FDA Hearings on Silicone Gel Implants

This past week the FDA has been hearing testimony regarding the safety and ongoing studies of silicone gel implants. In summary, they have found them to be safe and recognize the need to continue the follow up studies of women who have already been enrolled. I have copied the bulletin I received from the President of the American Society of Aesthetic Plastic Surgery which summarizes the hearings and includes a link to the actual FDA proceedings. I hope this helps to aleviate fears of women who either have these implants or are considering them for themselves in the future. You may also learn more about breast implant surgery by going to http://www.cosmeticsurgerybaltimore.com//procedures/breast-surgery/breast-augmentation/


ASAPS E-Bulletin
From Dr. Jeffrey Kenkel, President of ASAPS
September 8, 2011

Aesthetic Society Members Testified at the FDA Panel on Breast Implants

The Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee conducted a panel hearing on silicone gel-filled breast implants last week. The purpose of the hearing was to evaluate the progress of long-term post-approval market studies mandated when silicone gel-filled breast implants were approved by the Agency to return to market in 2006. A key focus of the hearings, which included testimony from breast implant manufacturers, plastic surgeons and the public, was discussing innovative approaches to gathering data for future post-approval studies.

After two days of discussion and testimony about how to improve silicone breast implant study compliance, agency officials said silicone breast implants were safe and the studies would continue. “Women should feel assured that the F.D.A. continues to believe that currently marketed silicone breast implants are safe,” said William Maisel, MD, MPH, chief scientist in the FDA’s Center for Devices and Radiological Health, in remarks after the meeting. “The current post-approval studies will continue. The FDA is committed to seeing them completed and making sure the follow-up rates improve.”

Many experts at the hearings sighted the current labeling for MRI screening as unrealistic for healthy, asymptomatic patients. The panel agreed that patients should no longer be told that they should get an MRI three years after getting implants and every two years following. “F.D.A. continues to believe, as does the panel, that M.R.I. is the gold standard for evaluating breast implants for silent rupture,” Dr. Maisel said. “But there was consensus among the panel that the requirements for ongoing M.R.I.’s should be removed.”

Towards the end of the final day of the hearings, the FDA panel commented that they were impressed by the organization of the two plastic surgery societies, our message and our efforts to generate data and address important issues such as international registries, labeling compliance, patient confidentiality, and informed consent.

In addition to designated representatives from ASPS, the following Aesthetic Society Members testified at the hearings providing their perspectives from both a Society standpoint and individual plastic surgeon:

Jeffrey Kenkel, MD, president of the American Society for Aesthetic Plastic Surgery: Dr. Kenkel offered the FDA panel the ASAPS perspective on post approval studies, and thanked them for involving the Aesthetic Society in the collaborative work and participating in our educational venues. This collaborative work has reassured our physicians and patients about the safety of these devices.

V. Leroy Young, MD, president of the Aesthetic Surgery Education and Research Foundation: Dr. Young summarized the data we have confirming the safety and efficacy of silicone breast implants. He urged a collaborative approach with the agency, industry, plastic surgeons and other specialists to work out methodologies that will insure future studies are designed to capture as much clinical data as possible.

Laurie A. Casas, MD, past-president of the Aesthetic Surgery Education and Research Foundation: Dr. Casas listed the questions her patients ask about breast implants, and she outlined several outstanding issues that need to be answered in order to give our patients the answers to their clinically relevant questions.

William P. Adams, Jr., MD, vice president of the Aesthetic Surgery Education and Research Foundation: Dr. Adams presented current research being conducted with grant support from ASERF comparing MRI to high resolution ultrasound (HRUS), in detecting breast implant shell failure. He also recommended lifting the restriction on Betadine for breast implant irrigation.

Dennis C. Hammond, MD: Dr. Hammond started by reminding the panel that in more than 22 studies published in peer reviewed scientific literature, there has been no association between silicone implants and connective tissue disease. He also spoke about the challenges of maintaining enrollment of patients into the post approval studies, noting that it requires a significant commitment on the part of the practitioner.

Gloria Duda, MD: Dr. Duda discussed the importance of maintaining silicone gel breast implant availability to patients for both augmentation and reconstruction.

As I said during my testimony, “The collaborative work done in this area has reassured our physicians and patients about the safety of these devices. We are confident that innovation through research and dialogue among all involved will make these types of studies even more beneficial in the future. There is no argument as to our goal: patient safety and a better, informed patient.”

The FDA panel was very informative and highlighted some of the struggles we all have had with the post approval studies. I am confident that the FDA will take the discussion from the hearings and put together an improved process to access long term data on our silicone implant patients. We all must embrace the importance of the PAS and do our best to enroll our patients.

To find the FDA’s summary of the hearings click on the link below:
http://www.surgery.org/downloads/blasts/FDAPanelHearingsSummary.pdf