Complications Following Biologic Therapeutic Injections: A Multicenter Case Series

Eliasberg, Claire D.; Nemirov, Daniel; Mandelbaum, Bert R.; Pearle, Andrew D.; Tokish, John M.; Baria, Michael R.; Millett, Peter J.; Shapiro, Shane A.; Rodeo, Scott A.

doi:10.1016/j.arthro.2021.03.065

Cited by 17 publications

(6 citation statements)

References 24 publications

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“…Infection, sterile and severe inflammatory responses, or a combination of both are a reality, and the use of PRP must be carefully considered. 10,11 The study by Zhang et al 6 has certainly helped to strengthen the current evidence and confirmed that PRP is not improving clinical outcomes but possibly reduces retear rates. Is this enough to recommend the use of PRP routinely?…”

mentioning

confidence: 86%

Editorial Commentary: Platelet-Rich Plasma Reduces Retear Rates Following Rotator Cuff Repair but Does Not Improve Clinical Outcomes

Hohmann¹

2022

Arthroscopy: The Journal of Arthroscopic & Related Surgery

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mentioning

confidence: 86%

Editorial Commentary: Platelet-Rich Plasma Reduces Retear Rates Following Rotator Cuff Repair but Does Not Improve Clinical Outcomes

Hohmann¹

2022

Arthroscopy: The Journal of Arthroscopic & Related Surgery

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“…On rare occasions, significant complications requiring surgeon intervention have been reported. 1 In addition to pain and suffering, the patient may have experienced financial losses in addition to adverse effects from not receiving appropriate medical care for their condition. Patients rarely seek recourse in these circumstances, due to costs and uncertain outcomes of litigation.…”

Section: Reporting Mechanisms For Unproven Products and Questionable ...mentioning

confidence: 99%

Marketing of Unproven and Unapproved Regenerative Medicine Therapies

Rodeo

2024

Sports Health: A Multidisciplinary Approach

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You may have received the same blast email that I have received a number of times from a company in Scottsdale, Arizona, that opens with "End of Year Blowout Sale: 3 for 1 on Exosomes or Whartons Jelly." The email further states that these products are "manufactured in an FDAregistered, cGMP compliant, ISO Certified lab," despite the fact that such birth products can be used only in a registered FDA clinical trial, since a directive from the United States (US) Food and Drug Administration (FDA) on May 31, 2021. This is a good example of the aggressive, direct-to-consumer marketing of unapproved and unproven cell therapies.As I am writing this editorial, I see this headline from MedPage Today, January 22, 2024: "FDA Warns Exosome Maker for Marketing Outside Its IND". According to this article, the manufacturer received an Investigational New Drug (IND) for a phase I/IIa clinical trial evaluating a single intravenous dose of a drug to treat COVID-19. However, the company apparently advertised their product for numerous other conditions outside of this specific IND. Furthermore, the FDA cited the company for "significant deviations" from current good manufacturing practice requirements as well as issues with sterility testing of their product.The 2 instances documented above point out some of the challenges in the rapidly growing regenerative medicine arena. The allure of regenerative medicine has led to a global industry of direct-to-consumer offerings of biologic products that, despite their promising potential, often have very little clinical data to support their use. This has been a pervasive problem in the area of regenerative medicine and is only growing. Regenerative medicine and orthobiologics can be lucrative, leading to aggressive marketing of products that have not been tested adequately for safety and/or efficacy. In this editorial I will explain some of the tactics used in these persuasive and aggressive marketing schemes. I will then briefly describe the criteria that should be considered before a product might be considered "proven", and finally I will list some mechanisms that can be used to report deceptive advertising claims and inappropriate marketing of unproven therapies.

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“…That was my personal experience over a 1-month time frame, but several articles have described complications from the injection of purportedly therapeutic agents. In a multicenter study, Eliasberg et al 2 identified 14 patients from 6 institutions as having significant complications from the therapeutic injection of orthobiologic agents. Postinjection infections comprised 50% of the complications.…”

Section: Direct-to-consumer Marketing By Physiciansmentioning

confidence: 99%

Direct-to-Consumer Marketing: The Ethics of Snake Oil Sales?

Foster¹

2023

Am J Sports Med

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Complications Following Biologic Therapeutic Injections: A Multicenter Case Series

Cited by 17 publications

References 24 publications

Editorial Commentary: Platelet-Rich Plasma Reduces Retear Rates Following Rotator Cuff Repair but Does Not Improve Clinical Outcomes

Editorial Commentary: Platelet-Rich Plasma Reduces Retear Rates Following Rotator Cuff Repair but Does Not Improve Clinical Outcomes

Marketing of Unproven and Unapproved Regenerative Medicine Therapies

Direct-to-Consumer Marketing: The Ethics of Snake Oil Sales?

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