Monday, June 27, 2011


DANA POINT, CALIF. – Practice skepticism when it comes to the efficacy of noninvasive fat removal devices, advised Dr. Matthew A. Avram.

"Fat removal has a long history of 'snake oil' salesmanship," Dr. Avram said at the Summit in Aesthetic Medicine, which was sponsored by Skin Disease Education Foundation (SDEF). "You can count on this to continue, because many of these devices do little, if anything. It is important to critically assess these technologies in this emerging field."

Focused Ultrasound
Dr. Avram, faculty director for procedural dermatology training at Harvard Medical School and director of the dermatology laser and cosmetic center at Massachusetts General Hospital, both in Boston, discussed the evidence surrounding devices for noninvasive fat reduction.
One non–Food and Drug Administration–cleared modality being studied is focused ultrasound, which delivers mechanical, nonthermal energy to the thigh, abdomen, and flanks. A study of 30 patients who were treated once a month for 3 months demonstrated a circumference reduction of 2-4 cm in the treated sites (Lasers Surg. Med. 2007;39:315-23). Liver function tests, a lipid panel, and liver ultrasound showed no adverse systemic effects from the procedure.
However, Dr. Avram noted that the study is limited because there was no untreated control group and that circumference "is an inherently imprecise measure of improvement that can be manipulated." MRI would prove objective improvement, he said, but it was not performed in this trial.
In a subsequent study from Hong Kong, 53 patients underwent treatment once a month for 3 months for body contouring (Lasers Surg. Med. 2009; 41:751-9). No significant changes were observed in circumference and caliper measurements, and patients rated their satisfaction as poor.

High-Intensity Focused Ultrasound
High-intensity focused ultrasound, which is also not FDA cleared, involves the rapid heating of adipocytes that are purported to produce coagulative necrosis and cell death in adipose tissue. A retrospective chart review of the modality that was used in 85 patients who underwent one treatment session showed a mean 4.6 cm decrease in waist circumference after 3 months (Aesth. Plast. Surg. 2010;34:577-82). Adverse events that lasted 4-12 weeks occurred in 12% of subjects and included prolonged tenderness, ecchymosis, nodules, and edema, as well as procedural pain in one patient, which required discontinuation of the procedure.
Dr. Avram called high-intensity focused ultrasound a promising technology, "but it's difficult to assess its efficacy. Further study of this technology is needed."

Monopolar Radiofrequency
Monopolar radiofrequency, conventionally used for tissue tightening of the face, has produced lipoatrophy with aggressive settings as a complication. "Perhaps this can be harnessed to effectively treat fat," he said, noting that clinical studies are currently underway.

Low-Level Light Therapy
Low-level light therapy, an FDA-cleared modality for fat removal, uses a multiple head, low-level diode laser at an energy level of 635 nm, which is "roughly equivalent to a laser pointer," Dr. Avram said. In one randomized trial, 59 patients received three treatments of the technology or sham treatment per week for 2 weeks (Lasers Surg. Med. 2009;41:799-809). At 2 weeks, mean circumference reductions in the treatment group were 0.98 inches at the waist, 1.05 inches at the hip, and 0.85 inches at the right thigh and 0.65 inches at the left thigh. Circumference increased in the 2 weeks following treatment.
Dr. Avram said the study was poorly designed because there was no untreated control group, the duration of treatment was only 2 weeks, and there was no ultrasound or other noninvasive evidence of decreased fat layer. "Treat with extreme skepticism," he advised.

Perhaps the most promising technology is cryolipolysis, he said, which is FDA cleared for noninvasive fat removal. Cryolipolysis involves the noninvasive cooling of fat to selectively cause cell death without damage to surrounding tissue.
The mechanism of action of cryolipolysis is believed to involve selective crystallization of lipids in fat cells at temperatures near freezing. "Apoptotic fat cell death is followed by slow dissolution of the fat cell and a gradual release of lipids," Dr. Avram explained. "The inflammatory process results in fat layer reduction over 2-4 months."
When human studies of the technology were first conducted in 2008, enrollment was restricted to 32 patients whose "love handles" were treated at a cooling intensity factor (CIF) of 33 for 60 minutes, and progressed to higher rates of energy extractions for 45 minutes per application site. One side was treated; the untreated contralateral side served as the control.
Efficacy was evaluated at 4 months post treatment via visual assessment as a primary end point, as well as ultrasound and histology. The ultrasound results demonstrated an average 23% decrease in fat layer thickness.
"In this initial group of 32 love handle patients treated once, discernible changes were seen on the treated side vs. baseline of the treated side, and compared to the untreated contralateral control," Dr. Avram said of the findings presented during a poster session at the 2008 annual meeting of the American Society for Dermatologic Surgery. "This unique study design [using each patient as his or her own control], provided very powerful evidence that this was a true treatment effect rather than a change in the patient's diet or exercise pattern during the 4 months after this single procedure exposure."
Common effects after cryolipolysis include redness, which lasts minutes to a few hours; bruising, which may last for a few weeks; and temporary dulling of sensation in the treated area, which typically resolves in 1-8 weeks. No postprocedural changes in pigmentation or laboratory abnormalities have been observed, he said.
About 1 in 2,000 patients experiences severe pain beginning 3-7 days post treatment, which translates into 26 reported cases out of 60,000 treatments. "We are not sure why these occur, but these cases completely resolve with no sequelae," Dr. Avram said.
He emphasized that cryolipolysis is not a replacement for liposuction. "It is not a weight-loss device," he said. "It's best suited for local fat removal resistant to exercise in relatively fit patients."

