Breast Enhancement

February 10, 2012

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.

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February 06, 2012

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.

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April 21, 2011

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.)

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February 07, 2011

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.

 

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February 02, 2011

Warning: "Awake" Anesthesia is Dangerous

Reprinted from SELF magazine, the following is an excellent article by Sabrina Rubin Erdely.

Paulette Hacker couldn’t stop screaming.  Lying on her side on a gurney, wearing only a bra and panties, she felt as if she were being stabbed again and again.  In a way, she was.  Through incisions in her upper back, a stainless steel tube called a cannula was suctioning out her excess fat.

“Please stop! You’re hurting me!” she cried to her doctor.  Because although Hacker’s body was limp and her mind bleary from an unknown combination of drugs she’d been given through pills and a gas mask, the 38-year-old was awake part-way through the second day of liposuction on her back, underarms, abdomen, hips and neck.  That was the whole point:  She was undergoing the new and aggressively marketed Awake cosmetic surgery, which is performed under local anesthesia.

“You can’t scream, Paulette,” a gruff voice answered her.  Hacker hazily realized that the voice did not belong to her doctor; the man performing her operation was a stranger whom Hacker would later discover was a physician’s assistant.  According to Hacker, whose experience is also detailed in a Los Angeles Superior Court complaint, she could see people coming and going into the “operating room”—more like an oversize exam room—at the Rodeo Drive office of Craig Alan Bittner, M.D., a “liposculpture” practitioner in Los Angeles.  (Through his attorney, Dr. Bittner strongly denies all of Hacker’s allegations.)

“Move her into the TV room—she’s making too much noise,” a confused and terrified Hacker heard another voice say.  Her gurney was rolled down the hall and into a second room, where she could see the assistant jab her while he watched a basketball game playing in the background on a wall-mounted television. The volume was cranked up loud enough to drown out her cries.

After the five-hour operation, Hacker says the assistant and an office clerk yanked her to her feet and squeezed her into compression garments. Dazed and sobbing, she struggled into her clothes and found herself face-to-face with a beaming Dr. Bittner. The doctor gently asked why she was crying, she says.  Then he maneuvered her beside him and told her to smile for a photo.

"Awake" marketed as cheaper, more medically advanced

Hacker had been excited to fly down two days earlier from Sacramento, California. The stay-at-home mom weighed 233 pounds and was trying to slim down; she’d lost 22 pounds on her own through diet and exercise—mostly jogging—and now felt she could use some help.  But she’d never had elective surgery before and feared having general anesthesia.

Surfing the Web, Hacker had discovered the "Awake" procedure, which was advertised as a cheaper and more medically advanced alternative to lipo—and, for those inclined, to abdominoplasty and breast enhancement, too.  The price was right: Awake lipo with Dr. Bittner would cost only about $700 for each body part, versus about $3,000 if she had regular plastic surgery.  She found it comforting that the lipo would be performed in a doctor’s cozy office, not in an intimidating outpatient surgical center or hospital.  Best of all to Hacker, Awake ads promised that patients would remain lucid throughout the operation and even be able to interact with their doctor.  “I liked the idea that I’d be awake and in control,” Hacker remembers.  “The surgery really looked like it was for me.”

Unfortunately, the procedure may not have been designed to meet her needs, but rather the doctors’.  “The reason for the ‘awake’ portion of it has nothing to do with improving patient comfort,” says Joseph M. Gryskiewicz, M.D., of Minneapolis, chair of the emerging-trends committee of the American Society for Aesthetic Plastic Surgery (ASAPS).  “It has to do with doctors not needing to involve an anesthesiologist.” General anesthesia is expensive, and the specialists who provide it prefer to work in hospitals or clinics that have met high safety standards.  Awake surgery has become a way for doctors who lack hospital privileges—but who want to cash in on the plastic surgery market—to exploit a loophole by performing the operations in the privacy of their offices.  “This is just a gimmick by people who can’t operate their way out of a wet paper bag,” Dr. Gryskiewicz argues.

