Will Silicone Implants Return to the Market?
The US Food and Drug Administration (FDA) has given Inamed Corp, a manufacturer of silicone gel–filled breast implants, a conditional approval—in the form of an “approvable” letter—to return silicone implants to the market. The conditions were not revealed.
The implants have been exonerated because of concerns that they might cause serious chronic illnesses such as breast cancer and lupus.
According to the FDA, Inamed says that it will not sell a particular style of implant that has raised safety concerns.
MediCor Ltd, a manufacturer and distributor of silicone and saline-filled breast implants in more than 70 countries, plans to file for an investigational device exemption with the FDA for high-consistency silicone-filled breast implants.
“Given the recent positive developments with respect to silicone breast implants in the United States, we be-lieve the time is right for MediCor to introduce its advanced high-consistency silicone-filled implants to the US market,” says Jim J. McGhan, Medi-Cor’s CEO. “Our plan to apply for an investigational device exemption and begin clinical trials represents yet another significant milestone for MediCor as we continue to grow our business and develop products for the aesthetic, plastic, and reconstructive surgery markets.”
MediCor is currently conducting US clinical trials on prefilled saline and inflatable saline-filled breast implants. The company expects to file for premarket approval of the inflatable implant by the end of 2005 and for the prefilled implant in 2006.
Breast Reduction May Detect Early Breast-Cancer Risk
According to a study conducted by the American Society of Plastic Surgeons (ASPS), 12% of breast-reduction pa-tients may have abnormal pathologies that increase their risk of developing breast cancer. The study also found that screening mammography, when recommended, should be performed on breast-reduction patients of all ages, rather than only on those over 40.
“If we were to limit our pathologic examination of breast tissue to breast-reduction patients older than 40, we would fail to identify 20% of moderate- to high-risk pathology, which is simply not an acceptable risk,” says Kristin Stueber, MD, Springfield, Mass, ASPSmember surgeon and coauthor of the study. “Besides the potential cost savings in testing, the cost for treating a cancer patient down the road is certainly more than any savings we could produce in the short term.”
The study involved 300 patients 14 to 73 years old. Twelve percent had abnormal pathology reports that indicated premalignant lesions or lesions that put the patient at increased risk of developing breast cancer.
According to the study, examining only women over 40 could have resulted in a savings of $81,688, based on a cost of $381.72 per exam. However, by selective testing, two potential cases of breast cancer would have been missed.
Men Join the Plastic-Surgery Bandwagon
An increasing number of men are making their way to plastic surgeons’ offices to get rid of wrinkles and leg veins.
“I’m not interested in looking young, but looking younger than I am,” says Nelson Vetanze, a chiropractor who seeks quick fixes at the Cara Mia Medical Day Spa in Englewood, Colo. “My wife does it and looks good, so I figure if she can do it, so can I.”
Vetanze was among 55 men who attended “mens’ night out” at the Cara Mia Spa to learn about aesthetic procedures. By the end of the night, 90% of the men had purchased treatments or made appointments for treatments.
“One of my male patients suggested ‘mens’ night out,’ ” says Leslie Capin, MD, the spa’s medical director. “We’ve done ‘girls’ night out’ for 3 or 4 years, and it’s become so popular we are having to turn people away.”
According to the American Society of Plastic Surgeons, from 2000 to 2004 the number of nonsurgical treatments performed on men increased significantly—botulinum toxin Type A injections increased 250%, microdermabrasion increased 160%, and laser treatment for leg veins increased 164%.
Are Bones to Blame for the Aging Face?
A study has found that shrinking facial bones play a big role in facial aging and that women experience this type of bone loss at a younger age than men.
“Many people believe that only gravity creates wrinkles,” says David Kahn, MD, Brookeville, Md, the author of the study. “However, we have discovered that the loss of volume in the face and changes in the bone structure also contribute to making us look older. As we age, not only do we lose fat in our faces, but our bones actually change in contour, often making us look older than we feel.”
The study, which analyzed tomography scans of 30 women and 30 men ranging from 25 to 65 years old, found that as individuals age, their facial bones dissolve, shrink, and leave empty spaces. The study also found that because the skin loses elasticity with aging, it cannot tighten around the spaces left by facial-bone loss, resulting in drooping and wrinkles.
“By using fillers, along with other cosmetic plastic surgery techniques such as forehead lifts and soft-tissue repositioning, plastic surgeons can re-create volume loss caused by shrinking bone and lift the skin to create more refined results for patients,” says Kahn.
