FDA approves Cytori's PureGraft fat grafting device

This week, the FDA approved the PureGraft device, made by Cytori Therapeutics. This device greatly simplifies the collection, processing and re-injection of fat. It could be a major "game-changer" for both cosmetic and reconstructive plastic surgery.

Until now, one of the major issues with fat grafting has been that it is a slow and tedious procedure with an unpredictable outcome: it's hard to know how much of the transferred fat will actually survive the move to the new location, even with the use of the specialized techniques developed by Dr. Sidney Coleman and others. We liposuction out the fat with specialized instruments, centrifuge it, reload the good quality fat into small syringes, then inject it slowly and carefully, just a little bit at a time, into the desired area. Then we hope and pray that the injected fat will survive in its new location. Sometimes, we watch as it melts away almost totally in several months - and that's so frustrating for both patient and surgeon!

The Cytori device should allow more predictable, less laborious fat fat grafting procedures. The PureGraft device not only purifies the fat, but increases the number of the patient's own stem cells in the material to be re-injected. This "turbo-charging" effect of the stem cells seems to lead to better outcomes, in recent research studies, with a higher rate of fat survival and less fat necrosis.

I'm very excited by this new technology. I think it's the next big thing.

New study on fat grafting to the breast

It's seems like a perfect answer - "take a little off down here, put some a little more up here". But fat grafting to the breasts has been controversial. A problem, known as fat necrosis, has been the #1 concern. Lumpy deposits of injected fat, which may feel exactly like a breast cancer, can result if the fat does not survive the transfer, and goes on to form calcified scar tissue within the breast.

Previously, back when radiologic imaging of the breast was less advanced, sorting these lumps of scar out from early breast cancers was a real problem. Surgical biopsies were sometimes needed to make the determination. Over the last decade, though, a lot of work has been done on fat grafting, reappraising its role as a reconstructive tool. Here in the U.S., Drs. Coleman and Khouri, two plastic surgeons who have been independently making major contributions to this area, deserve a lot of credit.

In this month's issue of the Aesthetic Surgery Journal is an important study looking at the safety of fat injection to the breast. This work, from Lyon, France, summarizes 880 procedures over 10 years, and mainly looks at the application of fat grafting for reconstructive applications - following mastectomy reconstruction, and for breast asymmetries and other developmental problems.

The French group in the study used Dr. Coleman's technique (low-pressure small cannula liposuction of the fat from the donor area, purifying the fat with a centrifuge, then injecting it in very small volumes into the target area). None of the more advanced techniques that have been recently reported to enhance fat grafting success were used -i.e. no addition of stem-cells, or use of the external BRAVA suction device.

Very careful breast imaging was mandatory - both pre-op and at one year post-procedure, using mammograms, ultrasound and MRI. The French radiologists "signed off" on the normal status of the exams before the patient underwent surgery. (I wonder if any lawsuit-averse U.S. radiologists would be willing to do that!) While all patients had some post-surgical changes in their post-op mammograms, the radiologists were, in general, able to sort out these changes with the use of the more advanced imaging methods and a lot of experience.

Ninety percent of the results were rated as either "good" or "very good". As expected, the surgeons found that about 40% of the injected fat melted away. Fat necrosis - formation of lumpy scar tissue - was seen in 15% of the authors first 50 cases, decreasing to about 3% after that. In some cases, a needle biopsy of the lumps in the breast was still required.

Overall, good improvements in the breast contour and degree of symmetry were reported, and the authors felt that fat grafting represented a very good technique for "touching-up" results after a complex breast reconstruction, or avoiding a more-complex reconstructive method. They also showed nice results for breast asymmetry and cases of Poland's syndrome, a developmental breast problem.

Bottom line: fat-grafting to the breast is a procedure which, while very promising, is still under development. Guidelines about timing, indications, pre-op and post-op MRI imaging, and important details regarding the best technique are still being sorted out. I can not yet recommend it for cosmetic breast enlargment at this stage, outside of a carefully controlled clinical trial.

Fat grafting to the breast

Recently, there has been a resurgence of interest in the idea of using a person's own fatty tissue to enhance the breast. It seems like the ideal combination: "take a little off there, and put a little bit more up here".

The truth is: it's still a work-in-progress. Until recently, fat grafting to the breast had been considered a bad idea. Lumpy breasts, with oil-filled cysts, could occur. And worse, the scar tissue which sometimes formed after fat injections could exactly mimic the appearance of a breast cancer on a mammogram, leading to needless anxiety and additional biopsies.

Lately though, there has been a re-appraisal of this idea, both here in the USA and abroad. A breakthrough study from Japan found that the key factor to making the fat injections work in the breast seems to be the addition of stem cells.

By "turbo-charging" the injected fat with the person's own adult stem cells (also found in fatty tissue), the combination of fat cells and stem cells worked much better, successfully surviving the move from the donor site to the new location in the breast without the problems listed earlier.

Some pretty clever machinery is used to harvest, centrifuge, and purify the stem cells from liposuctioned fat. Some far-sighted biotech companies have already submitted automated versions of this machinery for FDA approval.

The Japanese group made fairly modest changes in the patient's breast size - averaging about 200 cc, which is small compared to the typical breast implants that we use here (commonly 300 - 500 cc), but their results show that the technique is promising. The fat-grafting surgery also takes much longer than a typical breast augmentation: about 6 hours of anesthesia time, compared to about 1 hour when implants are used.

Nevertheless, it's an exciting surgical innovation that someday (I hope) will be in common use. Currently, the technique is not FDA-approved, and is still in the "experimental" stage.