Divisions of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Docket #FDA-2014-D-1856 (HCT/Ps)
Dear Madams and Sirs:
I appreciate the opportunity to comment on the Draft Guidance for Human Cells, Tissues, and Cellular Tissue Based Products from Adipose Tissue. I am writing on behalf of the members of the Virginia Society of Plastic Surgeons. As the president of this Society, I have been asked to voice the members’ viewpoints regarding the clinical use of adipose and adipose derived elements in daily practice.
Many surgeons are drawn to plastic surgery because it allows for creative problem solving for the benefit of our patients. We look at a clinical problem such as radiation damage after the treatment of breast cancer or the wasting changes after steroid injections for an orthopedic problem, and find a solution that is both structural and nonstructural in its execution. With soft tissue wasting after repeated steroid injections many have resolution of their orthopedic complaints only to have compromise of the overlying skin as a result of the loss of the fat and steroid induced changes of the skin. With fat injections initially placed to replace the structural component, it was found that the skin recovered as well from the nonstructural components transferred with the fat cells. This same additive benefit was realized with fat injections used in breast reconstruction after radiation. In its simplest form, fat is harvested and re-injected elsewhere for these benefits. Research and clinical application has refined these techniques through the use of centrifugation and separation of components to improve the safety and reliability of the treatment for the patient’s benefit. These applications are not reserved for large research institutions or commercial labs. These therapeutic interventions are being done on a daily basis in community hospital operating rooms, plastic surgeon offices, as well as University and Federal hospitals. They benefit the patients and the proposed regulation of these simple procedures would prevent the average plastic surgeon from performing them.
The VaSPS is also concerned about the misconception that breast reconstruction in general, and the use of fat grafting for reconstruction in particular, is utilizing a tissue to reconstruct the breast in a manner that is not consistent with the essential function of the breast- lactation. Breast reconstruction after mastectomy is not done to restore lactation; it is done to restore the natural appearance of a woman’s body. It is done to allow her to have an integrated tissue replacement to balance the rest of her body. All autologous reconstructive techniques involve the use of structural components that are re-purposed to take the place of the breast mound which includes skin, fat, stromal, and ductal tissues. This reconstruction may be skin, fat and muscle from the abdomen, skin and fat free flaps, or only fat. These techniques may stand alone, or be utilized to refine another technique; and are employed to restore the form and appearance of the body allowing the patient to move past her cancer. I routinely utilize fat grafts in small volumes to even out the soft tissue deficits that result from mastectomy even when the primary reconstruction may have been implants or other autologous flaps. Again, these procedures are done daily by plastic surgeons in Virginia in many types of practices and for a variety of patients with individual needs and desires.
The proposed regulations on the use of adipose and components derived from adipose will place such a burden on the average plastic surgeon as to prevent them from being able to utilize the wonderful techniques that have evolved for the benefit of our patients. We ask that you carefully consider the impact this regulation would have on our patients. Consider that through innovative thought we have learned that fat provides both a structural and a nonstructural benefit, and that with minimal manipulation by well-trained plastic surgeons the unique benefits of each component can be maximized, even in the surgeon’s office and community or University hospitals. That to regulate this as if it were a commercial enterprise would only hurt the patient.
We also ask that you consider breast reconstruction from a woman’s view. As a mother of four, I fully recognize the importance of lactation both to my children and for myself. But the three to four years of nursing or preparing to nurse are small compared to the 40 years my breasts have simply been a part of me, and who I am. How important a part is different for every woman and should be respected. Fat grafting to the breast is structural and should not be regulated as this draft outlines, or you run the risk of excluding many plastic surgeons from providing solutions for their patients. FDA oversight has been a service for our patients, but over regulation will become a burden.
Thank you for the opportunity to offer these comments. The Virginia Society of Plastic Surgeons shares the FDA’s commitment to providing patients with access to safe and effective treatments. We respect and understand the delicate balance needed to protect patient safety while still allow for therapeutic alternatives and innovation. Still, we believe that the agency’s application of that framework with respect to adipose derived HCT/Ps will have serious negative consequences for providers and patients. The Virginia Society of Plastic Surgeons strongly encourages the agency to revise its draft guidance to allow us to continue to provide these services to our patients.
Victoria L. Vastine, MD, FACS
President, Virginia Society of Plastic Surgeons