Tag Archives: fda approval

From Spoiled Sausage to Faces in 200 Years: Happy Birthday, Botox!

Botox turned 10 years old on April 15th. or rather, the FDA approval for cosmetic use had its 10 year anniversary. however you want to look at it, this injectable, reverser-of-time has transformed the medi-beauty industry. the number of Botox procedures has jumped 67% since 2002, according to statistics from the American Society for Aesthetic Plastic Surgery. And 6.4 out of 10 reviewers say it's worth a shot. 

in honor of this occasion, the folks over at In Your Face, a column for the Orange County Register, created an in-depth timeline of the origins of Botox. from being discovered in spoiled sausages to inhabiting the faces of huge Hollywood stars, it has come a long way.

1820s: German doctor Justinus Kerner identifies a toxin in spoiled sausages that causes food poisoning. the paralytic illness caused by Kerner's "sausage poison" earns the name "botulism," from a Latin word ("botulus") for sausage. Kerner speculates that small doses of the toxin might be used to treat nerve disorders and excessive sweating.

1895: Belgian bacteriologist Emile Pierre van Ermengem discovers that Clostridium botulinum bacteria produce the botulism toxin.

1920s: Botulinum Toxin Type A is first isolated from the Clostridium botulinum bacteria in a purified form as a stable acid precipitate by Dr. Herman Sommer at the University of California, San Francisco.

1940s: During World War II, American scientists explore potential use of botulinum toxin as a weapon. the U.S. produces botulinum toxin capsules for Chinese prostitutes to drop into the food of high-ranking Japanese officials. the plan is not put into effect because the military found it to be ineffective as a weapon.

1946: Researcher Edward J. Schantz, Ph.D. succeeds in purifying Botulinum Toxin Type A into crystalline form, for the first time providing scientists with the raw material necessary to study the molecule in greater detail.

1949: Researcher Dr. Arnold Burgen and colleagues in London discover that botulinum toxin blocks communication between nerves and muscles.

1960s: Ophthalmologist Alan Scott in San Francisco injects botulinum toxin into monkeys to see whether it relaxes muscles that cause crossed eyes.

1978: Scott wins approval from the Food and Drug Administration for extensive multi-site tests of botulinum toxin as a treatment for crossed eyes in humans. he calls the drug Oculinum and establishes Oculinum inc. to make and sell it.

To see the rest of the timeline, head over to OC Register. They also have a pretty cool slideshow

Photo credit: Kyle Sackowski, the Orange County Register

From Spoiled Sausage to Faces in 200 Years: Happy Birthday, Botox!

Liposuction Device Lawsuit Going Forward

A federal judge has rejected a Pittsburgh plastic surgeon’s request to dismiss a lawsuit involving a liposuction patient, a medical device in development and a clinical trial allegedly conducted without the patient’s consent.

Dennis Hurwitz, MD, FACS, performed liposuction on the hips, thighs, arms and stomach of patient Rae Schiff in March 2010. According to court records, their pre-surgical consultations had not significantly addressed the possibility of using an investigational radiofrequency skin-tightening technology.

But Dr. Hurwitz used the device, called BodyTite by Israeli manufacturer Invasix, during the procedure, as part of a clinical trial for which the company was paying him. While it’s presently marketed in Canada, Europe and Asia, BodyTite is still awaiting FDA approval in the United States.

In the months following her surgery, Ms. Schiff claimed to be in excruciating pain that was uncontrollable by medication as a result of the device’s thermal injury to her cells, tissue, nerves and lymphatic system. in addition, she complained of irregular scars and scar tissue at the surgical site.

She sued Dr. Hurwitz for negligence, failure to obtain informed consent and battery, seeking a jury trial and financial damages. Not only was she unaware of and uncompensated for her participation in a clinical trial, the lawsuit alleges, she was not informed of the device’s risks; the contraindications that might have disqualified her from the trial; the fact that the FDA hadn’t approved the device and wasn’t involved in the trial; and the payment Dr. Hurwitz was receiving from Invasix.

