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FDA ISSUES A WARNING…”LIPODISSOLVE.”

Monday, August 23rd, 2010

FDA ISSUES A WARNING TO MEDICAL SPAS, RAISING THE ISSUES OF SAFETY AND EFFECTIVENESS OF “LIPODISSOLVE.”

Medical Spas around the country were recently issued a warning from the FDA for making misleading and/or false statements about the safety and effectiveness of LIPODISSOVE.  At Cosmetic Plastic Surgery Clinic in Savoy (Champaign-Urbana) and Bloomington, we encourage consumers to think twice about signing up for an elective procedure like Lipodissolve that could be putting them at risk.   While many people believe that lipodissolve is a brand new procedure brought about by “leading edge medical spas,” in reality it is simply the use of multiple injection s of a combination of drugs that is said to create possible partial destruction of fat cells.  Consumers need to be aware that these substances have not been evaluated by peer review and have not been approved by the FDA. The safety of the drugs being used in Lipodissolve is unknown.

The use of these drugs began many years ago in the 1970’s in Europe and South America when drugs were used to try to modify the structure of fat in a technique called mesotherapy.  Mesotherapy was not able to provide safe, consistently effective results. More recently, Mesotherapy was “re-invented” in the United States through the term of Lipodissolve.  Spas inject deoxycholate or phosphatidylcholine into the fat to destroy and/or modify the structure of fat.  The effects of the medication cannot be properly controlled, since the diffusion rate; that is, the rate in which the substance moves through the tissue cannot be predicted. Therefore, the reach of these substances vary from individual to individual and from injection to injection.  If one looks at the results of mesotherapy throughout the years in Europe and South America, they have been haphazard.  The procedure has never been able to gain a foothold as a venue for treatment of fat deposits anywhere in the world.  The resurrection of this technique in the United States is at the present time, an unproven technique without validation by peer review and is outside the limits of approval by the FDA.  Frankly, practitioners that use these drugs, whether in a medical spa or outside a medical spa, do it at their own risk.  In my opinion, they also put the safety and well being of their patients and/or subjects at risk.  Specifically, the FDA sent letters in April to the following spas:

  • Monarch Medspa, King of Prussia, PA
  • Spa 35, Boise Idaho
  • Medical Cosmetic Enhancements, Chevy Chase, MD
  • Innovative Directions in Health, Edina, MN
  • PURE Med Spa, Boca Raton, FL
  • All About You Med Spa, Madison, IN

Stating that the drugs utilized have not proven to be safe and/or effective, also noting that these substances have not been approved and that the involved companies have made claims that lipodissolve has an outstanding safety record and is superior to other fat removal techniques including liposuction.  FDA regulators have called on the spas to stop making such misleading claims of safety and effectiveness, and to notify the agency within 15 days of what steps they are taking to correct the violation.

The FDA, as a regulatory agency, has received reports of adverse effects such as scarring, skin irregularity, painful nodules in the subcutaneous tissue where the material was injected, etc.  As consumers, we need to remember that tumescent liposuction as a procedure has proven to be safe and effective by peer review. It is practiced worldwide.  Tumescent Liposuction has an unmatched safety record and when done by experienced cosmetic or plastic surgeons, has revolutionized the treatment of bulges, fat pockets and localized unsightly fat deposits.  Buyers beware – gimmicks cannot replace proven procedures.    The FDA seems to corroborate what surgeons have known for many years.  While tumescent liposuction has been proven safe and effective, no such approval exists for lipodissolve.

Dr. Castillo, Past-President of American Society for Liposuction Surgery

G. D. Castillo, M.D.
COSMETIC PLASTIC SURGERY
Become a Facebook Fan of CPS @  http://www.facebook.com/pages/Cosmetic-Plastic-Surgery/65943304419
https://www.cosmeticplasticsurgery.com
800-252-7123 (within IL)
217-359-7508 Savoy (Champaign-Urbana)
309-662-0436 Bloomington

Gynecomastia – Large Breasts in Males

Friday, October 2nd, 2009

When males of any age develop large breasts, it can be very damaging to their self-esteem. Though large male breasts are actually quite common, often the result is social isolation. This creates a distressing and debilitating body image that most males try to camouflage with tight upper garments and very loose clothing.

Many of our male patients who suffer from excessive breast tissue, express their inability to really enjoy life. They are embarrassed to take their shirt off.  It constricts their willingness to be social and participate in sports. They are unable to enjoy vacations at the beach and most summer related activities.  Most importantly, it changes their ability to interact within key relationships in their lives.  Many males find it difficult to feel masculine during intimate moments with their partner. They find that it even inhibits the way they interact or play with their children.

Male breasts are the result of increased volume of both fat and glandular breast tissue.  At Cosmetic Plastic Surgery, our patients learn that male breast tissue is indeed an occurrence in 100% of males. However, this tissue is vestigial, that is, it is present in very small amounts in most males  For reasons associated with genetics, diet, and environmental factors, the amount of both fat and breast tissue can increase in the breast area of males of all ages (aging men, young men, children alike…).

At Cosmetic Plastic Surgery, the treatment for this problem is both effective and simple.  Very often patients ask me, “Dr. Castillo, can this problem be solved with liposuction?”  The answer is a definitive no. The treatment is two-fold.  It involves the removal of fatty tissue from the pectoral area through liposuction with very small cannulas. We do this using traditional tumescent liposuction techniques and ultrasonic-assisted liposuction.

Then we create a small, invisible incision in the nipple- areolar region. This incision is utilized as a window. With special, delicate instruments, we use this window to remove a significant portion of breast tissue which in most individuals is not accessible for removal through liposuction, because it is very thick, fibrous, glandular tissue.  It is removed by dissection with special instruments that create no injury to the surrounding tissues.  The entire procedure takes two hours, and cleanly and effectively removes all of the offending breast and fatty tissue from the area.

A fitted garment is used and worn underneath normal clothing for the first week after surgery. Very small sutures are removed within six days after the procedure.The patient is allowed to do routine light physical activities within three days after the procedure.  This procedure, known as excision of male Gynecomastia will help to resolve the lack of self-confidence that can occur after years of teasing and scrutiny. It will reveal a more masculine male contour of the chest. It has been universally successful and there is a remarkable lack of problems associated with it. The changes in self-esteem and positive personality reinforcement are seen immediately.  It has been a most satisfying way of correcting a rather disturbing problem for our patients.

If you would like further information on this subject, call our office to schedule a consultation. During consultation, we can discuss your desires and concerns. You will be able to view before and after photos of other patients who have undergone this procedure.  We will answers any questions you may have and give you the information needed to help you decide if this procedure is right for you.

Click on this link to view male breast reduction photos : https://www.cosmeticplasticsurgery.com/photo-gallery/details.cfm?ID=29&StartRow=1

Click this link to learn more about Dr. Castillo and liposuction :  https://www.cosmeticplasticsurgery.com/cosmetic-surgery/liposuction.cfm

Dr. G.D. Castillo, Triple-Board Certified Cosmetic Surgeon

G. D. Castillo, M.D., FASC
Director of COSMETIC PLASTIC SURGERY
Become a Facebook Fan of CPS @  http://www.facebook.com/pages/Cosmetic-Plastic-Surgery/65943304419
https://www.cosmeticplasticsurgery.com
800-252-7123 (within IL)
217-359-7508 Savoy (Champaign-Urbana)
309-662-0436 Bloomington