Hacker had chosen Dr. Bittner’s medi-spa after studying his website, which showcased his Johns Hopkins education, testimonials, and pictures of smiling patients beside the tall, tan doctor. Hacker checked to make sure Dr. Bittner was qualified, and there it was: “board-certified.” She didn’t realize that he was a board-certified radiologist. A non-plastic-surgery background is the norm for Awake practitioners, who tend to be family physicians, OBs, ophthalmologists, pathologists—any doctor willing to shell out up to $7,000 for two-day training courses held around 30 times a year by a group of recently formed professional associations.

It’s all emblematic of a growing problem of amateurism in the plastic surgery field, warns Michael F. McGuire, M.D., a director of the American Board of Plastic Surgery, the group that certifies plastic surgeons. In Southern California, 40 percent of liposuction practitioners had no training in the procedure before entering practice, according to a 2010 study in Plastic and Reconstructive Surgery by surgeons at Loma Linda University Medical Center in California. The study found that the most numerous providers of lipo after plastic surgeons were otolaryngologists—ear, nose and throat doctors. And a 2008 review of liposuction-related fatalities in Germany concluded that in cases in which patients died, “lack of surgical experience was a notorious contributing factor,” especially when it came to doctors’ failing to identify complications.

Breast augmentation takes that risk to an even higher level, Dr. McGuire says, because of the host of emergencies that could arise, including blocked airways, blood pressure changes, or collapsed lungs.  And full tummy tucks are the most invasive of all, risking pulmonary embolism and abdominal perforation; Dr. McGuire calls it “inconceivable that anyone would do such a major procedure under anything less than a light general anesthesia.”  He cites Awake surgery as part of a disturbing trend of non–plastic surgeons attempting procedures that have not been thoroughly tested—such as the not-yet-FDA-approved “stem cell face-lift,” and Macrolane injectable breast enhancement—and unabashedly touting them to the public as the Next Big Thing.  “Awake surgery is a carnival sideshow event,” Dr. McGuire says. “Your life could be at stake with some of these kooks.”

Patients alert and have input, but also agony 

An Awake breast-implant surgery in the Plano, Texas, office of Jeffrey C. Caruth, M.D., often starts with a small dose of 5 or 10 milligrams of Valium, to relax the patient. “If they take too much sedative, they’re going to have trouble picking out a size,” says Dr. Caruth, a board-certified ob/gyn who has performed more than 200 Awake breast jobs since his training course in May 2008 (as well as 1,000 Awake liposuctions, charging up to $5,000 per surgery). Using a thin needle, Dr. Caruth injects each breast with a small amount of the anesthetic fluid lidocaine. When the area numbs, he makes his first incision. There’s no anesthesiologist and, unlike with IV-administered “twilight sedation,” no drip that can be adjusted to render a patient unconscious if she’s in pain.

“They’re totally alert,” Dr. Caruth says. “It’s actually a lot of fun; we play music and talk.” He says his patients feel nothing as he uses a cannula to infiltrate both breasts with tumescent fluid—a solution of saline, lidocaine and epinephrine—and makes more incisions. Next, they feel pressure and pulling as he stretches the skin and muscle to create a pocket under the muscle large enough for the implants. Then comes the climactic moment: The patient’s gurney is ratcheted upright so she can face a mirror and see her chest inflated with temporary sizers. The doctor ushers in her partner, family or friends to help her decide if she’s happy with her new silhouette before proceeding with the implants.

This is the driving reason women choose Awake breast surgery, according to Dr. Caruth.  “They want to have input. When you go shopping, you don’t take something off the rack, throw it in the sack and go home. You try it on first,” he points out.  “Women are picky.  It’s like shopping for a new dress or a pair of shoes.”  He consults with patients before surgery about what’s feasible, but the ultimate decision comes while they’re under the knife.

A patient’s autonomy—her ability to exert control over her own body—is a huge selling point, emphasized again and again on the websites of Awake practitioners.  But the idea of asserting your rights on the operating room table is misguided at best, says Diana Zuckerman, Ph.D., president of the National Research Center for Women & Families. “A woman lying there is not in any position to be giving advice to the surgeon,” she exclaims.  “To make it sound like empowerment? The mind reels.”

