A Silver Lining for Patients with French-Made PIP Breast Implants

I have previously blogged about my concerns with silicone breast implants manufactured by Poly Implant Prothese (PIP).  A quick summary:  The French company PIP used industrial-grade silicone in breast implants (rather than medical-grade silicone), thereby increasing the risk of rupture and of complications.  PIP is not licensed to sell their devices in the USA, so no American women should have been harmed by this flagrant violation of good practices.  All of my own patients have received only Mentor (Johnson & Johnson) and Allergan (formally Inamed) devices, so they need not worry.

However, my practice is quite international, and I do see many patients whose implants were not placed in the USA.  In particular, many of my patients have had surgery in Mexico, where, unfortunately, PIP has been licensed to sell their products.

Fortunately, this affair seems to have a silver lining.  The Mentor Corporation has agreed to discount their (high-quality) replacement implants for any patients with PIP devices--with a $250 American Express Gift Card.

While I have not seen many PIP patients, I did want everyone to know that I am doing everything in my power to help these poor ladies.  I will continue to search out opportunities to assist them.

Please pass along this information to any of your friends who may have had breast surgery performed outside of the USA, and who may benefit from this valuable Mentor program.

A Word About PIP/French Breast Implants

You may have read recently about safety concerns with French-made PIP silicone breast implants.  If you are one of my patients, thankfully, you are not part of this European debacle.

I am posting to reassure my patients that I do NOT use PIP implants.  If you are one of my patients, and if you have recently undergone breast augmentations or reconstructions, please rest assured that your implants were made either by Mentor or by Allergan--not by PIP.  Both Mentor and Allergan are headquartered in the USA, and neither is being scrutinized for quality or safety concerns.

So, you are OK!

How did we in the United States manage to miss the PIP (Poly Implant Prothese) controversy?  Please thank the United States government; as early as 2000, the FDA had raised concerns about the implants manufactured by PIP.  In 1996, PIP had started selling its pre-filled saline implants in the United States under a 510(k) accelerated review application that did not require the company to submit clinical trials as long as the implant was said to be "substantially equivalent" to those already on the market.  However, by 2000, the FDA required all breast implant manufacturers to submit a formal application (known as a "pre-market approval").  Three companies submitted applications - Inamed (now Allergan), Mentor (now a division of Johnson & Johnson), and PIP.  Two companies received approval:  Inamed (Allergan) and Mentor.  PIP did not.  PIP then stopped selling its pre-filled saline implants in the United States.  That is why, although over 30,000 pre-filled saline implants manufactured by PIP have been reported sold in the United States, none of the offending PIP silicone implants have ever been implanted in the United States.

Unfortunately, PIP did not self-critique upon its expulsion from the American market.  It never addressed its quality issues.  PIP has been using a cheaper industrial-grade silicone in their silicone gel breast implants, rather than medical-grade silicone.  When this information came to light, PIP was finally shut down altogether.

But damage has been done.  These cheap PIP silicone implants are much more prone to rupture and leakage than normal.  Many European health commissions have recommended PIP implant removal (and replacement with new, safe implants from either Mentor or Allergan) as a precautionary measure.  While there appears to be no evidence of a cancer link due to these implants, we can never be sure.

I would like to reiterate that the implants that I use in my practice, made by Allergan or Mentor, are FDA-approved, and have an excellent track record.  However, I do frequently see patients whose breast surgery was done in Mexico and elsewhere.  IF YOUR IMPLANTS WERE PLACED AT A FACILITY NOT IN THE UNITED STATES, PLEASE CHECK TO SEE WHETHER YOU HAVE PIP-BRAND SILICONE IMPLANTS.  If you do have them, please come and talk to me about an implant exchange.  This is very important.  Your health may depend upon it.

The 3rd Botox: Xeomin Gains FDA Approval for Cosmetic Uses

About 11 months ago, I blogged about that...

• Botox
• Dysport

...were about to get more competition from the newest kid on the block, Xeomin.  http://www.pickartplasticsurgeryblog.com/2010/08/fda-approves-xeomin-the-3rd-botox.html

On August 2, 2010, the FDA approved Xeomin for treatment for cervical dystonia (neck spasms) and blepharospasm (excessive eyelid contractions).  Late last week, on July 21, the FDA approved Xeomin for "the temporary improvement in appearance of moderate to severe glabellar lines in adult patients."