Ignoring BDD Patients Can be Harmful
Gregory Chernoff, MD, associate clinical professor at Indiana University School of Medicine, Indianapolis, says failing to recognize body dysmorphic disorder (BDD) syndrome in potential patients can have harmful consequences for plastic surgeons. According to Chernoff, in the past 10 years, four plastic surgeons have been murdered by their patients—and most of these patients have had some element of BDD.
“Usually, their perceived problem is much less evident to the outward eye than to them,” says Chernoff. “They may have a small mole on their cheek that they think the whole world notices, when, in fact, one sometimes must get closer than conversational distance to see it.”
According to Chernoff, BDD sufferers are easy to identify and exhibit what he calls “the relentless pursuit of perfection” by going to multiple aesthetic surgery offices, seeking multiple treatments, and openly criticizing physicians who have previously treated them. They will also play to a surgeon’s ego by saying, “I’ve heard so many good things about you. Surely you’ll be able to help me when no one else has.”
Chernoff says that according to earlier research, the common reasons BDD sufferers schedule consultations are for problems with the skin, hair, nose, and eyes.
Accufuser Receives FDA Clearance
The US Food and Drug Administration (FDA) has issued premarket notification clearance to McKinley Medical LLC for the Accufuser® postoperative pain-control pump. The Accufuser pump is a portable, nonelectric balloon infuser that delivers a continuous infusion of local anesthetic through a special catheter to the surgery site. With the press of a button, patients receive additional doses of non-narcotic medication.
“We’re now able to educate surgeons and anesthesiologists on the significant narcotic-reduction benefits of the Accufuser pump, which have been reported in recent clinical research and which confirm previous clinical experience with portable regional infusion pumps used to manage postoperative pain,” says Randy Hoffman, president of McKinley Medical.
A recent study involving 50 patients conducted at the Aesthetic Center for Plastic Surgery in Houston found that abdominoplasty patients who used an Accufuser pump to relieve their postoperative pain required 49% less narcotic pain medication, regained mobility 22% faster, and resumed normal activities 21% faster compared to a control group of patients.
Mark Your Calendars
The American Society of Plastic Surgeons and the Plastic Surgery Educational Foundation will conduct the symposium, “New Horizons in Cosmetic Surgery: Comprehensive Facial Rejuvenation,” in Indian Wells, Calif, January 27–29, 2006.
The program will address facial anatomy, musculature, and retaining ligaments. It will also provide an update on the histopathology of aging skin, classification of skin types, skin-resurfacing options, facial fillers, and implants.
A panel will focus on facelift techniques, nonablative skin rejuvenation, and hair removal. The presenters will explain favorable and less-favorable results. Faculty will discuss challenges associated with the difficult midface, neck and brow rejuvenation, and share case examples to further illustrate technique outcomes.
A session will be devoted to examining common complications that can occur following facial-rejuvenation surgery. Principles of prevention and patient safety will also be emphasized.
For more information or to register, visit www.plasticsurgery.org.
PCA Changes Its Name
Physician’s Choice of Arizona Inc, Scottsdale, Ariz, has changed its name to PCA Advanced Skin Care Systems. This name was selected to embody the company’s growing global presence and to unify brand recognition of the expanding family of treatments and products marketed by the company.
“The company has evolved significantly since we opened our doors in 1990 with a professional skin-care system that included seven products,” says Margaret Ancira, the CEO and founder of PCA. “Today, we offer 50 of the most scientifically researched and effective professional and home-care products available.”
PCA Advanced Skin Care Systems currently offers 11 topical systems that address acne, eczema, rosacea, hyperpigmentation, psoriasis, and sun damage. These systems are carried under the brand names PCA Professional Products, PCA SKIN® Clinical Care Products, and PCA® MEN.
A New Breast-Reconstruction Option
A new breast-reconstruction procedure is gaining popularity with American women. The deep inferior epigastric perforator (DIEP) flap reconstruction allows a plastic surgeon to harvest stomach tissue and fat while preserving abdominal muscle. The tissue is cut free and transplanted to the chest. The perforator vessel is then connected to an artery in the underarm area of the chest to supply blood to the tissue.
DIEP flap reconstruction procedure is performed simultaneously with a skin-sparing mastectomy that involves making an incision around the edge of the areola of the nipple and hollowing out the breast. The plastic surgeon can then refill the breast with abdominal tissue. A few months after surgery, the breast will look and feel like the patient’s original breast.
Plastic surgeons are hopeful that the DIEP flap procedure will someday replace the traditional TRAM flap procedure, giving women a breast reconstruction without limiting their activity later in life.