ASAL take greater measures in 2008 to monitor Lipodissolve in clinical use

New York, NY (JULY, 2006) -- Lipodissolve popularity continues to grow in the United States. The simple, quick and mild treatment is popularized by patients both in Europe and this country. In raising concerns over pseudo-Lipodissolve procedures spreading across the country with unknown protocols ASAL is taking new measures in 2008 to monitor Lipodissolve in clinical use by its certified members.

Companies like Fig in St Louis with branches in several states got in the hot seat recently from advertising modified pseudo-procedures as 'Lipodissolve' across the country. These efforts eventually lead to numerous cases of adverse reactions. Concerned of these reports, ASAL is taken precautionary measures and are closing their doors on non-certified physicians having access to the compounds being used in Lipodissolve for better safety measures.

A spokesperson for ASAL say, "The explosive interest in Lipodissolve by the public in a rather short time, has caused numerous imitation procedures to spring up across the country. Everyone wants to reinvent Lipodissolve."

But, pseudo procedures can be misleading.

"Some medical professionals don't even go for training, but simply read a few reports on mesotherapy, deoxycholate or lipodissolve from medical journals and feel they know enough to open clinics across the country rather than rely on reports from years of careful development of safe protocols. Lipodissolve is a great and simple procedure, but it is still a medical procedure. Lipodissolve accomplish the best cosmetic results, of all popularized injection lipolysis procedures available. Especially when it is followed with aftercare and oral supplements."

New products available only to Lipodissolve certified physicians

"It would be ideal if the State Medical Boards would keep a track of what is happening in clinics across the country and work together with us to monitor protocols better. But since they don't - we will do our part and take the initiative to monitor treatments and safety reports from our physician members even more."

The new policies in 2008 in collaboration with a pharmaceutical supplier, will restrict purchases of medications only to Lipodissolve certified physicians. New policies will also demand that clinics have to submit a certain number of case studies per year to ASAL. These reports will be collected annually to be made available for review by State Medical Boards and other regulatory bodies on request.

Past efforts to monitor medicines have failed

ASAL has been eyeing the same policies in the past without sufficient success, and say, "many compounding pharmacies don't want to restrict their sales, and therefore refuse to collaborate within the policies ASAL want in effect. They further avoid to reveal how the product is manufactured, which is important information for us to evaluate the quality of the product in relation to this procedure. Our demand is that the pharmaceutical use for new procedures like Lipodissolve are monitored by the manufacturer with clinical feedback. In 2008 we hope we have accomplished a change in this."

"Anyone who believe Lipodissolve involve only phosphatidylcholine (PPC) injections from any available compounding pharmacy is mistaken. There is a difference between pseudo procedures and actual Lipodissolve. In addition, the popularized use of excess deoxycholate is not encouraged in the ASAL Lipodissolve protocols. Deoxycholate use has become one of the main concerns we have in pseudo procedures touting themselves to be Lipodissolve. The product is simply too aggressive and cause excess pain and other risks."

Non-physicians require supervision by a licensed physician

Other restrictions have been observed by demand from ASAL since the beginning of 2005. Medical treatments provided by non-physicians on their own is a violation against regulations set by State Medical Board in several states across the country. ASNA does not provide certification to non-physicians without a supervising physician being certified as well. Non-physicians are not provided membership or added onto the members database for patient referrals to try and avoid potential misuse of state regulations.

"Nurses, for example, often accomplish wonderful cosmetic results with Lipodissolve. However, a nurse cannot replace a physician and are not license to practice medicine. Although a nurse is an invaluable asset to a medical clinic, the reality is that they are not legally authorized to provide patient consultation or patient evaluations. Therefore, the growing number of medical spa's that are now offering mesotherapy, and what they claim to be Lipodissolve, without the presence of a supervising physician is a cause of concern to us."

The new policy, to be put in effect by the compounding pharmacy providing the medical supplies, is intended to protect Lipodissolve from pseuo-procedures: "We hope that by implementing these policies for 2008, regulatory bodies will feel confident in continued ASAL Lipodissolve safety, and be more aware that there are different procedures out there touted under the same name. Our physican member feedback has shown only 0.017% reports of adverse reactions in more than 11,650 treatments performed in 2007 with ASAL protocols. This report has been issued for publication. Most reports with reactions had changes in protocols or other medications added to the protocols."

ASAL Lipodissolve® has been applied for trademark protection both in the United States and abroad to distinguish ASAL protocols from imitation procedures. The application was recently granted approved for protection in 27 countries.