Xeomin is thus the third botulinum neurotoxin type A (BoNT-A) to enter the marketplace.  However, it is not expected to be available to physicians in the United States until the spring of 2012.

Why the delay?  I don't know.  I have called my Merz sales representative to get the scoop....

Perhaps, You Don't Need Botox Every 3 Months

New research suggests that patients getting regular Botox treatments can eventually reduce wrinkles with half as many sessions.

The research, conducted at Oregon Health & Science University, in Portland, sought to determine whether less frequent Botox treatments could provide long-lasting reduction of the frown lines between the eyebrows.  After a patient receives Botox injections every 4 months for 2 years, the frequency of treatments can be changed to 6 months with comparable wrinkle-reducing results and with high patient satisfaction.

So, if you like the effects of Botox, but if you hate having costly injections every 3 months, maybe you should reconsider.  Try to stick with Botox 3-4 times per year for a couple of years, and then you'll probably be able to reduce your Botox treatments to just twice per year.

Oh, by the way, the study also confirmed the wrinkle-preventing effects of Botox.  The study patients' wrinkles did not worsen while they used Botox.  Since they could not create wrinkles, they never formed them in the first place.  Terrific!

FDA Approves Autologous Filler

There has been a lot of hype about stem-cell therapy for facelifting.  As a Board Certified Plastic Surgeon, I find those claims comical.  Please don't fall victim to clever advertising.

However, the biologists have tremendously improved our understanding of cellular biology, and it looks like some of that basic science will legitimately hit the plastic surgery world soon.  On June 21, 2011, the U.S. Food and Drug Administration (FDA) approved the first autologous cell therapy for purely aesthetic purposes.

The product, azficel-T (laVív), is from Fibrocell Science, Inc.  According to company records, azficel-T involves a patented technology whereby fibroblasts are extracted from behind the patient's ear (via a small biopsy); sent to the Fibrocell Science laboratory; multiplied for about 3 month;s and then frozen until needed.

Over a series of 3 treatment sessions, typically 3 to 6 weeks apart, those cells are then injected back into the patient's face.  The goal is to fill in creases--such as at the nasolabial folds, which would then reduce the appearance of smile lines.

In effect, azficel-T will provide a true biological solution for deep folds and wrinkles.  The results should be gradual and natural-looking.

My opinion is that this technology is certainly interesting, and I will definitely invest the time and effort to become proficient with azficel-T.  However, I suspect that the product will not be revolutionary.  I bet that the results will not be much better than the current crop of chemical fillers (such as Juvederm and Restylane) or the current biological/stimulatory fillers (such as Sculptra).  Almost certainly, azficel-T will, however, appeal to a niche of patients who demand "natural" and who want to use their own cells (rather than a lab-produced product).

The big negative will be that patients will have to have a biopsy, wait 3 months before they get their injections, and then undergo a series of treatments (rather than just one session).  A long, drawn-out process will not be appealing in our "fast-food culture."

Also, azficel-T will likely be pricey.  No word yet as to how it will compare with Juvederm or Restylane for ~$500-500, but I suspect that azficel-T will hurt in the wallet.

Cancer Alert: Why Are You Still Tanning?

According to a new survey from the American Academy of Dermatology, more than 80% of young, white women use tanning beds or intentionally tan in the sun--despite their full cognizance of the deleterious effects of UV light.

3800 white, non-Hispanic females aged 14 to 22 years were asked about their UV exposure....

• 81% had tanned outdoors frequently or occasionally in the past year
• More than 32% reported using a tanning bed in the past year
• 25% reported using a tanning bed at least weekly

When comparing ages, 18-22-year-old women were almost twice as likely (40%) to use indoor tanning beds, compared with 14-17 year olds (22%).

Yet, most of these women recognized that tanning is not good for their skin.  Most know that UV light causes skin cancer, and certain skin cancers (like melanomas) can kill.  Public education has been effective, but education has not been enough to effect behavior change.

Looking tan is a fashion--a dangerous fashion.  Media images are obviously more impactful than physician admonishments.

