Facial granulomas are a well-known consequence of many facial soft tissue fillers. Among these fillers are silicone, calcium hydroxyapatite, PMMA and hydrogel. The last of these is the subject of this lawsuit. For most of these substances, it is this foreign body reaction that provides the desired soft tissue effect. In other words, the body’s reaction to a foreign substance results in the deposit of inflammatory cells that secrete collagen which remains and fills in a previously depressed area. This collagen reaction plumps the overlying skin to fill in the deformity that is the reason for the treatment.
Facial granulomas are treatable by several methods. Typically, when a granuloma is identified, the first line of treatment is injection of a steroid medication to block the inflammatory response that is the initial component of granuloma formation. With the hydrogel in Dermalive, 5-FU was recommended as a method of treatment. The next method of treatment is surgical excision of the granuloma. The magnitude of this procedure is directly related to the size and location of the granuloma. The vast majority of these are small lesions managed by direct excision. The prognosis is such that with medical or surgical management, the granuloma should resolve completely. If surgery is used, there may be a small amount of residual scarring that is visible. This is a well-known risk of the use of any soft tissue filler.
Facial granulomas are self-limited in size. They do not migrate. They have no effect on a patient’s general medical health. In the face, these lesions are superficial and require treatment only from an aesthetic perspective. Regardless of their location, granulomas are a result of placement of product in the wrong plane of the skin, most often too superficially. Because of their superficial location, systemic illness from granulomas is never an issue. More severe problems would be due to physician error, not the product itself. These lesions are limited in their extent and do not exert any influence beyond their local effect. Therefore, there is no effect on patient’s nervous system function from a granuloma of the face. Should the filler be injected in the facial muscles, while too deep to cause any filling, it could create granuloma and/or scar formation that could result in alteration of the function of the associated muscle. This may cause some reduction in muscle function; removal of the granuloma is curative and restores function to normal. Rarely, patients can get systemic illness from soft tissue injections. However, these are largely due to injections of unsterile substances or erosion of the substance through the skin, creating infection. It is the infection that creates that systemic illness, not the granuloma. Given the fact that a granuloma is generally a small lesion, the presence of such a lesion would not interfere with a patient’s activities of daily living.
Facial granulomas from facial soft tissue fillers medical expert witness specialties include plastic surgery, pediatric plastic surgery, and pathology.