Breast Implant Education

Media Statement from Mentor Worldwide LLC 6-22-2011

Mentor Worldwide, a global leader in breast aesthetics, welcomes the news from the U.S. Food and Drug Administration that confirms silicone gel-filled breast implants are safe and effective when used as intended. The analysis provided by the FDA is consistent with previous studies examining the safety of breast implants and adds to our collective scientific knowledge of these products.

We concur with FDA that women should fully understand that there are potential risks associated with breast implants, and they should discuss the risks and benefits with their plastic surgeon prior to breast augmentation or reconstruction.

We also agree with FDA about the importance of follow up in post-approval studies and will continue to work with the FDA, physicians, and patients to help increase the follow-up rates. The information gathered in follow-up visits continue to provide valuable information about the long-term safety of implants.

Statement about Follow-up Rates in Post-Approval Studies

Since launching its post-approval studies, Mentor has communicated to the women in these studies and their physicians about the importance of following up. However, patient follow-up has been a challenge for all breast implant post-approval studies. At Mentor’s request, letters from the FDA were sent to physicians and patients to encourage follow-up and state the importance of follow-up; unfortunately, there was minimal impact with respect to the follow-up rate. We continue to encourage women to participate in these studies.

Typically, it is not the standard of care for breast implant patients to visit their physician annually. Patients most likely to follow up with their physician are those who experience complications. We concur with the FDA that the local complications observed in the silicone gel-filled breast implant post-approval studies are consistent with complications noted at the time of approval.

The following breast implant education information is from the American Society of Plastic Surgeons, the largest plastic surgery specialty organization in the world. Dr. Christine Sullivan supports the following thoughts and comments from the ASPS on the safety of breast implants:

FDA Communication

1. ASPS and ASAPS share the FDA’s commitment to patient safety, and we look forward to collaborating with the FDA to ensure that science informs our decision-making.
2. Breast implants are the most studied device in the history of medicine.
3. Both the FDA and the ASPS/ASAPS are confident that breast implants are safe and effective.

Plastic Surgery Action

1. ASPS is taking steps in concert with FDA to establish a national registry for breast implants.
2. The safety and satisfaction of our patients is our primary focus. We are focusing on the science and will get the facts for our patients.
3. The ASPS strongly supports ongoing monitoring and research of breast implants.

What Patients Should Do

1. Women considering implants should do their homework and consult with an ASPS/ASAPS member surgeon.
2. Women with implants should continue their normal routine—self exam and mammography when appropriate.
3. Women should monitor their implants, and if they detect changes, they should contact their plastic surgeon.

Breast Implant Concerns

1. ALCL associated with breast implants is extremely rare. A woman is more likely to be struck by lightning than get this condition.
2. The true incidence of this condition is unknown.
3. Plastic surgery agrees with the FDA that this condition is extreme rare and is not breast cancer.
4. Of the estimated 10 million implants worldwide, only 34 cases of ALCL have been identified since 1989.
5. Even though breast implants are the most studied devices in history, we support the collection of additional information in a scientific fashion.
6. For the most current information and recommendations about breast implants, visit plasticsurgery.org or surgery.org. You can also schedule a consultation with  Dr. Christine Sullivan.