FDA to mesotherapy - Put up or shut up!

The FDA last week issued cease and desist orders for a number of clinics offering fat melting "mesotherapy" injections. 
The drugs most regularly used in this process are phosphatidylcholine and deoxycholate. Other drugs or products such as vitamins, minerals, and herbal extracts are often mixed into the "gumbo", complicating any assessment of safety or efficacy. Phosphatidylcholine is not approved for injection into your body and has never been evaluated for that use in controlled settings. The new warning shot over the bow went out to six U.S clinics:

• Monarch Medspa in King of Prussia, Pa.
• Spa 35 in Boise, Idaho
• Medical Cosmetic Enhancements in Chevy Chase, Md.
• Innovative Directions in Health in Edina, Minn.
• PURE Med Spa in Boca Raton, Fla.
• All About You Med Spa in Madison, Ind

I would strongly advise people considering using these facilities to think again, as their disregard for patient safety with off label experimentation of these injectable concoctions should signal a general disregard for their patients. As alerts to this FDA warning went out on the ambulance chaser network of websites, expect to see ads shortly recruiting clients for lawsuits.

FYI If you are interested in reading about mesotherapy, I've written several entries about it since 2007 which can be seen here.

Rob

Allergan reaches the finish line with FDA breast implant study!

Allergan, the world's largest maker of silicone gel implants, has announced they've reached full enrollment of the silicone breast implant follow up study group by the FDA when the devices were reintroduced for cosmetic use in 2006. This study involved registering patients undergoing breast augmentation going forward so as to better understand outcomes. We'll be watching data group for years going forward on reoperations, hardening, rupture rates, and other parameters.

We were proud to have our patients enroll in this important study since 2006 and have respect for Allergan's role in improving education of both surgeons and patients regarding proper selection and use of these devices.

Dr Rob Oliver Jr.
Plastic Surgery Specialists PC of Birmingham
(205) 298-8660