In 1992, responding to claims that silicone gel-filled breast implants had harmed tens of thousands of women, the Food and Drug Administration (FDA) banned the marketing of the devices for breast augmentation.
Fourteen years and mountains of safety data later, the FDA relaxed its stance, approving two manufacturers' applications to market silicone gel-filled implants for breast augmentation once again. The implants had remained available for breast reconstruction following mastectomy, as well as for women enrolled in certain clinical trials, throughout the ban. Saline-filled implants stayed on the market all along, used with FDA approval for either breast augmentation or breast reconstruction.
Not surprisingly, the rise and fall of the ban on silicone gel-filled breast implants left many women with unanswered questions. What are the risks of breast-augmentation surgery, and are those risks increased with either type of implant? How do you choose between silicone gel-filled and saline-filled implants? Here Molly Walsh, D.O., a plastic surgeon at Mayo Clinic in Rochester, Minn., explains some of the differences between these two types of breast implants.
- Who can get silicone gel-filled breast implants?
Why the age restriction on silicone gel-filled implants for breast augmentation? One reason is because a woman's breast tissue continues to develop into her early 20s. But the age restriction is a bit arbitrary. FDA officials felt that at age 22, most women could make a fully informed decision about getting breast implants — including the risks and ongoing costs associated with the procedure.
- Who can get saline-filled breast implants?
FDA officials say the age restrictions for saline-filled and silicone gel-filled breast implants differ because the two types of breast implants carry different risks.
- What's the difference between the two types of breast implants?
Silicone gel implants also consist of a silicone outer shell, but they're pre-filled with a silicone gel rather than saline. Silicone gel has a viscosity — a thick, sticky fluid consistency — that closely mimics human fat, which is a large component of female breast tissue. Saline, on the other hand, isn't compressible and gives a more firm impression.
Some women claim that silicone gel-filled breast implants look and feel more like natural breast tissue. Saline-filled implants have been criticized for feeling hard or unnatural, although improved surgical techniques — such as placing the implant behind the chest muscle and slightly overfilling it — have lessened these complaints.
- How does the plastic surgeon decide whether the implant will be placed behind the chest muscle (subpectoral) or with the breast tissue (subglandular)?
A combination of factors is considered when determining implant placement, including:
* Anatomy of your breasts, including amount of breast tissue
* Type of implant: saline or silicone gel
* Size of the implant
- What are the risks of breast implants?
* Implant rupture
* Need for additional breast surgery
* Scar tissue that hardens around and distorts the breast implant (capsular contracture)
* Breast pain
* Decreased nipple or breast sensation
* Infection
If you have saline-filled implants, implant deflation may be a concern. If you have silicone gel-filled implants, a rupture could mean that silicone gel leaks outside of the implant's silicone shell. However, there's no evidence that free gel poses any risks beyond
those of an intact silicone shell — and neither one leads to autoimmune disease. That's why the FDA re-approved the use of silicone gel-filled implants.
Thanx to the Mayo Clinic staff.
www.mayoclinic.com
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