Reduce your risk: Breast implant surgery

The FDA recently announced that it has approved the marketing of silicone gel-filled breast implants manufactured by Mentor and Allergan (formerly Inamed). This was a complex, multi-faceted decision. The FDA announcement summarized risks of the surgical procedure and also mentioned the recommendations for post-surgical care.

The announcement is available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01512.html

The FDA offers many sources of advice on the issue of implant risks and benefits and general patient safety. These resources are available on the FDA’s “Breast Implants Home Page” at http://www.fda.gov/cdrh/breastimplants/.

Specific information from the implant manufacturers is available on their websites.

Mentor
http://www.mentorcorp.com/index-aesthetics.htm

Allergan
http://www.allergan.com/site/products/consumers/home.asp?id=silicone_breast_implants

Both sites offer links to other websites containing voluminous information, including physician referral tools, “before and after” photographs, and patient information on the risks and benefits of breast surgery. Two key resources are the physician product information and patient product information.

The Mentor “product insert data sheet” is more than 50 pages, and can be found at http://www.memorygel.com/PDF/PIDS.pdf. This document contains detailed instructions to physicians on patient counseling, including the admonition, “Before making the decision to proceed with surgery, the surgeon or a designated patient counselor should instruct the patient to read Important Information for Augmentation/Reconstruction Patients About Mentor MemoryGel Silicone Gel-Filled Breast Implants.”

Informed Consent
The physician labeling in the manufacturer’s brochure includes some comments that appear to leave little room for physician judgment regarding patient counseling. The brochure directs physicians to “…allow the patient at least 1-2 weeks after reviewing and considering this information before deciding whether to have primary breast augmentation surgery…”

The manufacturer also directs physicians to document informed consent by stating, “In order to document a successful informed decision process, the patient labeling includes an Acknowledgment of Informed Decision form at the end of the document, which is signed by both the patient and the surgeon and then retained in the patient’s file.” In addition, there is a CME requirement, Mentor’s Device Access Education Course, which physicians must take, “…in order to gain access to…” the Mentor product.

The Mentor labeling states:
“Breast implantation is an elective procedure and the patient must be thoroughly counseled on the risks, as well as the benefits, of these products and procedures. You should advise your patient that she must read the patient brochures for either augmentation or reconstruction, as applicable. You must read the patient brochures in their entirety.”

From a legal standpoint, the foundation of any surgeon’s informed consent process must be the manufacturer’s product labeling, as well as the state mandated consent forms. It would be difficult for a surgeon to justify any system of patient education that failed to include the manufacturer’s brochure.

Although the brochure is lengthy, it would be advisable to provide each patient a hard copy of the brochure. It is likely that the product manufacturer will make copies of the patient information available to the surgeons. Surgeons and patients will benefit from using the manufacturer’s consent form. A copy of the form should be kept in the permanent patient record.

Follow-up care
In the discussion on postoperative care, the manufacturers advise screening for implant rupture with an MRI. They recommend that an MRI be done 3 years after the surgery and every 2 years thereafter. Additionally, the manufacturers are more direct in their advice in the event of an implant rupture by stating if a rupture or evidence of rupture is found, “…you [the surgeon] should remove the implant and any gel…”

Risk Management recommendations
• One to two weeks before surgery, give the patient the manufacturer-provided consent form, Important Information for Augmentation/Reconstruction Patients About Mentor MemoryGel Silicone Gel-Filled Breast Implants, located at http://www.mentorcorp.com/pdf/approved/Augmentation.pdf or Important Information for Women About Breast Augmentation with INAMED Silicone-Filled Breast Implants, located at http://www.breastimplantstoday.com/pdf/M1209-02SiliconeAugLabel.pdf.

• After the patient has had time to review the information, provide an opportunity for her to ask questions.

• Have the patient sign the manufacturer-provided consent form.

• Give the patient a copy of the consent form and maintain a copy in the permanent patient record.

• Document that the patient received, read, and understood the manufacturer’s consent form.

• Document that the patient had an opportunity to ask questions and that questions were satisfactorily answered.

• Follow the manufacturer’s recommendation for patient follow-up.

• Document that the patient was instructed on the manufacturer’s recommendations for MRI follow-up at 3 years and every 2 years thereafter.

• Develop a patient notification system for manufacturer recommended follow-up MRIs. Document patient notification in the permanent patient record.

• Follow the manufacturer’s printed information, not what the manufacturer’s sales representatives tell you.

• Obtain the most current version of the manufacturer’s consent forms.

• Stay current on any labeling changes and FDA warnings on adverse events.

The above guidelines are suggested practice protocols based upon the current scientific evidence and the known legal environment. Physicians are urged to adopt these protocols, recognizing that physician medical judgment must govern practice decisions.