Archive for October, 2009

Special Surgical Glue Could Enhance Tummy Tuck

Friday, October 23rd, 2009

tummy tuck KentuckyA Pennsylvania medical company is set to begin clinical trials for a new adhesive they say could improve the safety and efficacy of cosmetic surgeries like the tummy tuck.

Cohera Medical calls the new product TissuGlu®, and recently announced plans to move forward with clinical trials this November.  As explained in a recent press release, the adhesive bonds flaps of tissue together during tummy tuck surgery to reduce fluid accumulation and thereby, the chance of complications.

Most tummy tuck surgeries require placement of a special drain to remove fluid.  A method that uses surgical adhesive could, in theory, make drains unnecessary.

Cohera Medical CEO Patrick Daly explains, “This unique product will ultimately help surgeons address a critical need and improve patient care.”  In Germany, as many as 40 patients are expected to be enrolled in clinical trials to investigate TissuGlu’s  safety and efficacy.

About Abdominoplasty

The tummy tuck is a common cosmetic procedure designed to reduce the appearance of a protruding abdomen, whether it is due to weight fluctuations, pregnancy, or aging.  See our homepage to learn more about how Dr. Edds performs this procedure right here in Owensboro, Kentucky.

Allergan Disputes FDA Marketing Restrictions

Monday, October 5th, 2009

allerganPharmaceutical company Allergan Inc.,  has filed suit against the FDA, arguing that restrictions placed on the marketing of Botox for off-label use actually work against the best interest of patients and physicians.

While Botox is commonly used – and FDA approved – to treat wrinkles on the face and forehead, a wide range of other treatment applications have been successfully used.  Doctors have used Botox to treat hyperhidrosis, migraine headaches, and muscle spasms.

Last year, the FDA announced that Botox complications had been linked to off-label use, particularly in children treated for limb spasticity.  According to current U.S. law, doctors are permitted to administer medicine for whatever application they deem appropriate.  Doctors aren’t however, allowed to market medicine for any application they please.

The marketing restrictions on Botox have apparently hindered the pharmaceutical company’s ability to distribute safety information related to off-label use.  The lawsuit is intended to increase the physician’s ability to access safety information such as possible risks, benefits, dosing, patient selection, etc. and is in no way intended to increase sales of Botox.