Important Factors You Should Consider When Choosing Saline-Filled or Silicone Gel-Filled Breast Implants
For many women, breast implant surgery brings great rewards, both physically and emotionally. However, it is important to consider the risks, as well as the benefits, before making your decision to have breast augmentation surgery. There are many important factors to consider before choosing saline-filled or silicone gel-filled breast implants:
· Breast implants are not lifetime devices, and breast implantation is not necessarily a one-time surgery. You will likely need additional surgeries on your breasts due to complications or unacceptable cosmetic results. These additional surgeries can include implant removal with or without replacement, or other surgical procedures.
· Many of the changes to your breasts following breast implantation are irreversible. If you later choose to have your breast implants removed and not replaced, you may experience unacceptable dimpling, puckering, wrinkling or other cosmetic changes of the breast, which may be permanent.
· Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
· Rupture of a silicone gel-filled breast implant is most often silent. This means that neither you nor your plastic surgeon will know that your breast implants have a rupture. In fact, the ability of a plastic surgeon that is familiar with breast implants to detect a silicone gel-filled breast implant rupture through a physical examination is 30%, compared to the 89% ability of an MRI to detect a rupture. You will need regular MRI screenings over your lifetime in order to determine if silent rupture is present. You should have your first MRI three years after your initial breast augmentation surgery and then every two years thereafter.
· The health consequences of a ruptured silicone gel-filled breast implant have not been fully established.
· If breast implant rupture is noted on an MRI, you should have the implant removed, with or without replacement.
· With breast implants, routine screening mammography for breast cancer will be more difficult. If you are of the proper age for mammography screening, you should continue to undergo routine mammography screenings as recommended by your primary care physician. The breast implant may interfere with finding breast cancer during mammography and because the breast and implant are squeezed during mammography, an implant may rupture during the procedure.
· You should perform a self-examination of your breasts every month for cancer screening. However, this may be more difficult with breast implants. You should ask your plastic surgeon to help you distinguish the implant from your breast tissue.
· You should perform a self-examination of your breasts for the presence of lumps, persistant pain, swelling, hardening, or change in implant shape, which may be signs of a rupture of the implant. These signs should be reported to your surgeon and possibly evaluated with an MRI.
· After undergoing breast implant surgery (either primary or revision), your health insurance plan premiums may increase, your insurance coverage may be dropped, and/or future coverage may be denied. Additionally, treatment of complications may not be covered.
· You should inform any other doctor who treats of you of the presence of your breast implants to minimize the risk of damage to the implants.
· Allergan will continue its ongoing Core Study through 10 years to further evaluate the long-term safety and effectiveness of these products. In addition, Allergan has initiated a separate, 10-year postapproval study to address specific issues for which the Allergan Core Study was not designed to fully answer, as well as to provide a real-world assessment of some endpoints. The endpoints in the large postapproval study include long-term local complications, connective tissue disease (CTD), CTD signs and symptoms, neurological disease, neurological signs and symptoms, offspring issues, reproductive issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and results. Allergan will update their labeling on a regular basis with the results of these two studies. You should ask your surgeon if he/she has any available updated Allergan clinical information.
· It is important that you read the entire MAKING AN INFORMED DECISION ON SALINE-FILLED BREAST IMPLANT SURGERY or the entire IMPORTANT INFORMATION FOR WOMEN ABOUT BREAST AUGMENTATION (OR RECONSTRUCTION) WITH INAMED SILICONE-FILLED BREAST IMPLANTS because you need to understand the risks and benefits, and have realistic expectations for your breast augmentation surgery.
Inamed Silicone-Filled Breast Implants are indicated for Females for the Following Uses:
· Breast Augmentation for women at least 22 years old
o Breast augmentation includes primary breast to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
· Breast Reconstruction.
o Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma 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 a primary breast reconstruction surgery.
· Breast Augmentation for women at least 18 years old.
o Breast augmentation is done to increase the size and proportion of a woman's breasts.
· Breast Reconstruction.
o Breast Reconstruction is done to restore a woman's breast shape after a mastectomy or injury that resulted in either partial or total loss of the breast(s) or to correct a birth defect.
Contraindications
Breast implant surgery should NOT be performed in:
· Women with active infection anywhere in their body.
· Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions.
· Women who are currently pregnant or nursing.
Precautions
Safety and effectiveness have not been established in patients with the following:
· Autoimmune diseases (for example, lupus and scleroderma)
· A weakened immune system (for example, currently taking drugs that weaken the body's natural resistance to disease)
· Conditions that interfere with wound healing and blood clotting
· Reduced blood supply to breast tissue
· Radiation to the breast following implantation.
· Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your plastic surgeon prior to breast augmentation surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait for resolution or stabilization of these conditions prior to undergoing breast augmentation surgery.