Cosmetic Stem Cell Side Effects, Health Risks, & Govt Safety Warnings

Cosmetic stem cell treatments: popular but untested, senior U.S. surgeons warn. Stem cell facelifts, stem cell breast augmentation, anyone? Why not? After all, it was only last December that American actress and sex symbol Suzanne Somers touted a stem-cell breast reconstruction surgery she had recently undergone to reconstruct a breast she had lost to cancer [see Stem Cell Breast Reconstruction].

The stem-cell breast reconstruction procedure, she enthused, had the potential to “revolutionize breast reconstruction.” In the same breath, she also admitted that she had had a stem cell cosmetic procedure done on her face by the same doctor who had conducted her breast surgery.

Suzanne’s doctor, Dr. Aronowitz, is a plastic surgeon, a diplomate of both major cosmetic surgery groups in the United States and founder of University Stem Cell Center.

The new procedure, called cell-assisted lipotransfer, uses stem cells derived from the fat cells of a person combined with liposuction techniques to reduce the chance that the postoperative breast would shrink or atrophy.

And all over the world — in New York, Florida, California, Paris, Tokyo, London, Shanghai, Melbourne, Rio de Janeiro and even in unlikely places like the Dominical Republic and Ukraine — thousands of clinics are offering so-called stem cell facelifts and breast augmentation procedures that are “proven safe and effective.”

But the situation’s gotten so out of hand; enough for senior cosmetic surgeons in the U.S. to speak out against these procedures that they say are popular — but untested.

The senior cosmetic surgeons belonging to the two major professional groups in the U.S. recently wrote a strong joint statement calling for more research into stem cell facelift and stem cell breast augmentation.

“There’s little evidence to support the safety and effectiveness of procedures, equipment and treatments that have been advertised using adult stem cells for aesthetic reconstruction, including plastic surgery and facial rejuvenation,” the surgeons say in a joint media statement released on Feb. 22.

The statement represents surgeons from both the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS).

ASAPS chief, Dr. Felmont F. Eaves III, and ASPS president, Dr. Phillip C. Haeck, collaborated on the statement, as well as Dr. Rod J. Rohrich, chairman of University of Texas Southwestern Medical Center’s Department of Plastic Surgery and editor-in-chief of the journal, Plastic and Reconstructive Surgery. Dr. Rohrich was also a former president of the APS.

In their statement, the senior surgeons warn that “there’s a lack of consistency in the way stem cell facelift procedures are performed.”

“Many procedures are being advertised by physicians who are not board-certified for this type of treatment,” the surgeons warn, adding that, “Devices being sold for aesthetic stem cell treatments have not been approved for human use in the U.S.”

While doctors or others who perform so-called stem cell facelifts and breast augmentation make many claims, “much more research needs to be conducted before any definitive statements can be made,” the surgeons say in their report.

“(Until then,) stem cell based procedures should be performed in compliance with Food and Drug Administration regulatory guidelines,” the American surgeons say.

“Further direct, approved clinical research is needed to validate those claims,” writes Dr. Rohrich.

The American surgeons also urged their peers to continue reporting clinical results and experimental research to peer-reviewed plastic surgery journals. This, they said, should be done both to both promote good science and to foster safety and best practices for stem cell use in aesthetic procedures.

Warning from British surgeons
Months earlier, senior plastic surgeons in the United Kingdom also issued a similar warning over a breast enlargement procedures being offered by British private clinics.

The procedure, which involves grafting fat harvested from the patient by liposuction and using it to build up the breast, was hijacked by private commercial interests from ongoing clinical studies, the BBC reports.

Last September, the British Association of Aesthetic Plastic Surgeons (BAAPS) warned that “stem-cell breast augmentations” are unproven and shouldn’t be offered commercially. They made their warning during their annual conference.

In ongoing lab experiments, the new technology — similar to the one used on and touted by actress Somers for her breast implant — was being tested.

Legitimate trials sponsored by the National Health Service are now under way in centers in London, Glasgow, Swansea, Norwich and North Tyneside.

But before clinical trials were completed, the same “cell-enriched fat grafting” technology was adopted — to say it kindly — by several cosmetic clinics around the world to reconstruct breasts following cancer surgery.

