both the mother and child. Combining an abdominoplasty with a cesarean section could be potentially deadly for both parties.  In addition, a woman’s hormone levels are spiked during childbirth and therefore the skin and soft tissue of the abdomen may not heal the same with a C-Tuck as it would with a standard tummy tuck.

C-Tucks can also run a high risk of infection as there are numerous cavities exposed to a combination of fluids during a cesarean section. By adding another in another procedure, there is more tissue exposed to pathogens. Combining a hysterectomy with a tummy tuck is a more controlled procedure that is more commonly practiced.

If you are a mom who is considering a tummy tuck, I recommend waiting at least nine months after childbirth before undergoing the procedure. Patients will see optimum results if they allow their body to heal and the abdominal skin to shrink as much as possible.  Also, you should not undergo an abdominoplasty unless you do not plan on having any more children. Giving birth after a tummy tuck can reverse the results of the procedure completely.

While C-Tucks would certainly make life easier on moms, they are neither realistic nor safe. Tummy tucks in Delaware should only be performed by a board-certified plastic surgeon, not an OB/GYN or otherwise.

LED Light And Green Tea Cream Smooth Facial Wrinkles

According to Science Daily, researchers in Germany report a major improvement in a potential treatment for wrinkles that could ultimately be an adjunct to Botox, dermal fillers and cosmetic surgery. The non-invasive wrinkle treatment combines high-intensity light from light-emitting diodes (LEDs) and a lotion made of green tea extract. According to researchers Andrei Sommer and Dan Zhu, the combination of green tea extract and LEDs is ten times faster at removing wrinkles than a similar anti-wrinkle treatment using LEDs.

Physicians have used light therapy, also known as photo therapy, for almost 50 years to heal wounds and combat skin aging. However, LED lights, much like those used in computers, have also been shown to reduce skin wrinkles when applied daily. Unfortunately, a byproduct of such extensive exposure to LEDs is the risk of cell damage. As a response, epigallocatechin, a potent antioxidant in green tea, is applied in a cream to counteract the potential for cell damage.

Researchers daily applied a LED light and green tea extract to the facial wrinkles of a human volunteer over a period of one month. The treatment resulted in smoother skin, including "less pronounced wrinkle levels, shorter wrinkle valleys, and juvenile complexion," according to the scientists. Not only could this study form the basis of a new facial rejuvenation protocol, it could lead to better understanding of cellular aging.