The FDA has finally approved a Botox alternative for the US market. Formerly announced as Reloxin, Medicis' Dysport is the first of a small wave of so-called "Botox killers" we have been waiting for for some time. Dysport is also the name of a drug marketed in Europe for cosmetic indications. The FDA's approval of Reloxin puts Medicis in the enviable position -- at least temporariy -- of being the first firm to break Allergan's monopoly of offering a botulinum Type A-based product for use by aesthetic practitioners in the US. In the small pond that is the plastic surgery market, this is VERY big news.

From BNET Pharma: Allergan Could Lose a Third of Botox Market With FDA's Approval of Medicis' Dysport (hat tip to Cathleen):

The FDA has approved a competitor to Allergan’s Botox. The new wrinkle-fighting drug will be marketed by Medicis as Dysport. (Medicis had intended to call it Reloxin, but apparently it’s become Dysport.) Medicis partner Ipsen will market Dysport for cervical dystonia. Medicis anticipates shipping DYSPORT(TM) for aesthetic use in the U.S. during the next 30 to 60 days.

Bloomberg has reported that compeition between Medicis and Allergan is likely to get stiff:

Reloxin may be priced 15 percent lower than Botox, helping it take almost a third of the market over time, said Gary Nachman, an analyst at Leerink Swann & Co. in New York, in a phone interview last month. He estimates annual sales of Reloxin will be $160 million by 2012.

Meanwhile, the FDA has issued its recommendation on labeling changes for Allergan's Botox, and the news ain't pretty. Botox Must Carry Strong Warning on Risks: U.S. FDA:

WASHINGTON (Reuters) - Allergan Inc's wrinkle-filler Botox and a similar product must carry a strong warning about the risks of severe complications if the injected botulinum toxin spreads in the body, U.S. regulators said today.

The Food and Drug Administration said the move followed the investigation of deaths and hospitalizations of children, most of whom were given one of the products to treat cerebral palsy. Most harm in adults occurred after treatment of spasticity or cervical dystonia, the FDA said.

The agency said "no definitive serious adverse events" related to toxin spread had been identified with dermatologic use of Botox at specific approved doses.

Deaths were reported in adults, but "it is not possible to attribute them to the botulinum toxin because the patients also suffered from complications of their pre-existing conditions," the FDA said.

Allergan shares were down 3.5 percent to $45.65 in afternoon trading on the New York Stock Exchange.

The FDA said the information must be highlighted in a boxed warning, the strongest type for prescription drugs. The action applies to Botox and Myobloc, made by Solstice Neurosciences Inc.

Allergan said in a statement the company would work with the FDA to update the label for Botox. An official at Solstice Neurosciences could not immediately be reached.

Earlier on Thursday, Medicis Pharmaceutical Corp and Ipsen announced they had received FDA approval for a rival product called Dysport. The companies said they also were asked to include a boxed warning about the risks if the toxin spreads.

It’s Monday morning review time, a good opportunity for me to plow through a backlog of news and other types of stories that I’ve bookmarked but haven’t gotten around to write-up for this blog.

Barry Eppley’s plastic surgery blog continues to impress me. He writes to educate the public and also bring up technical issues that appeal to physicians. One of his latest blog entries covers Ankyloglossia - Frenuloplasty Plastic Surgery Repair.

When it comes to anti-plastic surgery nutjobs, such as Ilena Rosenthal and her small set of minions (see here, here, here, and here) and the hyperbolic ambulance chasers at Injury Board, I know some readers who become incensed at their predilection for slinging the mud, disseminating misinformation, and general caterwauling. These “rogue sites,” though, have their usefulness. Reading their conspiracy theories, you can predict the direction the ambulance chasers will take next. This is good for recognizing the mindset of moonbats before they come to you looking for aesthetic procedures.

Speaking of wacky news, a new product claims to perform a tummy tuck using only a special cream called Rodial’s Tummy Tuck. From Plasmetic (hat tip to Phoebe):

Surgery is not the only option for people considering a tummy tuck or a breast job. A revolutionary new product, backed by aggressive marketing, clams to provide just that in a non invasive manner. Rodial’s Tummy Tuck is a miracle cream that can be applied to the midriff and the effect is apparently similar to undergoing a tummy tuck procedure. However, dermatologists and weight loss experts have laughed it off as an embarrassment to intelligent people.

Read it all.

In Laser Lipo -- One Lump, or Two?, Paula Young performs a valuable service in reviewing the myriad online postings from patients who have described their plastic surgery experiences. She regularly reads through various self-help forums in order to understand the effects of various procedures on patients.

Pumping parties, in which individuals meet privately and take turns injecting themselves with silicone and other substances in order to enhance their beauty, are becoming all the rage, according to a recent article in The New York Times.

Eva S over at RealSelf has published another winner topic that should be on the minds of all plastic and cosmetic surgeons: A medical license may not be as trustworthy as you thought.

It would seem logical that when a doctor administers fake Botox or repeatedy botches a plastic surgery procedure, they would lose their medical license. Unfortunately for consumers, even in these extreme cases of negligence, it's really hard for a doctor to actually lose their medical license.

Caught injecting fake Botox?  The doctor gets probation

Recently a Sacramento dermatologist was injecting patients with an illegal, fake Botox. Instead of losing his medical license, Dr. Timothy Rosio was placed on probation.

This wasn't the doctor's first encounter with his medical board. The Sacramento Bee reported that Dr. Rosio had been convicted in federal court of two counts involving misbranded drugs, and accused of dishonesty for failing to disclose two suspensions by the UC Davis Health System involving liposuction, ethical issues and quality of care issues.

In just under 3 years, Dr. Rosio can legally see patients again for Botox or other treatments.

Repeated botched jobs & DUI convictions

Donda West’s cosmetic surgery-related death highlighted the fact that a questionable track record can have no impact on a doctor's ability to see patients. Dr. Jan Adams, the surgeon who operated on her the day before she died, had four malpractice judgments against him (source: California Medical Board), plus two DUI convictions and a complaint for failure to provide child support. It was only after Donda West's death that Dr. Adams voluntarily surrendered his medical license.

Only the "worst of the worst' doctors lose their license.

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