More Bogus Botox in Florida

I think Botox is terrific. I really do. But like any powerful tool, it's critical that it be administered by someone who's properly trained...and actually licensed to practice medicine!

Just last week I received this email alert [see copy below] from the Florida Board of Medicine about a man in Coral Gables, Florida who has been injecting people with Botox in his home (!). The problem? He's not a doctor...or any other kind of licensed practitioner, for that matter:

FOR IMMEDIATE RELEASE Contact: Communications Office

August 11, 2008 (850) 245-4111

FLORIDA DEPARTMENT OF HEALTH INVESTIGATION LEADS TO ARREST IN CORAL GABLES

TALLAHASSEE— The Florida Department of Health’s (DOH) South Florida Unlicensed Activity (ULA) Unit announced that their joint investigation with the Coral Gables Police Department Special Investigations Section (CGPD) has led to the arrest of Juan J. Aguirrechu in connection with the unlicensed practice of medicine, a third degree felony and punishable by up to five years in prison.

A CGPD investigation that was initiated from an anonymous tip indicated Aguirrechu was practicing medicine from his residence located at 5627 Granada Blvd. in Coral Gables. Specifically, it was alleged that Aguirrechu was representing himself as a doctor and was providing Botox injections to “patients” he would see at his home. A ULA investigation determined that Aguirrechu holds no form of licensure from the Florida Department of Health. The joint investigation ultimately led to the issuance of an arrest warrant. On Tuesday, August 5, 2008 CGPD detectives contacted Aguirrechu at his house and took him into custody without incident.

DOH has several resources to combat unlicensed activity:

· Consumers are encouraged to use DOH’s Web site www.flhealthsource.com where they can conveniently view the license information of their health care practitioner.

· Complaints may be filed anonymously by completing and mailing the complaint form on the DOH Web site or calling 1-877-HALT-ULA to have a form mailed to you.

The Florida Department of Health’s (DOH) unlicensed activity program protects Florida residents and visitors from the potentially serious and dangerous consequences of receiving medical and health care services from an unlicensed person. DOH’s Division of Medical Quality Assurance (MQA) investigates and refers for prosecution all unlicensed health care activity complaints and allegations. The unlicensed activity unit works in conjunction with law enforcement and the state attorney’s offices to prosecute individuals practicing without a license. In many instances, unlicensed activity is a felony level criminal offense. More importantly, receiving health care from unlicensed people is dangerous and could result in further injury, disease or even death.

The mission of the Department of Health and MQA is to promote, protect and improve the health of all people in Florida. Working in conjunction with 22 boards and seven councils, MQA regulates six types of facilities and more than 40 health care professions. MQA evaluates the credentials of all applicants for licensure, issues licenses, analyzes and investigates complaints, inspects facilities, assists in prosecuting practice act violations, combats unlicensed activity and provides credential and discipline history about licensees to the public. Visit http://www.doh.state.fl.us/mqa/ for additional information about MQA.

You can read the news reports about this guy here, for example.

Here are some questions that come to mind, though, that aren't answered in the email or the news reports:

• Was it even real Botox? Botox Cosmetic can only be legally purchased through Allergan, the company who manufactures Botox here in the U.S. Allergan requires proof of our medical licensure before they'll open an account. Recall that in 2004 several people in south Florida ended up on ventilators with acute botulism after being injected with an unapproved and illegal bulk research-grade botulinum toxin.
  
  On the otherhand, we routinely receive offers (via fax) from companies outside the U.S. to purchase cut-rate supplies of Botox, Juvederm, Restylane, etc. much less expensively than by ordering through the authorized distributors. This, too, is illegal under FDA rules (despite claims to the contrary on those companies' web sites). I presume that further investigation will uncover Mr. Aguirrechu's source of "Botox."



• Why in the world would you trust a guy to inject your face with Botox when he doesn't even have an office? Shouldn't it raise a few red flags when he's treating people out of his home? [It's a nice home, by the way, valued at just under a million dollars] Have gas prices gotten so high that people need to save a few bucks on Botox by going to this guy? (I'm presuming he was inexpensive, but I haven't found any news reports that have uncovered what he was charging).
  

This guy, of course, isn't the first person to illegally practice and he won't be the last, unfortunately. Who can forget, for example, the recent reports that Priscilla Presley had been the victim of an unlicensed practitioner who injected her face with industrial-grade silicone?

