The Susan G. Komen Breast Cancer Foundation Comments on Silicone Breast Implants
The Susan G. Komen Breast Cancer Foundation Comments on Silicone Breast Implants
International Patient Advocacy Organization Supports Informed Choice for Breast Cancer Patients
DALLAS - April 1, 2005 - The Susan G. Komen Breast Cancer Foundation supports the availability of silicone breast implants as an option for women considering reconstructive surgery due to mastectomy. Patients should be informed of risks associated with silicone breast implants and make all breast cancer treatment and reconstruction decisions together with their physician.
FDA hearings
On April 11-13, 2005, the Food and Drug Administration (FDA) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will hold hearings on two pre-market approval applications for silicone breast implants. In 2003, subsequent to a similar hearing, FDA advisers recommended that the ban on silicone breast implants be lifted and that sales be allowed only under certain conditions. The FDA rejected the advisory committee's recommendations.
The body of evidence
The overwhelming body of evidence does not support the existence of a link between silicone breast implants and major diseases of the body, such as systemic diseases and cancers. However, silicone breast implants may cause local complications, such as capsular contractions (a hardening or thickening of the tissue around the implant that could result in discomfort or changes in the shape of the implant) or ruptures that could necessitate additional surgeries. Mastectomy patients considering silicone breast implants should be educated about the higher risk of such complications and make informed decisions about whether silicone breast implants are right for them.
The Susan G. Komen Breast Cancer Foundation
"Breast reconstruction with silicone breast implants following mastectomy is a profoundly personal decision. Women must be provided with the necessary information so that they can weigh the risks and benefits associated with silicone breast implants and make an informed choice," said Diane Balma, breast cancer survivor and director of public policy for the Susan G. Komen Breast Cancer Foundation. "We must help women decide what is right for them based on knowledge and understanding of the latest information available."
In addition, the Komen Foundation advocates ongoing data collection, analysis and reporting based on the long-term follow-up of all women who receive silicone implants for breast reconstruction.
No conclusive evidence exists showing that implants have hindered nor delayed breast cancer detection. Mammograms are more difficult to perform on women with implants, yet this challenge can be overcome with special detection procedures.
The use of silicone implants
Approximately 20 percent of patients with breast implants receive them because of a breast cancer diagnosis or other medical need. Reconstruction of a breast removed by mastectomy and reconstruction of the non-diseased breast to restore symmetry, and treatment of any ensuing physical complications, are all part of the cancer treatment process. Some women and plastic surgeons choose silicone implants instead of saline implants because they feel silicone provides better symmetry, a more natural appearance and added comfort. Other women may elect to use a prosthesis rather than undergoing reconstructive surgery.
"Breast cancer treatment is a complex and multifaceted process," Balma said. "For women who choose it, reconstruction allows them to restore a sense of self and sexuality while mitigating the constant visual reminder of cancer."
