Breast implants — A Mayo Clinic specialist discusses implants for breast augmentation or reconstruction.
Molly Walsh, D.O.
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 saline-filled breast implants?
Like their silicone gel-filled counterparts, saline-filled breast implants carry an age restriction for use in breast augmentation. But in this case, you have to be at least age 18 to get saline-filled breast implants for breast augmentation. Saline-filled breast implants are available for women of any age for breast reconstruction.
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 factors should you consider before getting saline-filled or silicone gel-filled breast implants?
If you're thinking about having breast augmentation, it's important to become fully informed about what it means to have breast implants. Before you make your decision, consider the following:
- Breast implants aren't lifelong devices. Odds are you'll eventually need additional surgery to replace or remove your breast implants. Every woman's experience is different, but on average, breast implants last about 10 years before they need removal or replacement due to leakage or cosmetic issues. The operation to exchange old implants for new ones is relatively straightforward and requires less recovery time than does the initial surgery.
- Breast implants change more than just the size of your breasts. Over time, the presence of implants may alter the shape and feel of your breast, sometimes requiring additional surgery, which may include implant replacement. In addition, if you decide one day to have your implants removed, your breasts won't go back to their pre-implant appearance.
- Breast implants may interfere with breast cancer screening. Although implants can make physical detection of lumps easier, they also may complicate routine mammography to screen for breast cancer. Additional images offering special views of your breast are often necessary. The images may also be harder to interpret because cancers can be obscured by the implant itself. You might have to visit a specialized facility experienced in mammography for women with breast implants. Your doctor might also recommend additional imaging tests — such as ultrasound or magnetic resonance imaging (MRI) — to check for signs of breast cancer, and insurance may not cover these additional tests.
- Breast implants may hamper breast-feeding. You may experience decreased milk production, or you may not produce any milk at all.
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
How can you tell if a breast implant has ruptured?
If your breast implants are saline-filled, a rupture will likely be obvious. Your breast implant will become deflated, changing in size and shape as the saline solution leaks outside the shell of the implant. Though it's an obvious problem, the good news is that leaked saline solution is easily and safely absorbed by the body.
Silicone breast implant ruptures can be intracapsular — contained within the scar tissue surrounding the implant — or extracapsular, when the silicone leaks outside the scar tissue. Silicone gel implant ruptures are difficult to detect with a mammogram alone, and it's likely you won't have any signs that the implant has ruptured. This is called a "silent rupture." While some women experience subtle changes in the size, shape or contour of their breasts, magnetic resonance imaging (MRI) is usually necessary to identify the rupture and to help determine if it's intracapsular or extracapsular. Because intracapsular ruptures can become extracapsular if they're not addressed, doctors will usually recommend that ruptured implants be removed and replaced.
Because silicone gel-filled implant rupture is difficult to detect with a physical examination, women who get silicone gel-filled breast implants are encouraged to have MRI exams every two years, starting three years after implant surgery. The cost of MRI screening may not be covered by insurance.
How will safety of silicone gel-filled breast implants be monitored?
The FDA is requiring the two companies that manufacture the approved breast implants to conduct extensive follow-up studies. Over a 10-year period, each company will conduct a large-scale post-approval study comparing the silicone gel-filled implants with saline implants. Investigators will look for evidence of continued safety and effectiveness of these products.
Will there be other types of breast implants available in the future?
Another type of silicone gel-filled breast implant — called a "gummy bear" implant — is in development. The gummy bear implant consists of a more cohesive silicone gel, which is believed to help the implant better keep its shape over time. Currently, these breast implants are available only to women enrolled in clinical studies to test the product's safety and effectiveness. If these implants make it through the clinical trial phase, they could one day be available to other women considering breast implants.
Last Updated: 01/18/2008
