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Diaz, et al. v. Cynosure, Inc., et al.,

Dr. Barry DiBernardo’s Testimony on Fat Removal Laser Leads to Deense Verdict in Product Liability Case

The Expert: Dr. Barry DiBernardo, a New Jersey-based cosmetic surgeon and a lead investigator for the laser treatment, testifies as to whether the patient was an appropriate candidate for the procedure.

By Dr. Gary F. Gansar, MD, FACS
Senior Physician Medical Director, AMFS

During a 2019 product liability trial, Dr. Barry DiBernardo, a New Jersey plastic surgeon, testifies for the defense against a claim by the plaintiff that a defect in a laser fat removal system left the patient with permanent pain and scarring. The expert in this case was a lead investigator for this new laser treatment.

DiBernardo begins by explaining that the plaintiff had a previous liposuction procedure in the area to be reoperated on and that performing the procedure under these circumstances was contraindicated according to the instrument’s manual. It was also especially unwise given that this was the surgeon’s first time using the new “Cellulaze” system. As such, the expert felt that this would breach the standard of care for plastic surgeons under the circumstances. 

The patient, the expert maintains, was not a good candidate for this newly developed fat removal system and her post-operative poor outcome was related to the physician’s inexperience and his use of the Cellulaze in an area that had been previously damaged by liposuction. His contention was that the instrument was not defective, the patient selection was.

Dibernardo goes on to explain why he believes the Cellulaze’s use was contraindicated in this patient. He explains that the fact that the patient had been previously treated with liposuction could easily complicate the attempts to contour cellulite with the new laser system by causing irregularities due to scarring and disruption of blood supply.  For instance, the previous surgery would have disrupted veins and lymphatic vessels leading to excessive swelling post operatively. 

Even more importantly, the Cellulaze system is not designed to deal with postoperative scarring that would be encountered in a patient that has had liposuction. The small laser system can disrupt the structure of normal fat cells, not those that have been previously damaged, and the patient’s normal connective tissue between the fat collections can be purposely disrupted by the Cellulaze system to smooth the small depressions of true cellulite. Using this laser to disrupt either previously damaged fat cells or scar tissue bands will lead to inconsistent results, at best. 

The expert also notes that this system is designed only to deal with the immediately subdermal fat that causes cellulite, not the deep fat that causes major contour problems. The previous liposuction will cause irregularities in the contour of the skin from scarring that may give it the appearance of cellulite, when it is not. Cellulaze has been developed just for the treatment of cellulite. If the depressions and bulges in the skin are not due to true cellulite, then the treatment with the Cellulaze product is far less likely to produce a favorable outcome. In other words, the sort of post -liposuction problems that produce large depressions and fat bulges will be inadequately treated with this small laser system and will require repeat liposuction and fat grafting.

DiBernardo stresses it was unreasonable for the surgeon to have attempted to treat such a complicated case with his first use of the Cellulaze. He was just learning how the system works, yet he chose to operate on a patient with contraindications. This more likely led to the unsatisfactory outcome rather than any defect in the Cellulaze laser system. 

The jury agreed, rendering a verdict for the defense.

About the Author Dr. Gary F. Gansar, MD, FACS

Gary Gansar, MD, is residency-trained in general surgery. He served as Chief of Surgery and Staff at Elmwood Medical Center and on the Medical Executive Committee at Touro Infirmary and Mercy Hospital in New Orleans, LA. Dr. Gansar was Board Certified in general surgery while in active practice. He joined AMFS in 2015 as a Physician Medical Director.

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