As usual, though, caveat emptor and please be sure to check into the credentials of the person wielding the needle or the knife.

Artefill and FUD?

One of my favorite products for minimally-invasive, in-office cosmetic procedures is an injectable filler called Artefill. It's a product used for the correction of deep facial folds, such as smile lines, and for contouring other areas of the nose and face as well. It's chief advantage is that it is permanent. So I was surprised to find that a few of my colleagues across the country have been suggesting that Artefill is a not such a good product.

I couldn't disagree more. Now, reasonable physicians will disagree about treatments and techniques from time to time. Our regional and national meetings are filled with such debates and discussions. The problem here, however, is the way in which Artefill is often being attacked—through "FUD."

"FUD" is a marketing term that stands for "Fear, Uncertainty, and Doubt." It's a technique used to attack a competing product or service, often when there is no real basis for the attack. So lets address the most common claims head on:

.............................................

Claim 1: "This product is too new to know what it's long-term safety is."

Answer: Although Artefill is new to the United States, its sister product, Artecoll, has been used in Canada since 1998 (nearly ten years ago) in thousands of patients. I, myself, first treated patients with Artecoll in 1999 during my fellowship training in my home town of Toronto and have been very pleased with its performance. And Artecoll's predecessor, Arteplast, was used in Eupore earlier still. And PMMA (poly-methyl-methacrylate), the chief component of Artefill, has been used in other applications in humans for decades. This is not to say that it has no risks. Local complications of nodule formation and other skin reactions are known risks and are somewhat technique dependent.

But the broader point is that new products, techniques, and technology are constantly being introduced and refined. That doesn't mean that I jump willy-nilly on every new thing that comes down the pike (far from it), but do we really want to practice medicine the way it was done decades ago? Plus, long-term data from the Canadian experience with Artecoll has been published in peer-reviewed medical journals reviewing just such risks of complications.¹ Similar data exists for the U.S. experience during Artefill's FDA-approval process.


Claim 2: "It's permanent. I'd have to always worry about the long-term changes to my patients' faces."

Answer: Of course! But as a facial plastic surgeon I routinely have to take that into consideration. Whenever my colleagues or I perform surgery (e.g., a rhinoplasty, an eyelid lift, or an otoplasty) we are creating permanent changes that have to take into account long-term changes. This is why it's serious stuff and why I harp on having the right training to do these cosmetic procedures.

Now, the cynical side of me has another theory about why some practitioners are opposed to using something permanent on their patients. Permanent products don't require continual re-application (or continual payments to the doctor). I sometimes wonder if those patients are simply seen as an annuity that will keep paying dividends year after year!

Dr. Arnold Klein, for example, a dermatologist in Beverly Hills, has asserted that Artefill will "destroy" the soft-tissue augmentation field. But consider that Dr. Klein has been paid for years to consult for Allergan and Medicis, makers of the competing and non-permanent products of Juvederm and Restylane, respectively. [FYI, Juvederm and Restylane are also excellent products, and I use them in areas of the face that are not as well suited for Artefill, such as lip augmentation and fine wrinkle correction]. And in case you're wondering, no, I do not have any relationship with any of these companies.

Claim 3: "There's too much guesswork in the volume of Artefill needed."

Answer: This claim, I think, simply comes from ignorance of the proper technique for this product. Artefill is not placed the same way as other fillers. Full correction with Artefill is achieved gradually over two or three (maybe more) sessions separated at least two months apart. I counsel patients that perfection lives at the edge of a cliff. We want to ease toward that goal, not rush toward it where we might overshoot it. I purposely under-correct facial folds with Artefill since it's easy enough to add more, but difficult to take it away.

.............................................

In summary, Artefill is just another tool in our armamentarium for the correction of facial folds and other contour problems of the face. It is not for everyone. And like all procedures in facial plastic surgery, there is risk involved. To put it in perspective, I would put Artefill below surgery in terms of risk, yet above other temporary fillers like Radiesse, Restylane, and Juvederm.

Hopefully this information will be helpful to you as you consider your choices with injectable fillers and other cosmetic procedures.

---

¹Bagal A, Dahiya R, Tsai V, Adamson PA. Clinical experience with polymethylmethacrylate microspheres (Artecoll) for soft-tissue augmentation: a retrospective review. Arch Facial Plast Surg. 2007 Jul-Aug;9(4):275-80.