Irvine, Calif. — Botox maker Allergan, based here, is preparing to launch a print and television advertising campaign later this year aimed at dispelling what an Allergan spokeswoman called “myths” about Botox treatments, according to a recent Reuters report.
Carrying the tag line “Freedom of Expression,” Reuters quotes the spokeswoman as saying that the firm, “want(s) to clearly communicate that while Botox can help women enhance facial appearance, it does not freeze the face and it will enable them to have full facial expressions.”
Reuters reports that some media experts contend Allergan may be foolhardy in launching a campaign that plays off criticism of Botox, especially given growing concerns over the advertising of medical products that some say mislead the public. Some consumer groups and lawmakers are urging limits and even a ban on drug and medical-device ads.
Reuters reports that Allergan plans to submit its Botox advertisements to the Food and Drug Administration for review, a voluntary move.
Allergan also sells silicone breast implants, which the FDA re-approved in November after a 14-year ban due to safety concerns, and according to Reuters is planning a print campaign for the implants as well.
Ann Arbor, Mich. — A recently released study says that more than 40 percent of surgeons do not refer most of their breast-cancer patients to a plastic surgeon prior to the initial surgery, when the woman is choosing her treatment course.
The study’s researchers, from the University of Michigan Comprehensive Cancer Center, say their finding may help explain the low number of women who seek breast reconstruction following a mastectomy.
The study appeared March 26 in the online edition of the journal Cancer.
The researchers surveyed 365 surgeons, asking them how often they referred patients considering a mastectomy to a plastic surgeon before performing the mastectomy. Forty-four percent of the surgeons referred less than a quarter of their patients to a plastic surgeon prior to the mastectomy. Only 24 percent of the surgeons said they referred three-quarters or more of their patients for reconstruction.
The researchers write, “Women may be more inclined to choose mastectomy with a good understanding of the reconstructive options. We need to help patients through this difficult decision-making process up front, through patient decision aids that include information about reconstruction and multidisciplinary approaches to care, where all surgical options are fully explained.”
The study says the surgeons attributed low rates of reconstruction to patients not wanting the procedure: 57 percent of surgeons said it was not important to patients, 64 percent thought patients were not interested and 39 percent thought patients were concerned that reconstruction takes too long. In addition, nearly half of the surgeons felt patients were concerned about the cost of reconstruction — this despite a 1998 federal law mandating insurance coverage for reconstructive breast surgery.
Arlington Heights, Ill. — Results of a recently released study suggest that liposuction breast reduction may offer African-American women a scarless alternative to traditional breast-reduction procedures.
According to the study, which appeared in the February issue of Plastic and Reconstructive Surgery®, the official medical journal of the Arlington Heights-based American Society of Plastic Surgeons, some African-American women choose not to undergo breast-reduction surgery due to their darker skin being prone to adverse scarring.
The study examined 17 African-American women whose goal was to relieve physical symptoms associated with overly large breasts. All 17 women had liposuction breast reduction. They were studied up to six months after the procedure and all experienced alleviation or significant relief in neck, back and shoulder pain and postural imbalances. Participant interviews found that they thought their quality of life improved significantly, along with their self-esteem, overall health and well-being. No complications and no adverse scarring were reported.
The study noted that one drawback of liposuction breast reduction is that, unlike traditional breast reduction, it does not significantly lift sagging breasts. The study also noted that in most cases, patients’ breasts cannot be reduced as much as through traditional breast-reduction surgery.
Panorama City, Calif. — Woodridge Labs Inc., based here, has recalled all lots of its DermaFreeze365™ Instant Line Relaxing Formula and DermaFreeze365™ Neck & Chest products. The voluntary recall was a result of certain lots testing positive for the pseudomonas aeruginosa bacteria and is being made in cooperation with the Food and Drug Administration, the company said in a March 23 prepared statement.
According to the statement, pseudomonas aeruginosa can cause serious infection of the urinary tract, soft tissue, bones and joints, gastreointestinal tract, respiratory system and other systemic infections, as well as dermatitis and bacteremia—particularly in severe-burn patients and patients with cancer or AIDS who are immunosuppressed. Because the DermaFreeze365™ Instant Line Relaxing Formula may be applied in the area of the eye, there is a possibility that inadvertent introduction of the tainted product into the eye could result in serious eye infections and possibly blindness.
No illnesses have been reported to date in connection with this problem, says the company.
At press time, Woodridge Labs said it was working with the products’ third-party manufacturer to identify the source of the contamination so that new lots will be safe.
Gainesville, Fla. — Women who undergo breast enlargement procedures often experience a boost in self-esteem and feelings about their sexuality, according to a Science Daily report on a study conducted by a University of Florida nurse researcher.
The report says the study suggests that while plastic surgery should not be seen as a panacea for feelings of low self-worth or sexual attractiveness, it is important for health-care practitioners to understand the psychological benefits of such procedures.
The study’s findings appeared in a recent issue of Plastic Surgical Nursing.
The Science Daily report quotes the study’s author, Cynthia Figueroa-Haas, a clinical assistant professor at the University of Florida College of Nursing, as saying, “Many individuals, including health-care providers, have preconceived negative ideas about those who elect to have plastic surgery, without fully understanding the benefits that may occur from these procedures. This study provides the impetus for future studies related to self-esteem, human sexuality and cosmetic surgery.”
