Thursday, July 29, 2010

Advances in Reconstructive Technology Said to Improve Function, Aesthetics

Patients who have suffered facial trauma or bone loss are often faced with difficulties chewing, speaking, swallowing, or even breathing. While the aesthetics of facial reconstruction are important, the ability to restore adequate function to the face is imperative. Researchers at the University of Illinois and the Ohio State University Medical center have applied a new technique to create custom-made implants for both form and function.

Based on its design and composition, the face is by far the most complicated part of the human skeleton. According to Glaucio Paulino, the Donald Biggar Willett Professor of Engineering at University of Illinois, mid-face reconstruction is difficult due to the unique shape and functions of the bones, as well as its high exposure to bacteria through the mouth and sinuses.

Reconstructive surgeons traditionally graft bones from other parts of a patient’s body to sculpt the skull portion. Considering bone density and shape differs greatly throughout other parts of the body, patients also suffer cosmetically as well and functionally following facial reconstruction. The two universities applied an extensive type of 3-D modeling, called topology optimization, to design the custom implants. Topology optimization is primarily used to engineer skyscrapers and automobile parts, however, may become advantageous to the medical industry.

The technology helps engineers to create pieces that meet high aesthetic standards while performing at optimal levels. Topology optimization is ideal when paired with facial reconstruction, allowing engineers to develop patient-specific bone replacements with precision. The engineering process calculates different variables including blood flow, chewing forces, soft tissue support and sinus cavities.

The researchers aspire to adopt topology optimization in the future for the purpose of tissue engineering. If successful, tissue and bone can be recreated for different parts of the body that require reconstruction. Such progression in medical technology could prospectively supersede the necessity for bone grafting from a patient or cadaver.

Tuesday, July 27, 2010

Don't Get Mad, Get Botox®

Getting rid of wrinkles is a reason for anyone to smile. A recent study found that Botox® could also improve someone’s mood simply by limiting his or her ability to frown.

The study, which was performed by researchers at the University of Wisconsin on 40 volunteers, tested how the patients reacted to emotional statements following an injection of Botox®. The subjects were asked to read messages that ranged from “angry” to “sad” to “happy”. Researchers then gauged the patient’s mood by observing how long it took to respond to each statement.

The subjects of the trial took slightly longer to respond to the negative statements following their treatment than they had before their Botox® injections. The elongated response time indicated that the brain had a harder time processing the negative emotion following the treatment.

"There is a long-standing idea in psychology called the facial feedback hypothesis Essentially, it says, when you're smiling, the whole world smiles with you. It's an old song, but it's right," says the study’s author, David Havas.

The facial feedback hypothesis, which dates back to Charles Darwin in the late 1800s, is the idea that one’s facial expressions can have an effect on emotional experience.

According to the research leader professor Arthur Glengerg, the brain would normally send signals to the facial muscles to frown, and in return the extent of the frown would be sent back to the brain. Under the influence of Botox®, the muscles in the face are weakened and the intensity of the emotion is in turn disrupted.

Botox® can also have the same effect on happiness as well. When injected into the lower part of the face, Botox® can obstruct a normal smile and in turn effect the brain’s ability to comprehend pleasure levels.

Thursday, July 15, 2010

LipoSonix Not FDA Ready reported recently that the FDA issued a letter to Medicis, the maker of Dysport®, notifying the company that data presented in the 510(k) application to market the LipoSonix system was insufficient. According to the FDA, Medicis must file a new submission with additional information before LipoSonix can be marketed in the U.S.

The FDA's letter to Medicis offered guidance as to the additional information needed to obtain 510(k) clearance. Medicis plans to pursue a meeting with the FDA to present the additional data and to formulate the next steps. The letter from the FDA did not request nor highlight any missing safety data and acknowledged that the agreed primary endpoint of the clinical trial was achieved.

LipoSonix technology uses ultrasound energy to destroy fat cells without harming the skin. The destroyed fat tissue is transported to the liver where it is processed as energy. The treated fat is permanently removed, leaving the patient with a slimmer, more contoured body.

According to Medicis, the LipoSonix system is unlike body contouring technologies because it is highly targeted and has the ability to concentrate energy at specific depths of abdominal fat. By doing so, underlying tissues and non-targeted areas are not damaged.

Results are typically seen in about 8 to 12 weeks. LipoSonix is currently available in Canada, France, Germany, England and Spain.

Novabel® Pulled From Market

Novabel®, a dermal shaper harvested from marine algae extract, has been taken off of the market by Merz Pharmaceuticals. The decision came after numerous patients reported temporary bruising, swelling and lumps, particularly around the under eye area.

Novabel® is currently marketed as a safe and virtually pain-free treatment with minimal side effects and results that last up to twelve months. However, due to these latest patient complaints, Merz has decided to cease production on Novabel® until they are able to re-release the product without any kinks. Biocompatibles’ CellMed branch, the developers of Novabel®, are currently working with Merz to address the problem.

"I am confident that our CellMed team will have a safe and effective technique for sensitive areas ready for evaluation in the next few weeks," said Biocompatibles’ chief executive Crispin Simon.

Novabel® differs from traditional dermal fillers like Restylane® and Juvederm® as it is not made of hyaluronic acid. Traditional fillers are likely to have more pronounced side effects in sensitive areas than Novabel®. Until the latest issues are resolved, Merz will suspend the product until they can accurately market Novabel® for it’s minimal side effects.

Novabel® was released in the U.K. in February of this year and is not yet FDA approved. With promising results expected from Novabel®, we hope that Merz will have it back on the market soon.