Dr. Avram disclosed holding stock options in Zeltiq Aesthetics, which manufactures cryolipolysis equipment. 


By Christine Mai-Duc, Washington Bureau

June 22, 2011, 11:34 a.m.

WASHINGTON — Five years after allowing silicone breast implants back on the market, the Food and Drug Administration said Wednesday that further studies showed that the decision was sound.
The FDA was criticized by consumer groups in 2006 for approving the implants after a 14-year hiatus because of widespread fear that they caused a wide range of illnesses.
But research by the two manufacturers of the implants, released in a report Wednesday, indicates that they have a "reasonable assurance of safety and effectiveness" when used properly, the FDA said.
"I don't know what the critics will ultimately say," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in an interview, "but what we can say is the current data doesn't indicate that silicone-gel-filled breast implants are linked to breast cancer or connective tissue disease or infertility."
Until 2006, women seeking implants for cosmetic reasons had been limited to the less-popular saline variety, which stayed on the market.
But the report was also quick to warn consumers against the assumption that silicone implants are risk free. Patients should still get MRIs every two years to screen for "silent ruptures" of the silicone implants, which don't deflate when they break, as saline implants do.
The agency also stressed that women should not think of silicone implants as long-term devices. According to the data, as many as 1 in 5 women getting implants for strictly cosmetic reasons had to have them removed within eight to 10 years. For patients undergoing reconstructive surgery — often after mastectomies — as many as 1 in 2 were forced to have them removed within that time frame.
The FDA effectively banned them in 1992, after fears arose of a possible link between the implants and certain autoimmune diseases. Their use was restricted to mastectomy patients participating in clinical trials.
At the time, some in the medical research community criticized the ban, saying the decision was based on public opinion, not science – and that in fact little evidence existed on either side of the debate.
What followed was a rash of lawsuits by women claiming leaked silicon from burst implants had caused ailments including lupus, cancer and arthritis. Dow Corning, the biggest manufacturer of silicone implants at the time, went bankrupt after settling a $4-billion class-action suit brought by women claiming injuries.
Since then, there have been a number of major studies that show no link between the silicone implants and connective tissue disease, reproductive problems or breast cancer.
In January, however, the FDA warned of a possible link between breast implants, both silicone and saline, and a rare form of cancer, anaplastic large cell lymphoma. But the FDA says that the low number of cases identified — just 60 worldwide — means that much more research needs to be done.
The report summarizes initial findings by the devices' manufacturers, Santa Barbara-based Mentor Inc. and Irvine-based Allergan, which were required to conduct post-approval studies on more than 80,000 women over 10 years. Five years in, the evidence doesn't link silicone implants to such diseases.
This is welcome news to the more than 300,000 women who received breast implants last year, more than 60% of whom opted for silicone.
The studies, however, will continue. Mentor and Allergan will be required to continue the research until 2016.

Sunday, June 26, 2011


FDA issues white paper on silicone breast implant safety

The Food and Drug Administration (FDA) yesterday issued an updated white paper on the safety of silicone gel-filled breast implants. ASPS agrees with the FDA statement that "silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled," and it accepts the Agency's position that women who receive silicone gel-filled breast implants for reconstructive or cosmetic purposes will need to monitor the devices over their lifetime. Both the FDA and ASPS agree that breast implants are not lifetime devices.