Certainly, then, other measures are necessary.  More than 30 states either prohibit or require parental consent for minors who want to use indoor tanning devices. The World Health Organization has declared UV radiation from the sun and artificial light sources a known carcinogen and has called for prohibiting minors from indoor tanning.

Additionally, perhaps, there should be a waiting period for tanning bed treatments.  Or, maybe, any person interested in using a tanning bed should, just before a session, be required to watch a video expressing the deleterious effects of UV light--and there should be lots of gruesome photos.  I am not usually a fan of Big Brother, but this is an example of when people need to be saved from themselves.

Besides, white ain't so bad!  Certainly, better than cancerous.

Restylane to Be the First FDA-Approved Lip Enhancer

Late last week, an FDA-advisory panel overwhelmingly voted to recommend approval for Restylane's use as a lip enhancer.  While the whole FDA still needs to make a final decision, they typically accede to the advisory panel.

Of course, using Restylane (or its competitor Juvederm) for lip enhancement is nothing new.  Lindsay Lohan, Lisa Rinna, Lara Flynn Boyle, and Meg Ryan (among others) have each demonstrated Restylane's...er...effectiveness.

Well, those are poorly chosen examples!

Lip enhancement with Restylane and Juvederm doesn't have to be overdone, unnatural, and ridiculous.  Actually, I frequently use Restylane and Juvederm to enhance lips....

• to minimize "smoker's lines"
• to accentuate pouts and pillows
• to restore fullness that has disappeared after weight loss or with age
• to create voluptuousness when God made your lips too thin

Very soon, expect to see a lot of appropriate examples of lip enhancement on television and magazines.  FDA approval will allow the distributors of Restylane to advertise their product!

6 International Consensus Statements on Plastic Surgery Controversies

The International Confederation for Plastic, Reconstructive, & Aesthetic Surgery (IQUAM) recently published consensus statement regarding controversies in plastic surgery.  I thought that my readers might find this list interesting...

• Multiple "medical studies have not demonstrated any association between silicone-gel filled breast implants and carcinoma or any metabolic, immune, or allergic disorder."

Translation:  Silicone breast implants are safe.  They do not cause breast cancer.  They do not cause lupus, rheumatoid arthritis, psoriasis, etc.

• "Silicone-gel filled breast implants do not adversely affect pregnancy, fetal development, breast-feeding or the health of breast-fed children."

Translation:  If you have had silicone implants, feel free to breast feed your babies.

• "Phosphatidylcholine has been used for prevention and treatment of fat embolism for many years, but it is currently being used 'off label' for dissolving fat in aesthetic applications.  Data concerning the efficacy, outcome, and the safety of its use for aesthetic indications in subcutaneous tissue have not yet been established. Further basic science and clinical trials are needed."

Translation:  "Lipodissolve" and "LipoZap" injections have not been shown to be either effective or safe.  While I know that everybody wouldn't mind getting rid of a "love handle" or two, don't submit to any unproven injection technique.  Liposuction remains the gold standard.

• "Botulinum toxins (BTxA's) have been used extensively for aesthetic purposes. BTxA's in high dosages have been used in various therapeutic clinical applications with minimal reported significant adverse effects. Current clinical data confirm the safety of BTxA’s for aesthetic indications when used by experienced doctors under sterile office environment. Patients should be provided with detailed information, and a signed informed consent should be obtained prior to performing the procedure."

Translation:  Botox and Dysport kick ass!

• Regarding injectable fillers...  "Today, more than 35% of the procedures performed by plastic surgeons are no longer purely surgical.  The use of resorbable substances is preferable to the use of nonresorbable fillers, as recommended by many national health authorities or academic societies....Permanent fillers (excluding autogenous tissue) can give a definitive correction, but have been reported to be associated with long-term, irreversible complications and should be used with extreme caution."

Translation:  Fillers are increasingly popular.  Choose one of the common resorbable fillers (such as Restylane, Juvederm, and Radiesse) rather than a permanent filler (such as Artefill or liquid silicone) because the temporary fillers are safer.

• "IQUAM urges governments to pass legislation to prohibit the use of non-certified products and to protect patients from untrained physicians and nonmedical personnel injecting or implanting materials for various indications."

Translation:  Board Certified Plastic Surgeons wish that patients were protected from poorly trained injectors.  However, there are few laws that limit the practices of doctors and nurses, many of whom suck.  Make sure that your injector is certified by an appropriate specialty board.