The lawsuit also cites the Hurwitz Center for Plastic Surgery, Invasix and the Essex Institutional Review Board (a for-profit company which oversaw the clinical trials) for negligence, infliction of emotional distress and unfair trade practices, among other charges.

Dr. Hurwitz, a representative of Invasix and Ms. Schiff’s attorney did not immediately return calls seeking comment.

David Bernard

Liposuction Device Lawsuit Going Forward

Top 10 Plastic Surgery Predictions for 2009

The American Society for Aesthetic Plastic Surgery (ASAPS), the leading national organization of board-certified plastic surgeons who specialize in cosmetic surgery, offers its predictions for cosmetic surgery in 2009. Predictions are based on interviews with leading plastic surgeons around the country.

1. Aesthetic Medicine has seen a dramatic increase in the diversity of the patients treated over the past decade and this trend is expected to continue to grow stronger than ever, with applications that cater to all people. the appeal of both aesthetic surgery and cosmetic medicine will continue to spread across the spectrum of our population, as plastic surgeons further tailor treatments to meet the sometimes unique needs of that expanding population.

2. the growth and popularity of cosmetic fillers (Evolence, Juvederm, Restylane, etc.) will continue to increase as products continue to evolve and new players enter the market.

3. as our population increasingly realizes the dangers and health consequences of obesity, the number of patients seeking plastic surgery procedures (www.surgery.org) for body contouring after dramatic weight loss (abdominoplasty, lower body lift, upper arm lift, etc.) will rise in 2009.

4. Reloxin (an injectable form of Botulinum Toxin Type A) will gain FDA approval and compete with Botox (the most popular cosmetic procedure for the past 5 years) and other similar products may begin to enter pre-market clinical trials.

5. Consumers looking for a bargain on cosmetic procedures will unfortunately lead to an increase in horror stories about “discount injectables” bought offshore and cosmetic medicine and cosmetic surgical procedures performed by untrained or poorly trained practitioners.

6. Experimental techniques for non-invasive fat removal (SonoScultpt, UltraShape) as a future alternative or adjunct to liposuction (lipoplasty) surgery, will continue be tested in clinical trials.

7. Men will represent a growing segment of the aesthetic surgery market. (According to a February 2008 consumer survey commissioned by ASAPS, 57 percent of men approve of cosmetic surgery, and 20 percent would consider having cosmetic surgery. Seventy-nine percent (79%) of American men surveyed said they would not be embarrassed if people in addition to their family and close friends knew they had undergone cosmetic surgery.)

8. as the popularity of non surgical and minimally invasive procedures continues to grow; surgeons and manufacturers will develop new techniques and products that advance the science, produce even better results and lessen recovery time.

9. Cosmetic surgery “vacations” will become less popular as educated consumers understand the safety and risk issues associated with surgical procedures and travel. Surgery performed by board-certified aesthetic plastic surgeons, in accredited facilities where follow-up care is available will continue to be the safest option and the best value.

10. following the trend in increased consumer sophistication regarding healthcare choices, board certification of practitioners, and accreditation of surgical facilities will play an even more important role in choosing a cosmetic surgeon. <<

For more information, visit www.surgery.org

Top 10 Plastic Surgery Predictions for 2009

Smartlipo laser liposuction technique vaporizes the fat

A laser procedure called Smartlipo laser liposuction technique melts down the fat and tightens the skin is awaiting FDA approval. The laser liposuction procedure is the first of its kind to burn and vaporize fat. The technique is currently implemented in Juva Skin and Laser Center in Midtown, for the past 6 months, as part of FDA-authorized study for the company. The procedure is performed under local anesthesia and does not involve any stitches or formation of scars after the surgery. The cost of Smartlipo procedure is $3,000 to $4,000 for an area. The procedures corrects double chins, upper-arm batwings and unsightly cellulite in an hour or less.

Update Nov 9th, 2006: Smartlipo procedure is FDA Approved. at this time we don’t believe that there are any further FDA trials going on.

To Locate a doctor visit: Practitioner Locater

Smartlipo laser liposuction technique vaporizes the fat