FDA Publishes New Handbook on Breast Implants (dateline September 13, 2000)
The U.S. Food and Drug Administration (FDA) has published a new brochure that addresses vital information on breast implants. The 2000 government brochure entitled, "Breast Implants: An Information Update," discusses several aspects of breast implants, including which brands are currently FDA approved and the potential complications that may occur with breast implants.
Currently, only two brands of saline (salt water) filled breast implants are FDA approved for general use: those made by Mentor Corporation and those made by McGhan Medical. The FDA imposed a ban on the general use of silicone gel-filled breast implants in 1992 after questions arose about the safety of the implants. Silicone-filled breast implants are currently only available to women who participate in closely monitored clinical trials.
The FDAs new brochure appears when implant surgery is at an all-time high. Nearly 150,000 American women received breast implants in 1999, up from 125,000 women before silicone implants were banned. Implants may be placed in women who wish to enhance the size and shape of their breasts as well as in many breast cancer patients who have had one or both breasts surgically removed (mastectomy). Approximately 15,000 breast cancer patients chose to have breast implants placed after mastectomy in 1999 while around 135,000 women had implant surgery for cosmetic reasons.
According to the FDA, the brochure contains the latest information on breast implants and is designed to assist women in making informed decisions about whether or not to get breast implants. Topics of the brochure include:
- The status and availability of implants
- Implant surgery
- The status of saline, silicone, and alternative implants
- Breast implant risks
- Specific issues to consider (such as choosing a plastic surgeon and questions to ask the surgeon before the operation)
- Reporting of serious implant problems
- Chronology of FDA activities related to breast implants
- Breast implant resource groups
In the section on breast implant risks, the FDA discusses the frequency of capsular contracture (hardening of scar tissue around the implant), implant deflation/rupture/leakage, additional surgeries, pain, infection, changes in breast or nipple sensation, calcium deposits around the implant, and more.
In a study conducted by Mentor, a manufacturer of breast implants, 27% of 1,680 women with saline implants had to have them removed or replaced within three years of implantation. In the majority of cases, painful scar tissue, infections, and implant ruptures were the causes of additional surgeries. According to Mentor, the women at most risk of implant complications in the study were breast cancer patients who accounted for 27% of the implant removals; only 8% of the removals were done on women who had implants placed for cosmetic reasons.
According to the FDA brochure, "while many women believe breast implants cause debilitating systemic illnesses, such as autoimmune disease, this is not proven at this time. However, most women with breast implants will experience some local complications such as rupture, pain, capsular contracture (a tightening of the scar tissue or capsule the body forms around the breast implant), disfigurement, and serious infection. These may lead to nonsurgical medical treatments and repeat surgeries."
- The FDAs breast implant brochure and supplemental information on breast implants, including photographs of implant complications, are available free of charge at http://www.fda.gov/cdrh/breastimplants/
- To learn more about breast reconstruction with implants, please visit http://www.imaginis.com/breasthealth/reconstruction.asp
- To learn more about breast augmentation surgery with implants, please visit http://www.imaginis.com/breasthealth/augmentation.asp
- To learn more about breast implant imaging, please visit http://www.imaginis.com/breasthealth/breastimplant1.asp