Unapproved Stem Cell Surgical Dangers

Stem cell research holds a number of promising medical treatments. Stem cell treatment is still a developing area of medicine but some potential breakthroughs have included: 

• Making new heart muscle
• Tissue regeneration
• Spinal cord injury repair
• Diabetes treatment
• Cancer treatment

However, some practitioners may be putting patients in danger by using stem cell therapy against recommendations. Untested stem cells in cosmetic surgery can result in unintended consequences, including one patient who began developing bone tissue in her eye. 

Bones Growing in Eyes After Botched Facelift 

A woman in California underwent a facelift as part of a cosmetic surgical procedure. The treatment included using stem cells from fat in the woman’s abdomen to inject into her face. Injecting fat cells into the face was intended to “rejuvenate” the skin. However, after a few months, the patient went to her doctor, complaining of pain and a clicking noise in her eye. 

Finally, the patient went to another doctor for a second opinion. The patient complained of pain in her right eye whenever she tried to open it, and hearing a clicking sound. During surgery, the doctor dug out pieces of bone from the patient’s eyelid and tissue around the eye. One possibility is that the stem cells reacted with calcium in the skin filler to develop into bone tissue. 

Using a Patient’s Own Stem Cells for Regrowth

The facelift procedure involved taking the patient’s fat cells, isolating adult stem cells, and injecting the cells back into the patient’s face, around the eyes. The cells, mesenchymal stem cells, have the ability to develop into a number of types of cells, including cartilage, bone, and fat. The sales pitch of the procedure describes how the stem cells will turn into new tissue and release chemicals to stimulate new cell growth and help aging cells heal. 

According to an article in Scientific America, the procedure was not approved for use in patients. At the time, the FDA had only approved one stem cell treatment for bone marrow stem cell treatment for people with blood cancer leukemia. Still, many stem cell treatments are provided in a gray area, where it is not illegal but still not approved. 

Cosmetic Treatments Not Subject to Medical Testing

Cosmetic treatments are not necessarily subjected to the same testing and studies as medical treatments. Cosmetics are still regulated by the FDA but do not have to be FDA approved. This may sound confusing, and in some cases, cosmetics are also considered “drugs,” subject to FDA regulation. 

Under federal law, cosmetics are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” (FD&C Act, sec. 201(i)). 

However, if a product is intended for therapeutic use, treating a disease, preventing disease, or affecting the structure or function of the body, then it is considered a drug. The difference between a cosmetic and a drug may come down to a description of what the product claims to do. 

Did Your Doctor Warn You of All the Risks?

There are always risks associated with surgical procedures, even routine surgery. In order for a patient to make an informed decision about their medical treatment, the doctor has to provide enough information about the risks and benefits. Failure to get informed consent can make the doctor liable for any injuries or losses caused by the surgery. 

If you suffered complications after cosmetic surgery, leaving scars or requiring multiple procedures, talk to experienced Philadelphia medical malpractice lawyers. The skilled medical malpractice attorneys at Gilman & Bedigian fight to get compensation for injured patients. Contact our law office online or by calling (800) 529-6162.