Cosmetic Surgery Clinical Trials

By Denise Mann; reviewed by Peter Fodor, MD, FACS

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What Is a Clinical Trial?

Clinical trials are research studies in which people agree to undergo new therapies (under careful supervision) to help identify the best treatments with the fewest side effects. Such trials often help change and shape the landscape of medical care.

There are several types of clinical trials, including treatment trials, prevention (risk reduction) trials, diagnostic trials and quality-of-life trials (which explore ways to improve quality of life for individuals with a chronic illness).

In cosmetic surgery, clinical trials are usually treatment-oriented. For example, many surgeons are now looking at cohesive gel breast implants, which have the positive attributes of the silicone gel implant, but do not pose the risk of gel migration. Another clinical trial is looking at the safety and effectiveness of so-called fat-melting technology, known as mesotherapy or lipodissolve. In reconstructive surgery, clinical trials may tackle the issue of delayed versus immediate breast reconstruction in women with breast cancer.

People who participate in clinical trials can play a more active role in their own health care, gain access to new treatments before they are widely available and help others by contributing to medical research. They typically will get excellent care from the doctors during the course of the study. This care also may be free.

All clinical trials have guidelines about who can participate (inclusion criteria), as well as guidelines that prevent someone from participating (exclusion criteria).

Are Clinical Trials Safe?

Clinical trials have risks. They can include unpleasant, serious or even life-threatening side effects that may be different from the side effects of currently available treatments. What's more, the treatment may or may not be effective, and the design may require more time than traditional care.

Safeguards are in place to protect participants. Every clinical trial in the United States for a new therapy or type of device must be approved by the federal Food and Drug Administration (FDA). In addition, an institutional review board (IRB) approval is also required. These safeguards help make sure the risks of the clinical trial are as low as possible and are worth any potential benefits. If you do decide a clinical trial is the route you'd like to take, informed consent (the process of learning the key facts about a clinical trial before deciding whether to participate) is required.

According to the Office for Human Research Protections, here are some questions to ask if you are considering joining a clinical trial:

  • Why is the research being done?
  • Is the trial FDA-approved?
  • Is the trial IRB-approved?
  • What will be done to me as part of the research?
  • How will I benefit from the research?
  • Could the research hurt me?
  • What will the researcher do with my information?
  • Will the research cost me anything?
  • Who pays if there is a complication?
  • How long will the study last?
  • What happens if I decide to leave the study early?
  • Who should I call if I have a question about the research?

Want to Participate in a Cosmetic Surgery Clinical Trial?

As a service to our readers, we provide access below to the clinical trials database of the U.S. National Institutes of Health and its National Library of Medicine, located at ClinicalTrials.gov. To participate in a clinical trial, please read the information and get in touch with the contact person directly. Consumer Guide to Plastic Surgery has no connection with the people and organizations who run these trials.

Below are listed the current clinical trials in cosmetic surgery.

To search for clinical trials in specific areas of cosmetic surgery, click on these links:

About the Reviewer of This Article

Peter Bela Fodor, MD, FACS, of Los Angeles, is an internationally recognized leader in the field of aesthetic plastic surgery and is highly respected by the profession as a surgeon, teacher and author. Dr. Fodor is associate clinical professor of plastic surgery at UCLA Medical Center. He lectures and performs live surgical demonstrations nationally and internationally.

After graduating from the University of Wisconsin Medical School, Dr. Peter Fodor completed his general surgery residency at New York’s Columbia University and his plastic surgery residency at St. Luke’s – Roosevelt Hospital. Dr. Fodor maintains hospital staff privileges at UCLA Medical Center, Century City Doctors Hospital and Olympia Hospital, all in Los Angeles, as well as at St. John’s Hospital in Santa Monica, Calif. He is board-certified by both the American Board of Surgery and the American Board of Plastic Surgery.




Sources:
Understanding Clinical Trials. National Institutes of Health website.
Questions to Ask Before Participating in a Research Study. Office for Human Research Protections section of U.S. Department of Health and Human Services website.