(By the way, the only board recognized by the American Board of Medical Specialties to certify phyisicians in the practice of plastic surgery is the American Board of Plastic Surgery.)

Tax Deductions for Cosmetic Surgery: Legal?

Maybe.

According the IRS, if you itemize your deductions on Form 1040, Schedule A, you may be able to deduct expenses you paid that year for medical care for yourself, your spouse, and your dependents.  Specifically, you may deduct the amount by which your total medical care expenses for the year exceeds 7.5% of your adjusted gross income.

Technically, deductions are allowed only for expenses primarily paid for "the prevention or alleviation of a physical or mental defect or illness."  The IRS specifically states that you may not deduct "most cosmetic surgery."

However, many of the surgeries that I do are both cosmetic and functional.  Examples:

• Breast reductions:  Not only are the breasts lifted and made cuter, but also the removal of the excess weight greatly relieves neck, upper back, and shoulder pain.
• Breast lifts:  Elevating the breasts (so that a woman fails the "pencil test") diminishes sweating and rashes in the folds beneath the breasts.
• Tummy tucks:  Certainly, flattening the tummy is the primary goal, but also removing the apron of excess skin diminishes sweating and rashes.
• Blepharoplasties/Eyelid surgery:  Trimming the excess skin and fat from the upper eyelids creates a more rested, awake appearance, and also improves sight by ridding the patient of tissue that directly obstructs the visual fields.

So, for many cosmetic surgeries, I could honestly write a letter to the patient's accountant stating that the surgery alleviated a physical ailment, and, therefore, consideration should be given towards a tax deduction.

New Weight Loss Drugs NOT Safe, FDA Rules

As obesity rates continue to rise, the need for a safe and effective weight loss drug is urgent.  Yet, 3 promising therapies have been halted in the pipeline this past year.

The FDA has declined to approve the diet drug Contrave.  Instead, the FDA has asked its manufacturer, Orexigen Therapeutics, to conduct a study "of sufficient size and duration" to examine the potential heart risks of the drug, which is a combination of naltrexone and bupropion HCL.

Last December, a majority of members of the US Food and Drug Administration (FDA)'s Endocrinologic and Metabolic Drugs Advisory Committee gave a thumbs-up to Contrave, something they had not done for two other diet drugs they had reviewed earlier in the year.

Lorcaserin (Arena Pharmaceuticals) and phentermine/controlled-release topiramate (proposed name: Qnexa, Vivus) were the other two proposed diet drugs not recommended by the FDA advisory committees reviewing the evidence for both drugs last year.  The FDA has subsequently rejected their marketing applications, asking for more data.

Yet another diet drug, sibutramine (Meridia, Abbott Laboratories), was yanked from the market earlier in the year due to concerns about its cardiovascular safety.

Had Contrave been given the green light, as many predicted following the advisory committee's deliberations, it would have been the first new diet drug on the US market in the past decade.

Dr Sanjay Kaul (Cedars Sinai, Los Angeles, CA), one of the seven FDA panelists who voted against Contrave's approval back in December 2010, said the FDA, which more often than not follows its advisors' recommendations, made "the right decision" and not a very surprising one.

"I went on record saying that the 13 to 7 vote is going to create a buzz that is not going to accurately reflect the tepid enthusiasm for this drug. Even the individuals who voted for the drug were not very enthusiastic for it."

In fact, Kaul points out, ambivalence and mixed feelings were a hallmark of the Contrave panel discussions:  three panel members who voted to recommend approval also voted for preapproval studies, while two who voted for postapproval studies also voted against approval.

The bottom line for Kaul was the fact that the modest weight loss achieved with Contrave was unlikely to translate into tangible morbidity/mortality benefits to offset any risks.  "You can never establish safety in preapproval assessment, so there is always some degree of risk that you are willing to trade off, providing the benefit is large enough. And in my opinion, the benefit [with Contrave] was very modest," Kaul said.

So, what are obese patients to do?  Since it doesn't look like there will be any pharmacological solutions in the near future, I would recommend seeing a bariatric surgeon for gastric bypass or laparoscopic gastric band.  While I don't offer those procedures in my own practice, I have been impressed with their efficacy and relative safety.