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.

Plastic Surgery After Weight Loss Works

Before:  48-year-old woman who lost 160 lbs. after bariatric surgery and after becoming an avid cyclist

After a tummy tuck.

Let's be honest.  We have all seen somebody who has had plastic surgery, and whom we can hardly tell whether there is a difference.  We squirm with that facelift patient, "Um. Er.  You look...er..better(?)"  We try our best to wriggle out of the discussion.

I never feel that way with my weight-loss patients.  Abdominoplasties, body lifts, brachioplasties, breast lifts, etc., on bariatric patients typically create dramatic improvements.  The results are not subtle.

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.

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.

Breast Lymphoma Associated with Implants: Worth Being Scared About or Scare Tactic

On January 26, 2011, the U.S. Food and Drug Administration warned about a potential association between anaplastic large cell lymphoma (ALCL) and breast implants.

• If you have breast implants, should you be worried?
• Should you call your plastic surgeon to have them removed?

No & No.

ALCL is considered a rare but aggressive type of lymphoma.  Only one in 500,000 American women develop ALCL.  It is even rarer in the breast itself--3 in 100 million women (without implants).  Fortunately, most forms of ALCL are treatable with a cocktail of chemotherapy.

Over the past two decades, implants have not been definitively linked to rheumatalogical diseases, breast cancer, leukemia, or lymphoma.  On the contrary, the safety of breast implants has been proven in a number of North American and European studies.

Like any foreign body, implants elicit a scar capsule.  The body doesn't know what the artificial substance is; the immune system cannot break it down and destroy it.  So, the body creates scar around the implant.  That scar is known as a capsule.

In some capsules, cells have been identified that look awfully similar to ALCL--34 identified cases out of an estimated number of 5 to 10 million women with breast implants.  However, none of those patients has subsequently developed the traditional constellation of findings consistent with ALCL.  None have died of lymphoma/cancer.

Moreover, surgical removal of the scar capsules has definitively removed all evidence of the abnormal cells.  No chemotherapy was ever necessary.

This is awfully strange.  Surgery is not at all effective for traditional ALCL.

So, did those 34 women ever have ALCL or a variant of ALCL?  Or did they have funny reactions to the implants in their scar capsules, which looked a lot like ALCL, but which were never ALCL in the first place?

A shark looks like a dolphin.  They are both sleek and grey.  They both swim and hunt fish.  But they are awfully different.

ALCL is clearly a shark.  It's a bad actor.  But the implant-ALCL (if I should even call it that) may be a dolphin.  It can look scary at first glance, but, in fact, it may not dangerous at all.

If you have breast implants, there is no need to change your routine medical care and follow-up.  ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants.

What to remember to do: 

• Monitor your breast implants.
  • If you notice any changes, contact your health care provider promptly to schedule an appointment.
  • The (supposed) cases of breast-implant-associated ALCL all presented with the late onset of symptoms such as pain, lumps, swelling, or asymmetry. 
• Get your radiologic imaging.
  • Routine mammograms.
  • If you have silicone breast implants, do consider periodic magnetic resonance imaging (MRI) to detect ruptures.  (The FDA suggests that patients with silicone breast implants should obtain MRIs after 3 years and then every 2 years thereafter.  Personally, I think that this is excessive, but you might decide for yourself what is appropriate.)
• Don't panic.  The FDA may be acting overly cautiously.  Just be aware.