Breast Implant Safety Information

For the past several years, there have been many reports in the media about women with breast implants who have autoimmune disease or breast cancer. Also during this time, many respected medical professionals and institutions have conducted scientific studies about the safety of breast implants. Mentor is pleased to be able to provide the public with up-to-date information about breast implant studies.

National Cancer Institute

The National Cancer Institute recently completed a study of 13,500 women who received silicone gel implants for cosmetic reasons prior to 1989. Researchers found no significant increase in breast cancer incidence or mortality. More information on this study can be found at
www.nci.nih.gov/newscenter/siliconefactsheet

Institute of Medicine

In June 1999, the National Academy Institute of Medicine issued a report that included the following conclusion: "In an overall consideration of the epidemiological evidence, the committee noted that because there are more than 1.5 million adult women of all ages in the United States with silicone breast implants, some of these women would be expected to develop connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions. Evidence suggests that such diseases or conditions are no more common in women with breast implants than in women without implants." The full text of the publication, "Information for Women About the Safety of Silicone Breast Implants – A Report of a Study by the Institute of Medicine," is available online at www.nap.edu.

National Science Panel

In October 1996, Judge Sam C. Pointer Jr., the coordinating judge for federal breast implant litigation, established the Rule 706 National Science Panel. The purpose of this panel was to investigate scientific data about breast implants and their possible relation to connective tissue diseases and immune system dysfunction.

The panel reviewed over 2,000 medical documents and heard testimony from legal, medical and scientific experts. The panel released their findings in November 1998, and concluded that there are no identifiable associations between the use of silicone implants and disease.

Independent Review Group

The Independent Review Group (IRG) on Silicone Breast Implants was assembled by the Chief Medical Officer of the UK to review the possible health issues associated with silicone gel breast implants. Members of the IRG were selected for their independent views, their knowledge and understanding of the issues, and lack of any financial interest in the conclusions they reached.

Led by Professor Roger D. Sturrock, MD, FRCP, the IRG reported in 1998 that there is no scientific evidence of an association between silicone gel-filled breast implants and any established connective tissue disease. The complete report is available on the Internet at http://www.silicone-review.gov.uk.

European Committee on Quality Assurance

In July 1998, the European Committee on Quality Assurance and Medical Devices in Plastic Surgery released a report that contained the following conclusions: "There are conclusive scientific—clinical, immunological, epidemiological—data, that silicone gel-filled breast implants do not cause any autoimmune nor connective tissue diseases." Their report also stated, "Updated studies continue to show that silicone gel-filled implants do not cause cancer nor other malignant disease." The entire declaration can be found on the Internet at http://www.worldplasticsurgery.org.

Mentor

Over the years, Mentor has done a very thorough safety evaluation of both saline-filled breast implants and gel-filled breast implants. In addition to our own testing, Mentor has sponsored other state-of-the-art tests performed at leading academic institutions. The largest of these studies is a clinical study of more than 70,000 women with silicone gel-filled breast implants. This study was established by Mentor in 1992 in cooperation with the U.S. Food and Drug Administration (FDA).

Mentor also has conducted extensive investigations of saline-filled breast implants involving nearly 5,000 patients. The general objective of these studies was to gather information about the safety and effectiveness of breast implants. Mentor saline breast implants have received PMA (premarket application) approval from the FDA.

For important information on the benefits and risks associated with saline-filled breast implant surgery, read our document called "Saline-Filled Breast Implant Surgery: Making an Informed Decision". A copy of the product package insert, "Mentor Saline-Filled and Spectrum® Mammary Prostheses," may be viewed in the Products section of this web site.

As we have for many years, Mentor will remain committed to providing the public with objective information about breast implant safety.

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For important information on the benefits and risks associated with breast augmentation surgery, read our documents called "Important Information for Augmentation Patients about Mentor MemoryGel® Silicone Gel-Filled Breast Implants" and "Saline-Filled Breast Implant Surgery: Making an Informed Decision"

You may download a copy of the product package insert "Mentor MemoryGel<sup>®</sup> Silicone Gel-Filled Breast Implants", or for saline-filled breast implants "Mentor Saline Filled and Spectrum® Mammary Prostheses."