ASPS believes that the FDA white paper is informative and will be a fruitful resource for plastic surgeons - as well as for patients considering reconstructive or cosmetic breast augmentation.
ASPS shares the FDA's view in the white paper that more than 90 percent of patients are satisfied with their outcomes from breast implantation and report an improved quality of life.
ASPS has collaborated - and will continue to collaborate - with the FDA to ensure that science forms the basis for all decision-making on breast implants, as well as all other medical devices. The Society supports post-market breast implant surveillance and ongoing data collection related to the safety and efficacy of breast implants. ASPS will continue to reiterate that patient safety is its No. 1 priority.

The FDA has provided the following links to related documents:
FDA - Breast Implants
Update on the Safety of Silicone Gel-Filled Breast Implants (2011) - Executive Summary
The FDA also has made available a Consumer Update that contains current and background information on breast implants, as well as other links to additional documents and FAQs.

ASPS has posted additional resources for members and consumers on its website at

Thursday, June 23, 2011


Dr. D. Ralph Millard, reconstructive surgeon, UM professor, specializing in cleft lips, dies at 92

While heading the University of Miami’s and Jackson Memorial Hospital’s plastic surgery divisions, he fixed thousands of cleft lips.


Dr. D. Ralph Millard Jr., the Miami plastic surgeon who developed a method of correcting cleft lips that has saved children all over the world from living with deformed faces, died Sunday at his Sunny Isles Beach home.
Born David Ralph Millard Jr., on June 4, 1919, in St. Louis, he had recently turned 92. Son Bond Millard said his father died of heart failure.
Millard chaired the plastic surgery division at what is now the University of Miami Miller School of Medicine for 28 years, at the same time serving as Jackson Memorial Hospital’s plastic surgery chief.
He was best known for developing “rotation advancement’’ surgery in the ‘50s. The method conserves tissue that doctors had routinely removed when correcting a cleft lip, producing a natural-looking mouth in much less time.
Before he developed it, surgical procedures were performed on patients into their late teens. With his method, most children are operated on by 4 or 5.
Millard also made major advances in corrective rhinoplasty— nose surgery—for people disfigured by accidents, cancer, war wounds, even cocaine abuse.
“His work is considered pure artistry," Dr. Bernard Fogel, dean emeritus of the medical school, told The Miami Herald when Millard retired in 2000, three months before the death of his wife of 45 years, Barbara Smith Millard, orginally from Tulsa, OK. “He’s a giant."
That year, Millard was nominated as one of 10 "Plastic Surgeons of the Millennium" by the members of the American Society of Plastic Surgery. At the time, Plastic Surgery News called him “the most brilliant and creative plastic surgeon we have alive.’’
According to the World Health Organization, cleft lip, with or without cleft palate, is considered a serious birth defect affecting about one in every 600 to 700 newborns, meaning that a child is born with a cleft somewhere in the world every 2 1/2 minutes.
“Eighty to 90 percent of clefts are now done with his method,’’ said Dr. S. Anthony Wolfe, Millard’s longtime medical-practice partner. “He also pioneered [post-mastectomy] breast reconstruction when it was frowned upon, and certain types of facelifts. He operated on ... the wives, daughters and mothers of many prominent plastic surgeons.’’
A prolific author, Millard documented every one of his cases with pictures and notations, son Bond said.
Towering in both physical and professional stature, he was demanding, exacting and “not warm and fuzzy,’’ Bond added. “His students were scared of him.’’
But Millard was quietly generous with needy patients, and spent decades treating Third World children for free.
“He did so much pro bono and never told anyone,’’ Bond said. “He had set up an account for his wealthy patients to put money into for the poor.’’
“He bought cases of baby food for families,’’ Wolfe added. “If he really wanted to get a patient back [for a check-up], he’d buy the family tires.’’
Even those who could afford to pay top dollar didn’t, if Millard felt they needed his help.
Miami attorney Robert Josefsberg went to Millard in 1975 with a devastating wound: a hole in his palate caused by cancer. It affected his speech so dramatically that the sound of his voice became a courtroom distraction.
Millard, who fixed it in a 10-hour operation using a procedure he invented, “saved me and saved my career,’’ Josefsberg said.
When he got the bill, for $500, Josefsberg figured it was a mistake. Millard explained: “ ‘I pay for my fine wines and cruises with fees on elective surgery. When someone absolutely needs me on something that is very difficult, I charge the minimum.’ ’’
Millard, a lawyer’s son who served stateside in the World War II Navy, got interested in clefts as a chief plastic surgeon for the Marine Corps during the Korean War, discharging with the rank of major.