For one thing, when a patient is sedated with Valium or Percocet, her judgment is clouded, making her more prone to irrational decisions or to being overly influenced by the onlookers, says Herluf Lund, M.D., a plastic surgeon in St. Louis who has researched the safety and design of breast implants.  Dr. Lund watched a video of an Awake breast surgery at an ASAPS conference—and says the roomful of doctors was aghast.  “The patient looked as if she’d had about 10 stiff margaritas” as she contemplated her reflection and—at her doctor’s urging—agreed to go up a size, he recounts.

Dr. Caruth says his patients are completely lucid because of his insistence upon minimal sedation—about half of his patients take no Valium at all—and that he’s had only two patients who wanted do-overs, both to go bigger.  “I know people who say they do Awake breast augmentation and then slam the patient with narcotics,” he says.  “That’s not the case here.”  But even among patients who aren’t sedated, the time to make reasoned decisions is before surgery, Dr. Lund argues.  The operating room is not a shopping mall, after all; if you regret your impulse purchase, you can’t easily go back and return it. “In the consultation room, the C-cup might have made more sense for your body and your life, but in the operating room, you might say, ‘Give me the D!’” Dr. Lund says, adding, “Later, if you’re not happy, the doctor can say, ‘Well, I gave you what you wanted.’”

Another Awake premise is that patients are smart to avoid general anesthesia, which causes one death per 200,000 to 300,000 anesthetics given, the Institute of Medicine estimated in 2000. But the large volume of lidocaine used during an Awake surgery poses its own risks. “The amount of local anesthesia needed to anesthetize both breasts comes close to the toxic level,” says Dr. McGuire, who is also immediate past president of the American Society of Plastic Surgeons (ASPS).  Lidocaine has not been extensively studied for breast augmentation, but plastic surgeons say a limit of 35 mg to 50 mg per kilo is wise.  Dr. Caruth says he uses about half this amount.  But in reviewing more than a dozen cases of Awake surgery gone wrong, Dr. McGuire says patients got more than the limit—and warns that a lidocaine overdose can kill.  The idea is that a high dose is safe in Awake surgery because it’s injected into fat, which, having fewer blood vessels than muscle does, is slower to absorb anesthetic.  On the other hand, “that slow absorption could mean you’re just delaying peak toxicity,” says Keith J. Ruskin, M.D., professor of anesthesiology at the Yale University School of Medicine.  “So theoretically, you could have someone on her way home from surgery, and complications like seizures and heart arrhythmias could arise.”

Without an anesthesiologist present, patients can also end up in agony. Dr. Caruth says he’s able to resolve discomfort with an extra squirt of tumescent fluid.  But “you don’t want people with a low threshold for pain,” he adds.  If a patient remains uncomfortable after a doctor has already maxed her out on lidocaine, an Awake practitioner is left with only two options: Halt the surgery, or grimace and carry on.  Responsible doctors would do the former; Dr. Caruth says he’s only once had to cut a surgery short.  But not all surgeons act responsibly, Dr. McGuire says, and if patients were to writhe in pain at the wrong time, it could spell disaster.  “The stories are just hair-raising,” he says.  “As a surgeon, I don’t want to be operating on screaming people.”

Awake doctors aren't trained in plastic surgery 

After her painful procedures, Hacker returned home bandaged, swollen and sore. “I hurt so much, I couldn’t function,” she says. Her entire body swelled out of control despite her wearing a pressurized garment for eight weeks, and she had neck and back pain so wrenching that she couldn’t lift her young daughter for the next year and a half.

The more facts Hacker learned about her physician, the more disturbed she became. Three other patients had come forward, alleging their Awake liposuction was performed not by Dr. Bittner but by his office manager—a woman with no medical license who was also his girlfriend—and that they emerged injured and disfigured. Those suits were settled or withdrawn. But Dr. Bittner still faces a felony charge for aiding and abetting the practice of medicine without certification, as well as a civil suit brought by Hacker. His lawyer, Benjamin Gluck of Los Angeles, notes that his client has “hundreds and hundreds of satisfied patients” versus “a few unhappy patients who have retracted their more colorful accusations under oath.” Given this, Gluck says he strongly believes the criminal case will resolve in the doctor’s favor.

