Botox bash: FDA approval

FDA approval of the wrinkle remover leads to new type of party in Naples

By BETH FRANCIS, [email protected]

There’s been a Botox party sighting in Naples.

Propelled by the Food and Drug Administration approval of Botox to remove frown wrinkles, experts say they expect the nations’ most popular non-surgical cosmetic procedure to become even more sought after with demand doubling or even tripling.

The parties started in Los Angeles and New York as a basic twist on the familiar Tupperware party.

Instead of free kitchen goods, the hostess receives a free Botox injection from a doctor, who then offers the same to guests, but for slightly higher than the cost of Tupperware – usually $250 a pop.

The Naples Botox party was a twist on the soirees taking place in bigger metropolitan areas. Dr. Richard Maloney, a Naples plastic surgeon, decided to keep his party in a clinical setting, his office. Five women came in last Thursday afternoon and sipped coffee and ate sweets provided by Maloney. He and his staff mingled with the group in the office reception area, then each patient was treated one by one in a treatment room after filling out a medical history form and informed consent.

“As simple and effective as this procedure is, it is a medical procedure, and we don’t want that to get lost in this,” Maloney said.

Another seven women couldn’t make the actual party, but scheduled appointments to come in at other times.

Dr. Manuel Pena, a Naples plastic surgeon, said he, too, plans to host a Botox party soon.

“With the FDA announcement, I suspect you’ll a lot more people coming out for Botox treatments, and these parties are a great way to reach a number of patients in an efficient time frame,” Pena said. “The parties take some of the fear away because the atmosphere is relaxed and patients gain confidence because they see their friends do it.”

Even though the FDA approval is only for brow furrows, Botox manufacturer Allergan is working to get FDA approval for treatment of crows feet and forehead wrinkles.While doctors have been using Botox to eliminate facial wrinkles for more than five years, they say the FDA stamp of approval will buoy consumer confidence that the injections are safe.

Botox is a strain of botulimun toxin, the same toxin that causes botulism, more commonly known as food poisoning. But when injected in purified, diluted amounts, it can safely paralyze certain muscles to make them appear smoother. Botox was first approved in 1989 for treating eyelid muscle spasms and doctors discovered it also smoothed nearby wrinkles, so Botox was commonly used “off-label” for treatment of wrinkles.

The new approval now means Allergan can market Botox for treatment of wrinkles, but even without marketing, Botox was so popular that 1.6 million procedures were performed in 2001, a 46 percent increase over the previous year, according to the American Society for Aesthetic Plastic Surgery. The injections also accounted for about 20 percent of the 8.5 million cosmetic procedures performed.

Botox is most popular among women 35 to 50 years old, accounting for more than half the treatments last year, although younger people and men also are jumping on the bandwagon with nearly 14 percent of the procedures done on men and about 15 percent on people under 24 years old.At a seminar he gave at the Ritz-Carlton, Naples, two weeks ago, Maloney fielded questions about Botox and performed the procedure on a patient who volunteered.Maloney told the group the most common side-effect from the procedure is localized bruising.

There’s also a chance the muscle that holds the brow up could be weakened.One of the biggest consumer beware issues, Maloney told them, is to make sure you are getting 25 units of Botox per site, and make sure the doctor is experienced, he said.The injections last only about three months, so a person would have to come back regularly for more injections to maintain the look.

One of the biggest questions was: “Does it hurt?” To clear that up, Maloney asked patient Joyce Chad to come to the front so he could demonstrated for the audience of about 75 just how Botox injections are done.Joyce Shad, 56, held an ice pack across her eyes to numb the area before receiving the injections. Maloney, a light on his forehead shining on Shad’s face, made four small injections just beneath the skin between Shad’s eyes to get rid of her frown line, then two injections beside each eye to relax her crow’s feet.”It doesn’t hurt,” said Shad, almost a bit surprised herself.

Those in attendance couldn’t see the results because it takes three to five days for the Botox to work.After the Botox demonstrations, many in attendance lined up to ask him their own personal questions.As she waited in line, Naples resident Angela LoConte, 59, said she wanted to ask Maloney about laser and Botox treatments.”I have all these crows feet and wrinkles across my brow,” LoConte said. “The Botox looks like something I might consider. I was surprised it looked so painless and simple.”Three days after the seminar, Shad’s results were complete.”Look, no frown line at all, and the crows feet are almost completely gone. Before the Botox, you could really see the crows feet when I smiled,” Shad said. “It’s great. I didn’t have any bruising or anything. It makes me feel good because it feels a little tighter around my eyes.”