Breast implants safety information

Breast implants are not lifetime devices. The longer a woman has implants, the more likely it is that she will need to have surgery to remove them.

The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture with deflation, wrinkling, asymmetry, scarring, pain, and infection. In addition, women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).

There is no apparent association between saline-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, in order to rule out these and other rare complications, studies would need to be much larger and longer than those conducted so far.

Safety Studies

Each year, thousands of women undergo breast augmentation surgery and experience no major complications. However, one must fully understand the risks as well as the benefits of this procedure. A recent study with a follow-up of at least ten years showed that nearly 96 percent of women with saline-filled breast implants who were surveyed would make the same choice again. This study was performed at the University of Minnesota in consultation with the Food and Drug Administration (FDA). Of 450 patients, 93 percent reported they were satisfied or very satisfied with their breast implants, and 71 percent rated their breast implants as soft and natural.

After a comprehensive evaluation of the evidence for the Association of Silicon Breast Implants with human health conditions, the Institute of Medicine concluded in June that there is "no definitive evidence linking breast implants to cancer, neurological diseases, neurological problems or other systemic diseases."

Many of the changes to the breast following implantation should be considered irreversible. If it is necessary or one chooses to have the implants removed, there may be dimpling, puckering or wrinkling, or other changes to the breast. Breast implants may affect the ability to produce milk for breast feeding. Breast implants may not prevent your breasts from sagging after pregnancy.

Long-Term Effects

There are millions of women who have had this surgery done since the 1970s who continue to live in harmony with their implants.

Breast augmentation may not be a one-time surgery. It is possible that there will be a need for additional surgery and doctor visits over the course of your life.
Breast implants should not be considered lifetime devices. It is possible that a woman will undergo implant removal with or without replacement over the course of her life.



What is a breast implant?

Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery.

There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, and shape (contour).

Saline-filled, silicone gel-filled, and alternative breast implants may be indicated for breast augmentation and/or breast reconstruction, which are defined as follows:

Breast augmentation. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of an original primary breast augmentation surgery (i.e., revision-augmentation).

Breast reconstruction. Breast reconstruction includes 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. Breast reconstruction also includes revision surgery to correct or improve the result of an original primary breast reconstruction surgery (i.e., revision-reconstruction).

Sources: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/default.htm
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