And the British senior surgeons believe more clinical testing is needed before the procedure can be used safely on healthy women.

“To think that this unproven research is hijacked and used in the commercial sector is really an appalling thought,” former BAAPS president and consultant plastic surgeon Adam Searle tells the BBC. “Not least when it’s being utilized by inadequately trained practitioners.”

According to the BBC, three private clinics in the U.K. that have advertised stem-cell breast augmentations for some time have done these on at least 200 patients in 2011 alone.

Cancer concern
The BAAPS warning came on the same week a new clinical data on stem cell-enriched fat grafting was presented to a conference of the U.K.’s Oncoplastic Reconstructive Breast Surgery group.

The year-long trial involved around 70 breast cancer survivors in seven centers in four countries. It was sponsored by U.S. company Cytori Therapeutics, the makers of a machine that can enrich the fat.

Eva Weiler-Mithoff, a consultant surgeon at Glasgow’s Canniesburn Plastic Surgery Unit who presented the trial details to the conference told BBC that the trial showed stem cell-enriched fat grafting appeared to be effective in filling in defects in the breast and in improving its appearance and feel. There weren’t serious side-effects reported and so far, no recurrence of breast cancer, she said. But the data hasn’t been peer reviewed.

“Traditional fat-grafting (in breast reconstructive surgery) does not work terribly well because there’s not enough circulation to support the survival of the fat graft,” she explains.

“We know if we augment the fat graft with the naturally occurring regenerative cells in fat tissues we can improve the circulation around the fat graft and the survival of the fat graft,” she adds.

But the surgeon also warns that longer-term results were needed — at least five to 10 years of data — before stem cell-enriched fat grafting could be deemed safe for use in cosmetic surgery.

“We still don’t have enough long-term outcome data to say it’s safe in the sense that it doesn’t encourage the cancer to come back or new breast cancer to develop,” she said.

“Because breast cancer is such a common disease we have to make sure whatever treatment we offer for breast augmentation is safe in the long-term.”

Previously, Japanese researchers found that cosmetic stem-cell breast augmentation was safe and effective in 40 Japanese women who had undergone it. But the researchers also called for additional study.

Breast augmentation is a booming market. In 2009, American women spent over US$964 million for “boob jobs,” edging out nose jobs as the most commonly performed plastic surgery in the U.S.

But aside from media-hyped views of beauty, breast surgery is also being driven by necessity. In the United States, 200,000 women are diagnosed each year with this cancer – and the incidence has risen from 105 per 100,000 women in 1975 to 125 per 100,000 today.

Survival rates have increased, too: 75 percent of women diagnosed in 1975 lived at least five more years. Today, 90 percent of women who contract breast cancer will survive.

This means more women will live more years after a lumpectomy or mastectomy – bogged down by pain, disfigurement and the psychological distress that comes with having to have both breasts, one or a part of their breast removed.

Some women opt for reconstructive surgery with silicone or saline-filled implants, but these surgeries can come with chronic pain and many side effects: discomfort in the breast area, pain from hernias, weakness from the donor site of the body, including muscles in the back or the abdomen.

Seldom do any of the conventional reconstruction surgeries restore the breast to its original sensation, mobility, comfort and appearance.

FDA warning
In the recent warning, U.S. surgeon Dr. Rohrich said many of the advertisements claiming stem cells can aid in restoring facial and body youthfulness come from outside the U.S.

And indeed, stem cell medical tourism is a thriving illicit trade – for both cosmetic procedures, as well as for treatment of debilitating and fatal diseases that have no cure.

Last year, the U.S. Food and Drug Administration warned American consumers about stem cell procedures both within and outside the U.S.

For patients seeking stem cell therapies in other countries, the FDA advises: learn all you can about that country’s regulations covering those products.

Be wary of undergoing treatment with a stem cell-based product in a country that, unlike the U.S., may not require clinical studies designed to demonstrate that the product is safe and effective, the FDA said in a warning still found on its website.

Pointing out that it does not regulate stem cell treatments used solely in countries outside the U.S, the agency also said it typically had little information about these treatments, the cell products and the foreign establishments that offer these treatments.

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