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REVIVE: PRP Pioneers Discuss Market Controversies

REVIVE: PRP Pioneers Discuss Market Controversies

When properly harvested and applied, platelet-rich plasma (PRP) and similar products are an extremely safe and powerful tool in the medical and aesthetic arsenal. However, this growing market for production and application devices is built on a vulnerable reputation for those seeking to make quick money at the expense of good medical practice – a potential problem for any cosmetic treatment.

This is what motivated the foundation of REVIVE TM Advanced Training Consultants Independent CME training which strives to teach aesthetic providers only the safest, most rigorously tested and most advanced state-of-the-art PRP techniques, in order to obtain the best results. for all patients.

médecine esthétique REVIVE Les pionniers du PRP discutent des controverses sur le marché 2

Editor’s note: In its special edition on regenerative aesthetics, The Aesthetic Guide, in partnership with REVIVE, met with pioneering clinicians experienced in the use of PRP to hear their views on the emerging controversies surrounding PRP and the future of regenerative aesthetics. The opinions, opinions and opinions expressed in this editorial relate only to the respondent doctor and are not representative of the entire group.
The Aesthetic Guide (TAG): What are the ideal characteristics for PRP? Is a higher concentration of platelets better?
Amelia Hausauer, MD: Consider more characteristics than focus only on platelet concentration. In the manual that I co-edited and collaborated with Derek Jones, MD (PRP and Microneedling in Aesthetic Medicine; Thieme Publishers LLC, 2019), we set out to educate doctors about the differences between the preparatory systems and the selection of the right PRP system. for a variety of applications.
We also now have the DEPA classification system (Dose Efficiency Purity Activation), useful for qualifying the meaning of the term “PRP”. It is not a single product, but a family of products based on ratios and absolute quantities. platelets, leukocytes and erythrocytes. For the skin and hair treatments that I practice in my practice, I prefer a pure PRP, free of contaminating red and white blood cells.
Gordon Sasaki, MD: A concentration too high or too low in platelets could negatively affect the result. The maximum benefit for each application is likely to be found on a bell curve. Total platelet count, not concentration, is the most accurate way to describe the dosage. With the support of a grant, we launched the first study initiated by an investigator and comparing the results obtained with a high or low platelet total. I think this will add a lot to the field, which will make it easier for patients to optimize results.
TAG: While the story of HIV cross-contamination in New Mexico spas makes the headlines, how do can doctors and patients be sure PRP treatments are safe?
Dr. Sasaki: As far as I know, the case in New Mexico involved a non-medical spa and a non-medical practitioner. It is important that patients and physicians understand that PRP treatments should be performed with a disposable, single-use, FDA class II tip. Healthcare providers are trained to handle blood products safely and can therefore perform these treatments using sterile techniques and approved methods for patient selection and disposal of blood products.
TAG: Does the PRP need more regulation?
Jeffrey Rapaport, MD: The regulations in force are sufficient. The FDA has provided guidance on how to determine if a technology is safe and effective for autologous PRP applications. This is called a 510 (k). Companies whose kits are not approved by the FDA are asking me all the time, claiming that these are Class I blood collection tubes, but they are selling illegally to doctors and should not be on the American market. .
TAG: How can a doctor be sure that the PRP product he uses is approved by the FDA?
Dr. Hausauer: If you just ask the company for the number 510 (k ) of the product, you can search for it on FDA.gov and confirm it yourself. The problem is that, in some cases, new PRP products sold at conferences or presented in magazines are not authorized by the FDA. This must be taken into account. We expect patients to do their homework; doctors must do the same. Threatening patient safety or the quality of results just to save money is in direct contradiction to the Hippocratic Oath. Note also that PRP production devices are generally authorized for orthopedic indications, so their aesthetic use is considered as non-compliant.
TAG: What are the risks for doctors who use “do it yourself” methods not approved by the FDA?
Charles Runels, MD: The safe PRP kits can cause a life-threatening fever caused by a pyrogen. In vitro diagnostic (IVD) blood collection tubes are inexpensive because they are designed for laboratory work and are not produced in a clean room manufacturing environment. There could therefore be endotoxins in the tube. It says on the package that they are not considered safe for preparing plasma to be injected into patients. The lawyers have a day in the field with a doctor who injured a patient with an in vitro diagnostic tube.
TAG: What should be done to make doctors aware of this particular problem?
Dr Runels: We ask members of our group, the Cellular Medicine Association, d ” Use legal FDA approved PRP products. If a member is inexpensive and uses IVD tubes or products not approved by the FDA, membership is revoked. The success of PRP and branding procedures depends on trained medical providers using good techniques with secure kits. When done correctly, PRP is one of the safest and most cost-effective treatments you can do.
TAG: What other risk trends should physicians and patients be aware of?
Dr. Hausauer: The availability of online videos on PRP and microneedling is disconcerting because people can get items for this type of treatment from China via Amazon. Some of these things should not be available to the general public. These are medical procedures to be performed in a clinical setting under the supervision of a highly qualified, certified and certified doctor.
M. Rapaport: I fear that China will enter the American PRP market through ” a Beijing manufacturing company offering a product for several American private label distribution companies. If it succeeds and patient outcomes decline or someone is injured, the PRP market as a whole suffers. From what I have observed, the gel migrates inside the tube without centrifugation, behaving almost like a liquid, and could eventually end up in the final injected product.
Dr. Runels: Many of these Chinese kits are not ready for prime time in this market. If you choose a separator gel-based PRP collection system, choose those with a proven history of safety and several clinical trials supporting their effectiveness and safety. If you’re trying to save money, companies can work with you.
TAG: How does a supplier find safe and effective PRP products and protocols?
Dr. Hausauer: Evidence-based medicine is at the heart of my practice in aesthetic dermatology . Know where your products are made and which techniques give the best results safely. With the controversy in space, suppliers must seek unbiased, science-based answers. This is why Dr. Rapaport and I joined the REVIVE faculty. We have seen the need for high-level CME programs to demystify PRP and to teach up-to-date and proven treatment protocols.
TAG: What about positive developments that exist? What excites the future of PRP?
Dr Sasaki: The companies are working on technologies that will improve the way we do things . We know a lot more about how to optimize results. Patient satisfaction with PPR seems higher than ever and doctors who use the latest protocols can achieve more predictable results.
Dr Rapaport: Several years ago, I started using PRP on friends and members of my family with very little advice. I had to go through the literature and come up with a treatment plan myself. Today, we have books on the injection technique and treatment intervals that I developed with the exact 22 ml PRP kit that we use in our practice. As a result, we can better manage and often exceed patient expectations.

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