“Driving through little villages, I would see in the shadows of huts children with cleft not wanting to be seen, but to see," Millard told The Herald. He explained that he was “fascinated by the children and shocked by the pain of the parents,’’ and hit on the best way to help them late one night as he stared at the photo of a child with a cleft lip.
He focused on the “cupid’s bow’’ dimple in the top lip, which surgeons routinely excised during corrective surgery. Millard realized he could create a more natural mouth by saving and relocating the tissue.
As a young doctor, he described his new approach at the First Congress of the International Society of Plastic Surgery in Stockholm.
“There was this terrible silence because they saw for the first time how to use the cupid’s bow," Millard told The Herald. Among the few to laud him was Sir Harold D. Gillies, the legendary British surgeon, and a mentor.
“Everyone else,’’ he recalled, “looked like they had taken a cold-water enema."
Dr. Walter Mullin, another of Millard’s private-practice partners, once told The Herald: “Seldom do people truly invent new things in plastic surgery, but he did. In cleft lip, he figured out nothing was missing, it was just out of position."
Millard, an Eagle Scout, graduated from the Asheville School for Boys, Asheville, N.C. He received a B.A. in English in 1941 from Yale University, where he boxed and played varsity football.
His coach: Yale law student Gerald R. Ford, the future U.S. president.
Millard graduated from Harvard Medical School in 1944 and interned in Boston before joining the Navy in 1945. A year later, Lt.jg Millard joined a residency program at Vanderbilt University Hospital in Nashville.
In 1948, he left for England, where he trained under Harold Gillies. They would later co-author the first of his nine books, The Principles and Art of Plastic Surgery. He wrote 149 peer-reviewed journal articles and 53 book chapters.
The principles, both operational and intellectual, include “seek insight into the patient’s true desires,’’ “acknowledge your limitations so as to do no harm,” and “when in doubt, don’t.’’
“His principles have so many applications to any type of surgery,’’ noted Mullin, who practices in Dadeland. “Some of them were applicable to life.’’
Among Millard’s many honors: the American Society of Plastic and Reconstructive Surgeons’ highest award “in recognition of his development of the specialty of plastic surgery and his outstanding scientific contributions to the advancement of its practice,’’ in 1988.
In 1991, the Miami Children’s Hospital International Hall of Fame honored him with a bronze bust.
Dr. Seth Thaller succeeded Millard as the medical school’s plastic surgery chief in 1995.
Because of Millard, UM “was Mount Olympus’’ for the specialty, he said.
“He was a master, an innovator, and what he did laid the groundwork for [procedures] still in effect today,’’ Thaller said. “If not for his legacy, the division wouldn’t be thriving the way it is today.’’
An avid water skier with an affinity for cowboys, Millard would sometimes “show off’’ by roping with a lasso while waterskiing, son Bond said.
“He was very into his [three] children’s sports,’’ said Bond, who played football at Miami Country Day School, then Miami Beach High. His sister, now Meleney Moore, was a state champion in the 330-yard intermediate hurdles.
Millard’s letters to the editor published in The Herald ranged from a defense of UM football Coach Butch Davis in 1995 — “He is a winner, but more important than that, he is a man of principle ... He will eventually have a winning team, but he will not take short cuts to get there’’— to a diatribe against physician advertising in 1996: “It has always been unethical for doctors to advertise, because a reputation is gained by good results, honest and dedicated service to patients, and the respect of referring physicians. … Advertisements can claim merits unearned, skills not present, and results never attained. It can almost make a hero out of a bum.’’
Millard joined the UM medical school faculty in 1956, and was named chief of the Division of Plastic Surgery in 1967, near the start of what Wolfe called Millard’s “most productive period,’’ until the early ‘80s.
“He was very demanding of his trainees,’’ said Wolfe, who was one. “It was a philosophy of life, and most people were very grateful for that kind of attention. He would push everybody to the limit, and then stop.’’
“He used to say that he doesn’t like anything between the hammer and the nail,’’ Mullin added. “If you were good, he would say it, and if you were bad, he would say it.’’
After his wife died, Millard spent three years in Houston with his children before returning to South Florida. He travelled and continued to write into old age.
His autobiography, Saving Faces: A Plastic Surgeon’s Remarkable Story, was published in 2003.
In addition to daughter Meleney and son Bond, Millard is survived by son Duke, and six grandchildren.
A viewing will be held from 6-8 p.m. Friday at Caballero Rivero Woodlawn Funeral Home, 3344 SW Eighth St. A memorial service is scheduled for 1 p.m. Saturday at Miami Shores Presbyterian Church, 9405 Park Dr., Miami Shores.
In lieu of flowers, the family welcomes donations to The Millard Society. Go to


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