Hacker also discovered that no doctor should have given her lipo in the first place.  It is inappropriate for obese patients because of their higher risk for complications and because surgeons can safely remove only about 5 pounds of fat, Dr. McGuire says.  Worse, experts say, doing multiple sessions of lipo on many body parts over sequential days—common among Awake surgeons—is far outside the norm and vastly increases the dangers.  When she shared post-op reports from Dr. Bittner’s office with another physician, Hacker learned her blood pressure went so high during the procedure she could have had a stroke.  “This was all about greed, not about taking care of patients,” she says.

The main organization pushing the Awake-training gold rush is the American Academy of Cosmetic Gynecologists in Tucson, Arizona—a group with an official-sounding title, but one that is actually open to any ob-gyn willing to pay $300 in dues.  Founded seven years ago, the “academy” quickly attracted so many other specialists clamoring to join that other organizations sprouted up to accommodate them—the National Society of Cosmetic Physicians, which now boasts 1,200 members, as well as the American Academy of Cosmetic Family Medicine and the American Academy of Cosmetic Dermatologists.  A fifth group, the National Society of Cosmetic Plastic Surgeons, contradicts its name by asking only that applicants be practicing “physicians,” not plastic surgeons.  (In contrast, doctors hoping to join more prestigious, long-standing societies like the ASPS and the ASAPS must be board-certified in plastic surgery, engage in continuing education, and be sponsored by current members.)

In a surprise twist, reporting revealed that despite their various names, all five Awake groups seem to be the same organization, listed at the same Tucson address, sharing phone numbers and faculty. An employee who answered the phone refused to reveal the groups’ leadership, saying only that the director’s name was “Brad” and that the groups declined to comment.

The linked organizations offer two-day courses in Awake liposuction ($5,000), tummy tucks ($7,000) and breast augmentation ($7,000).  Among the instructors is Anil Gandhi, M.D., a general surgeon in Cerritos, California, who is not board-certified in any field.  Dr. Gandhi’s workshop—which includes lectures on start-up costs, promotional materials and handling the dissatisfied patient—is complete after 22 hours.  It takes more than five years in a residency program to train surgeons to do breast augmentation.

The threat to patients is not theoretical:  After a 37-year-old Florida woman went into shock and died after undergoing lipo with a doctor trained only by short courses designed for gynecologists, the state board of medicine found that “these courses do not provide adequate training to develop the proper surgical judgment” on who is a good candidate, what form of anesthesia is safest for her and how to avoid and react to complications.

Many surgeries done in unsafe facilities

 Not only do Awake practitioners work outside their area of expertise, but many operate in facilities with few safety standards.  Most facilities outfitted for moderate anesthesia and up are accredited by one of the major nonprofit organizations that oversees safety and doctor training.  But because Awake practitioners use only local anesthesia, they often skip accreditation, too.  “Do they know anything about sterility, about occupational health and safety standards, about infection control?” asks Lawrence S. Reed, M.D., immediate past president of the American Association for Accreditation of Ambulatory Surgery Facilities in Gurnee, Illinois.  “Because they’re not accredited, there’s no way of knowing what goes on in their offices.”

Unless, of course, something goes wrong—as happened in the office of Sean Su, M.D.  Trained as a family physician, Dr. Su opened a clinic in Las Vegas called the Skin + Body Institute and advertised a “Makeover Wish” contest, the winner of which would get free Awake implants and then shill for his website.  The prize went to a 29-year-old who explained in an entry essay that she suffered from low self-esteem, partly due to marital problems.

State authorities would soon come to call her Patient A.  During her surgery in April 2009, Patient A experienced “significant pain and anxiety” for eight grueling hours, according to the Nevada State Board of Medical Examiners, which investigated her complaint.  She was slow to heal—and seven weeks after surgery, her right implant started to pop out of its incision, says Douglas Cooper, executive director of the board.  Dr. Su then performed yet another painful eight-hour Awake surgery, during which he washed the infected breast pocket, then returned the implant to her chest—right along with any bacteria that might have been left clinging to the implant.

Little surprise, then, that Patient A was admitted two weeks later to Sunrise Hospital for emergency surgery for a breast infection.  As the surgeons removed her implants, they were shocked by what they saw.  According to the investigators’ preliminary findings, Dr. Su had created a pocket too small for the implant.  His incisions were “jagged and uneven” and three times longer than appropriate.  And he’d left behind an “inexplicable mass of sutures” along the tissue of her right chest wall, increasing the odds for infection.