Figueroa-Haas studied 84 women between the ages of 21 and 57 years old, assessing their perceptions of self-esteem and sexuality before and after they underwent breast augmentation. Figueroa-Haas employed the Rosenberg Self-Esteem Scale and the Female Sexual Function Index in assessing patients’ responses.
The study found that the participants’ average self-esteem score increased from 20.7 to 24.9 on the 30-point Rosenberg scale, and that their average female sexual-function score increased from 27.2 to 31.4 on the 36-point FSF index. The study notes that a small number of participants showed no change in their levels of self-esteem or sexuality after surgery.
In addition, the study concludes that further research should be conducted to assess significant psychosocial issues that may arise after plastic surgery.
Detroit — The auto industry isn’t the only one experiencing a significant downturn in the Motor City.
According to a recent Detroit Free Press article, plastic surgeons in the area are seeing a huge worst downturn in cosmetic procedures — while numbers of procedures virtually everywhere else in the country are soaring.
The Free Press reports that with layoffs, slowed home sales and dwindling profit-sharing income, local demand for cosmetic procedures has plummeted, especially for breast augmentation and tummy tucks.
The article quotes area plastic surgeon Michael Gellis, M.D., as saying, “If you don’t have the money, you don’t spend the money on [cosmetic procedures]. It’s been a two-year downhill run.”
Dr. Gellis says his business has declined 40 percent — a similar downturn experienced by about a dozen other plastic surgeons interviewed for the Free Press story.
Dr. Mune Gowda, chief of plastic surgery at St. John/Providence Hospital & Medical Center in Southfield, Mich., is quoted in the article as saying that requests for breast enhancement are down by 50 percent, from the 100 he performed two years ago to the 50 he did last year.
Columbia, S.C. — In a change of policy, BlueCross BlueShield of South Carolina and BlueChoice HealthPlan of South Carolina are working with United Networks of America (UNA) to expand the availability of cosmetic surgery as part of discount and value-added programs for members, reports Business Wire.
Previously, discounted cosmetic-surgery services were limited to providers in South Carolina. BCBS and BCHP South Carolina members now can access cosmetic-surgery providers across the country. By presenting their insurance ID card when they visit a participating cosmetic surgery provider even outside South Carolina, members will receive discounts of at least 20 percent less than the non-discounted charges from network providers.
Discounted surgical procedures include breast augmentation, chin augmentation, eyelid procedures, face lifts, liposuction, ear pinning and nose surgery, as well as non-surgical procedures such as laser resurfacing, soft tissue fillers, cosmetic injections, chemical peels and dermabrasion.
The program will be offered through UNA’s American Cosmetic Surgery Network division.
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 Dr. Narurkar |
Vic Narurkar, M.D., tells Cosmetic Surgery Times that based on his observation, "We do think it's a growing problem. To what extent, it's hard to quantify" how many physicians or nonphysicians are using unapproved or fake products.
But in his practice, "We're seeing at least two adverse events a month" — typically ineffective neurotoxins and fast-fading faux fillers — in patients treated elsewhere, explains Dr. Narurkar, a San Francisco-based board-certified cosmetic surgeon in private practice who is assistant clinical professor of dermatology at U.C. Davis Medical Center and immediate past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery. In such cases, he says, "We don't know if they're diluting the neurotoxin or what material they're using." Simultaneously, he says there's a "huge problem" with illegally compounded 5-aminolevulinic acid (5-ALA) preparations that mimic Levulan (Dusa Pharmaceuticals; see related story, page 8). Likewise, Dr. Narurkar states, "A company in California claims to sell refurbished Fraxel (Reliant Technologies) tips. Nobody knows" how they do it or whether the process is safe.
It is clear, however, who typically uses unapproved items, sources say. "Ninety-nine percent of the people who use unauthorized drugs and devices are nonphysicians" such as medical spa aestheticians in malls and other locations, states Ranella J. Hirsch, M.D., a Boston-based dermatologist in private practice and chair of the American Society for Dermatologic Surgery (ASDS) scope of practice committee. Additionally, she emphasizes that improper use of authorized products can be as harmful as impostors."We're not just dealing with dermatologists and plastic surgeons. There's a whole cadre of noncore specialists, medical spas and others who I believe are more likely" than dermatologists and cosmetic surgeons to skirt the Food and Drug Administration (FDA), says Dr. Narurkar. Furthermore, as cosmetic treatments gain popularity, "The more pressure there may be to compete monetarily," says Joseph Niamtu, D.M.D., a Richmond, Va.-based cosmetic facial surgeon who serves on the Cosmetic Surgery Foundation's Board of Directors. "But if an OB/GYN can do a C-section, they can certainly inject a little Botox in the forehead." Also, he says it's hypocritical to complain about noncore specialists performing cosmetic treatments when the nurse in many cosmetic surgeons' practices perform the same procedures.
SCARED STRAIGHT Dr. Niamtu says that although unapproved cosmetic treatments represent a relatively small problem, it could be bigger. Before the recent case surfaced involving an unlicensed Florida osteopath who injected himself and three friends with an unlicensed research-grade botulinum toxin, explains Dr. Niamtu, "It was significantly escalating. The incident probably scared a lot of people straight."
 Dr. Hirsch |
