Injectable fillers, including temporary hyaluronic acid, collagen solutions and permanent silicone, promise a quick, youthful appearance by minimizing sagging areas, sharper lines and fat. A doctor or technician adds these solutions between the eyes, to the forehead, to the nasolabial folds, for marionette lines, to plump lips and to fill in acne scars. As a result of its swift application and results, the American Society of Plastic Surgeons declared them the fastest-growing minimally invasive procedure in 2015.

Yet, while the body eventually absorbs hyaluronic acid and collagen, requiring another set of injections, silicone permanently stays in the body. For this reason, the FDA released a safety communication letter in November 2017. The notice, geared toward both the public and health care providers, warns that the FDA never approved injectable silicone for body augmentation. The warning further specifies that patients given injectable silicone have gone onto experience a range of adverse health effects:

  • Infections
  • Long-term pain
  • Scarring, leading to permanent disfigurement
  • Embolism
  • Death

The FDA also goes onto describe the practice of illegally marketing these injections as “FDA approved.” While the FDA has approved silicone injections for a small number of procedures, the organization does not endorse them for breast and buttocks enhancements and for contouring other parts of the body. Furthermore, the FDA indicates that practices advertising these services may not even be using silicone oil. Instead, an unsuspecting consumer may get injected with industrial-grade silicone.

Background

As the only FDA-approved injectable silicone, silicone oil is commonly found in lubricants and caulk. A liquid polymer version of siloxane, it has been approved for intraocular ophthalmic use and is a different solution from the silicone used for breast implants. In spite of this, doctors have used it off-label for body contouring and other cosmetic enhancements, claiming it’s less expensive than other fillers, easier to work with, permanent and allegedly has few side effects.

Use of silicone for such purposes dates back to the 1950s, when a New York City dermatologist introduced it as a wrinkle filler. Although unapproved use went on for years, the FDA ordered medical professionals to halt this practice in 1992. Five years later, however, the organization approved a version of liquid silicone called Silikon 1000, designed for correcting detached retinas. Since this point, doctors decided to pick it up again for off-label cosmetic procedures.

While patients initially feel satisfied with the results, silicone starts to spread and migrate through the body. Effects may show up not long after the procedure – or could emerge for the first time decades down the road. At this point:

  • Silicone injected into the body or buttocks may start traveling through the body and may start to block blood vessels in the heart, lungs or brain. Long term, this occurrence may lead to permanent tissue damage, stroke or death.
  • Surgery comes with several risks. Doctors can’t completely remove silicone and, as a result, it continues to travel throughout the body, posing the same risks. Patients frequently require multiple procedures.
  • The silicone eventually becomes hard and thick, leading to prominent small to large lumps under the skin. Surgery to remove these protrusions, on the other hand, becomes extremely invasive. Doctors often must excise muscle and tissue and a patient is left with deep, disfiguring scarring after.
  • The body may have a negative reaction to the silicone, leading to long-term pain, infection and subsequent scarring.

Since releasing these findings, the FDA has recommended:

  • Avoiding all injectable fillers offered as breast and buttocks enhancements or to fill spaces in between muscles.
  • Never getting injectable fillers from an unlicensed healthcare professional or in a non-medical location.
  • Never purchasing dermal fillers over the internet.
  • Avoiding silicone injections for large-scale body contouring or enhancements.

Were you given silicone injections without being informed of all short- and long-term risks? Were you told you were receiving a solution like Restylane or Juvederm, only to find out later that a doctor injected you with silicone? Depending on the context, you may have a product liability or medical malpractice lawsuit. For assistance or to begin pursuing a case, bring your claim to Trantolo & Trantolo’s lawyers today.