The board also discovered a second patient of Dr. Su’s with a similar complaint: a 25-year-old who’d also undergone an eight-hour Awake breast surgery, followed by serious infection.  Investigators found an unsterile clinic with a canister of days-old liposuction waste left in a procedure room and expired tools and medications, including the lidocaine used for Awake procedures.

In March 2010, the board of medical examiners found Dr. Su guilty of malpractice, keeping inaccurate records and trying to deceive board staff. Yet his penalty didn’t seem that bad. He had to reimburse the cost of his $25,000 investigation, pay a $4,500 fine and serve out 18 months’ probation, during which he is barred from practicing or supervising cosmetic procedures.  He is free to once again do family medicine and told self in an email that he has fixed the conditions in his office and, when his probation ends, he plans to restart his aesthetic practice, too:  “I had no other alternative but to accept their agreement due to lack of finances for a prolonged defense with a biased medical board” driven by “antiquated physicians not up-to-date with knowledge in the advancement of safer treatments.”  There is a tendency for plastic surgeons to “protect their turf from outsiders,” Dr. Su added.  “As always will be the case, such pioneering physicians as myself will be criticized when known complications occur and will thus be judged harshly and unfairly.”

A few state medical boards have become concerned enough to try to stem the tide of doctors’ “scope drift” into cosmetic surgery.  After three liposuction patients died in the care of an internist in Anthem, Arizona, that state’s board was the first to draft guidelines reminding doctors that, upon expanding their practices into new areas, they need to be competent in those areas, says the board’s executive director, Lisa Wynn.

In North Carolina, the medical board suspended indefinitely the license of an ear, nose and throat doctor who did a series of substandard plastic procedures and is finalizing a policy that could result in discipline for doctors who venture too far from their expertise.  Previously, a rash of liposuction deaths in Florida led to more stringent rules for office surgery.  These rules make a small step in the right direction but still rely heavily on doctors’ willingness to adhere to the honor code.  With little oversight, “it’s a buyer-beware situation,” Dr. McGuire says.

Just ask Paulette Hacker, who hasn’t been the same since her Awake lipo.  Her “bargain” surgery ended up costing $6,000 worth of chiropractors and hyperbaric oxygen treatments to ease her pain.  And she estimates she’ll spend thousands more to correct the aesthetic damage—because whenever she looks in the mirror, she’s reminded of her Awake mistake.

She’s been left with a lumpy back, a misshapen belly, uneven hips, a neck striated with scar tissue, an asymmetrical jawline and a conga line of polka-dot scars down her sides.  “I thought I was an educated consumer, an intelligent person,” Hacker says.  “I wish I had known: If they’re not properly trained and certified as a plastic surgeon, they have no business cutting through your skin.  If something seems too good to be true, then it is.”

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May 14, 2010

Silicone Implants Now as Popular as Saline

In June 2009, I blogged about my surprise that the vast majority of Board Certified Plastic Surgeons still prefer saline to silicone breast implants....

http://www.pickartplasticsurgeryblog.com/2009/06/silicone-breast-implants-still-not-as-popular-as-saline.html

I am a big fan of silicone implants because...

  • the newest generation of silicone implants have a safety profile equivalent to saline
  • silicone implants definitely feel more natural
  • silicone implants exhibit less rippling
  • silicone implants usually look more natural
  • silicone implants will probably be more durable

It looks like my colleagues are starting to agree.  According to statistics just released by the American Society of Plastic Surgeons, rates of use of saline and silicone implants are roughly equivalent.

  • Saline Implants in 2009 - 139,221 pairs
  • Silicone Implants in 2009 - 137,915 pairs

However, if you compare the numbers from 2009 to the 2008 data, the numbers are even more compelling.  In this tough economy, obviously there are fewer elective surgeries; the total number of cosmetic surgeries is down in 2009 relative to 2008.  However, interest in silicone continues to rise, while saline use declines.

  • Total number of breast augmentations in...
  • 2008 - 294,284
  • 2009 - 277,136
  • Saline Implants
  • 2008 - 167,125
  • 2009 - 139,221
  • Silicone Implants
  • 2008 - 127,159
  • 2009 - 137,915

I use 10 silicone implants for every 1 saline implant.  I don't mean to disparage saline implants; they remain very good products.  They still have their niche because....

