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Legal Considerations in Soft Tissue Fillers


Summary and Key Points

  • The majority of fillers currently used are hyaluronic acid, Poly-L-lactic acid, or calcium hydroxyapatite-based.

  • Adverse events range between immediate, early, and late onset events.

  • An informed consent discusses the diagnosis, nature and purpose of intervention, risks and benefits, and alternatives.

  • The standard of care is outlined based on the expert witness’s personal practice, the practice of others observed in their experience, medical literature, statutes and legislative rules, and courses discussing such subjects.

  • A cause of action in negligence and a successful claim require four elements: duty, breach of duty, causation, and damage.

Introduction

Dermal fillers are considered by the US Food and Drug Administration (FDA) as implantable medical devices. Absorbable fillers are approved for nasolabial folds (NLFs), perioral lines, lips, chin, and dorsal hands. Permanent fillers are approved for acne scars and NLFs. Some fillers such as poly-l-lactic acid and calcium hydroxyapatite are approved for human immunodeficiency virus (HIV)–associated lipoatrophy.

Soft tissue fillers are second to only neuromodulators among minimally invasive cosmetic procedures, and their use has increased more than 300% since 2000. Originally, soft tissue fillers were derived from bovine collagen, which were approved by the FDA in the early 1980s. However, hypersensitivity reactions halted their widespread use for a long time. Human collagen then emerged and increased in popularity as a semipermanent filler. Hyaluronic acid (HA) has limited immunogenicity and HA fillers came to address the need for fillers by providing an extracellular matrix polysaccharide instead of a protein to fill wrinkle lines and restore volume. HA also has a more hydrating capacity and longer duration than pure collagen. Two other classes of filler materials are also frequently used. These include poly-l-lactic acid (PLLA) and calcium hydroxyapatite (CaHA).

In this chapter, we discuss the most common types of fillers, complications of fillers, and managing these complications and outline the legal aspects relating to malpractice lawsuits.

Commonly used fillers

Hyaluronic acid

HA is a temporary filler that lasts between 6 and 18 months, depending on the filler type and location of placement. HA is a glycosaminoglycan consisting of regular repeating nonsulfated disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a naturally occurring component of the extracellular matrix, with no tissue or species specificity. It is highly hydrophilic, thus can attract water and create turgor, which can withstand compressive forces and provide supportive structure. Given its universal nature and lack of species specificity, HA has low immunogenicity. Different products vary by HA concentration, length and size of each polymer, degree of cross-linking, and presence of anesthetic. The concentration and degree of cross-linking impact the rheology of filler, and thus, its suitability in different anatomic locations.

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