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Breast Implants



Breast implants are medical devices that are implanted either under breast tissue or under the chest muscle for breast augmentation or reconstruction. There are two major types: saline-filled and silicone gel-filled. Saline-filled breast implants are silicone shells that are either prefilled or filled with saline during surgery, and some of these allow for adjustments of the filler volume after surgery. Silicone gel-filled breast implants are silicone shells prefilled with silicone gel. Breast implants vary in profile, size, and shell surface (smooth or textured).


FDA has approved four breast implants for marketing in the U.S.:


•In May 2000, Mentor and Allergan (formerly Inamed) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age.


•In November 2006, Allergan and Mentor received approval for their silicone gel-filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age.

All breast implants other than these four approved devices are considered investigational devices, including the more-cohesive (“gummy bear”) implants. For a woman to receive a Breast implants they must be used for:

•primary augmentation (to increase breast size for cosmetic reasons)

•revision-augmentation ( revision surgery to correct or improve the result of an original breast augmentation surgery)

•primary reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality)

•revision-reconstruction ( revision surgery to correct or improve the result of an original breast reconstruction surgery).


There are restrictions on the age for breast implants. The FDA approved saline-filled breast implants for augmentation in women ages 18 and older. FDA approved silicone gel-filled implants for women ages 22 and older. The age restrictions are different because the risks are different for the two products. For example, silicone gel-filled implants will require frequent MRI monitoring to detect silent rupture (a rupture that can go undetected by you or your doctor). There is no risk of silent rupture for saline-filled implants. In addition, the health consequences of a ruptured saline-filled breast implant are different from those of a ruptured silicone gel-filled breast implant.


Some of the risks of breast implants include:

•reoperations (additional surgeries), with or without removal of the device

•capsular contracture (hardening of the area around the implant)

•breast pain

•changes in nipple and breast sensation

•rupture with deflation for saline-filled implants

•rupture with or without symptoms for silicone gel-filled implants

•migration of silicone gel for silicone gel-filled breast implants.

If your saline-filled breast implant ruptures, you or your doctor will be able to tell. When saline-filled breast implants rupture, they deflate and the saline solution leaks into your body immediately or over a period of days. You will notice that your implant loses its original size or shape.

If your silicone gel-filled breast implant ruptures, it is likely that neither you nor your doctor will know. This is known as a silent rupture. This is why MRI is recommended at three years after implantation and then every two years thereafter to screen for rupture. However, sometimes there are symptoms. These symptoms include hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening of the breast.

Platinum is a metal used in the manufacture of the shell and gel components of silicone breast implants. FDA fully evaluated the scientific literature on platinum. Based on the existing literature, FDA believes that the platinum contained in the implant shell and gel is in the zero oxidation state, which poses the lowest health risk. This is further supported by the available biocompatibility testing, gel bleed testing, and clinical data on these implants.


Some important factors to consider when making the decision to get implants include:


•Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to complications or unsatisfactory cosmetic outcomes.

•Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implants removed and not replaced, your breasts will not change back to the way they looked before your implant surgery. You may have permanent dimpling, puckering, wrinkling, or other cosmetic changes.


•When you have your implants replaced (revision), your risk of complications increases compared to your first (primary) surgery.

•Routine mammograms to screen for breast cancer will be more difficult with breast implants.

•Breast implants may affect your ability to breast feed, either by reducing or eliminating milk production.

Factors to consider specifically about silicone gel-filled breast implants include:

•If your silicone gel-filled breast implant ruptures, you may have no symptoms. This is called a silent rupture because, most of the time, neither you nor your doctor will know that your implant has ruptured.

•The best way to determine whether or not your silicone gel-filled implant has ruptured is with an MRI examination. You should have your first MRI three years after your implant surgery and every two years thereafter.

•Over your lifetime, the cost of MRI screening may exceed the cost of your initial surgery. This cost may not be covered by medical insurance.