  • saline implants are cheaper
  • the incisions for saline implant placement are smaller
  • the volume of saline implants can be very precisely adjusted

However, silicone is still going to be superior for most women, and I'm glad that my opinions are increasingly shared by other Board Certified Plastic Surgeons.

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May 11, 2010

Few Breast Cancer Victims Opt for Reconstruction

Over the past few decades, plastic surgeons have documented that breast reconstruction improves the emotional well-being of breast cancer victims.  Creating an attractive breast mound after a mastectomy is not only possible, but is beneficial.  Some studies have even demonstrated that the decrease in depression that results from being "made whole" can minimize anti-depressant usage and maximize compliance with adjuvant cancer treatments, such as chemotherapy.  The net effect is increased longevity; breast reconstruction can help breast cancer victims live longer.

Recognizing the value of breast reconstruction, the State of California passed legislation in 1996 mandating insurance coverage for reconstructive surgery.  The federal government followed in 1998.

However, a number of recent analyses suggest that only about 20% of mastectomy patients opt for breast reconstruction.

Researchers from the City of Hope Medical Center, in Duarte, California, recently reported the problem is especially acute in...

  • women older than 40
  • certain ethnic groups (especially African Americans)
  • public insurance (especially MediCal or Medicaid)
  • smaller hospitals

Obviously, the results indicate that it is very important to get information out to patients about reconstruction options.  Breast reconstruction is a right!

I would suggest that most breast cancer victims at least consult with a plastic surgeon before cancer surgery.  They need to know that breast reconstruction does not delay cancer treatment, does not minimize the effectiveness of chemotherapy, and does not indicate that they are "vain."  I always want women to really think about their choices.

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January 15, 2010

Tissue Glue Rather Than Drains (?!)

There is an old surgical adage:

If a surgeon thinks that the patient might benefit from a drain, he should put it in.  A surgeon never regrets placing a drain.

Patients, however, hate drains.  They are a post-operative nuisance.  Most patients grudgingly accept drains because they minimize fluid collections (called seromata) and infections.

Since drains are so uncomfortable, there have been a number of products and techniques developed to obviate the need for drains....

  • Quilting sutures beneath tissue flaps to minimize "dead space"
  • Tissue glues

Biological tissues glues are particularly exciting because they are quick, effective, and precise.  Unfortunately, there have been no specific research studies which have rigorously documented the safety and efficacy of biological glues for plastic surgery.  A study published in Plastic and Reconstructive Surgery in 2008 proved the success of tissue glues in a canine abdominoplasty ("tummy tuck") model; however, dog and human tissues do respond differently, and the results of an animal model can not necessarily be generalized to human beings.

To investigate human plastic surgery patients' response to biological glues, Cohera Medical, Inc., has just enrolled its first few patients in a study of its TissuGlu.  The clinical investigation is a prospective, open-label, randomized study to investigate the safety of TissuGlu, its effect on wound drainage, and its relationship to complications.  The study will compare 40 abdominoplasty patients in Bonn, Frankfurt, and Freiburg, Germany, who will undergo...

standard wound closure techniques versus

standard wound closure techniques plus the application of TissuGlu

Currently, patients who undergo abdominoplasties require the insertion of one or more drains to remove fluids that accumulate under the skin at the surgical site.  (The old surgical adage remains true in tummy tucks!)  However, TissuGlu will hopefully adhere the flaps created during the procedure to reduce fluid accumulation, and, ultimately, the duration of use of surgical drains.  With the use of TissuGlu, patients may experience a reduction in fluid accumulation, a more comfortable recovery, and a quicker return to normal activity.

If the European trial goes favorably, Cohera will apply for a larger U.S.-based trial later this year.  Let's say our prayers that TissuGlu works!...

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December 23, 2009

Breast Implants: Consideration #9: Complications

Are you willing to accept potential complications

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poor scarring, bleeding, infection, malposition, asymmetry, capsular contracture, finite life span of implants, wrong size

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December 20, 2009

Breast Implants: Consideration #8: Adjunctive Procedures? Lift Up? Lipo?

Adjunctive procedures

lipo of the anterior axilla or armpits or water wings

lift up

change shape, such as for constricted breasts

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