FDA Approves Silicone Gel Implants for Augmentation and Reconstruction

On November 17, 2006, the U.S. Food and Drug Administration (FDA) announced its approval of silicone gel implants for breast augmentation in patients over the age of 22 and for patients of any age for breast cancer reconstruction purposes.

Physicians who use silicone gel implants should be aware of the following important implications:

1. Physicians must complete the manufacturer’s training program to gain access to the implants.
2. Physicians must comply with the device tracking regulations, which require physicians to provide certain patient identifying information to the manufacturers for tracking purposes.
3. Patient education is to include the recommendation that an MRI be completed three years after implantation and every two years thereafter to monitor for implant rupture.
4. Both the patient and the physician must sign an acknowledgment of informed decision, which is to remain in the patient’s medical record.

The Doctors Company’s Department of Patient Safety recommends the following actions for physicians who are using or plan to use silicone gel implants:

1. Employ careful patient selection guidelines for use of the silicone gel implants.
2. Provide patients with the manufacturer’s educational information on the silicone gel breast implants in the manner set forth in the educational information.
3. Discuss the importance of and need for both mammography and the recommended MRI, and emphasize that it is the patient’s responsibility to inform her primary care provider of the implant(s) and of the recommended time frame for such routine testing.
4. Set up a tickler file to provide a reminder of when to notify the patient to schedule post-implantation MRIs. Keep a copy of the reminder in the patient’s record.
5. Provide the patient with a self-addressed, stamped envelope that can be mailed to you and the primary care provider in case of patient relocation.
6. Provide thorough informed consent with documentation that lists all of the known risks and complications as provided in the manufacturer’s labeling information.
7. Document in the patient’s medical record all discussion with the patient as to the risks, complications, benefits, and alternatives—including education as to the recommended follow-up testing.
8. Given the absence of clear direction from the FDA and specialty societies regarding who has responsibility for follow up with the patient and for ensuring the recommended MRI examination, physicians who perform the surgery should develop and implement a system to track patients for whom they insert silicone gel implants. A tracking system will ensure that patients receive the recommended follow up and the communication as to the time for the recommended MRI examination. The physician should document this contact with the patient in the medical record.

The Doctors Company has learned that the manufacturers may require the physicians to sign or acknowledge, as part of the physician certification process terms and conditions, a form that includes an indemnification and hold harmless provision for the manufacturer regarding any claims arising out of use of the Web site for education. Most policies of insurance do not cover liabilities assumed under contract. Any physician who elects to sign any hold harmless presented by an implant manufacturer should consult with his or her personal counsel before signing.

A complete text of the FDA approval and accompanying information, including patient labeling information, can be found at www.fda.gov/cdrh/breastimplants.

As always, we are available to answer any questions from our members, so please feel free to call your regional patient safety/risk manager in the Department of Patient Safety at (800) 421-2368, extension 1243, for assistance.

J6753 3/07

Print this page