What Does it Mean to be Enrolled in Breast Implant Clinical Trials?

A breast implant clinical trial is a research study that allows a manufacturer to prospectively evaluate the safety and efficacy of an innovative new breast implant. “As manufacturers develop new technologies, they want to bring those devices to the U.S. market,” explains Dr. Caroline Glicksman, board certified plastic surgeon with over two decades of experience as a principal investigator in multiple breast implant clinical trials. “If a manufacturer wants to get a device onto the market, they have to begin the process by enrolling subjects in clinical trials at both university hospitals and private practice offices around the country.”

Prior to FDA approval, the only way subjects can gain access to investigational implants in the United States is to be enrolled in a clinical trial. Along those same lines, other new developments in breast implant technology must always undergo extensive studies and clinical trials prior to being sold and distributed in the United States.

Not Everyone is a Candidate for a Clinical Trial

The Food and Drug Administration (FDA) closely monitors all clinical trials in the United States. A breast implant manufacturer must set up their trial in association with a group called an IRB, which stands for Investigational Review Board, that will oversee the trial and study data as it is collected for a period of 10 years or possibly longer. The study protocol and the IRB lay out very strict guidelines for both patient inclusion and patient exclusion criteria, meaning not just anyone can participate. “Not every patient who wants to get a breast implant in a clinical trial will be a good candidate,” points out Dr. Glicksman, “some patients may not be eligible because they are too young, or have an illness that disqualifies them for enrollment in the study.”

The same strict guidelines also apply to the surgeons who serve as investigators in a clinical trial. Each office, the staff, and operating room facility is thoroughly vetted prior to being approved. The investigator surgeon is responsible for collecting and reporting data to manufacturer and the IRB. They are required to submit extensive paperwork and stay in touch with each patient throughout the duration of the study. Another possible limiting factor for patient enrollment is the location of the surgeon. Many surgeons require patients who enroll in a clinical trial to live locally. Clinical trials require long term follow-up, meaning a patient would have to live close enough to reliably commit to making the annual follow-up visit to see their surgeon.

The Devices in Breast Implant Clinical Trials are Not Experimental

Just because a device has not yet received FDA approval, does not mean it is an experimental device. Many implants have been studied, approved, and are widely used in Canada, Europe, Asia, and Australia before they ever receive clearance from the FDA for sale in the United States. “Many of the implants and devices that require clinical trials in in the US are devices that have been used in sometimes up to sixty other countries for several years, before they come to the US,” clarifies Dr. Glicksman.

Enrolling in Breast Implant Clinical Trials Does Not Mean Free Surgery

While some breast implant clinical trials may provide implants to participants free of charge, patients will typically still be responsible for the cost of the surgery. “Subjects are responsible for their routine surgical costs,” explains Dr. Glicksman, “but patients enrolled in a clinical trial will generally be compensated at each annual visit for their time, their effort, and their commitment to the long-term study.”

The actual compensation that a participant in a breast implant clinical trial receives varies among clinical trials. In most cases, the subjects are compensated for their time and effort and a participant may receive payment after they have completed each annual follow up visit.

Clinical Trials are a Big Commitment

As a participant in a clinical trial, subjects are committing to a long-term relationship with their plastic surgeon. “You have to love your surgeon,” emphasizes Dr. Glicksman. “You have to be committed to going back each year. The advantage of enrolling in a clinical trial is that you certainly are getting cutting edge technology, and you develop a close bond with your surgeon. You know you’re going to be carefully followed for many, many years.”

Depending on what part of a clinical trial a patient enrolls in, they may also be required to do more than just visit with their surgeon and fill out some paperwork each year. Some studies require enrolled patients to undergo additional testing, such as an MRI, as part of the patient follow-up. Anyone considering enrolling in a clinical trial should fully understand the early and long-term requirements of the study.

Clinical Trial Experience Can Make Your Plastic Surgeon A Better Surgeon

“From the surgeon’s standpoint as a clinical investigator, these studies are probably the best way to get accurate data on these devices to determine their long-term safety and effectiveness for patients,” concludes Glicksman.  “I’ve also learned from being an investigator in multiple breast implant trials that watching and closely following my patients over the years has made me a better surgeon.”