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 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 FDA’s 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."
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