Safety Summary—INAMED^® Silicone-Filled Breast Implants

This summary is designed to help answer some of the questions you may have about the risks of surgery with INAMED^® Silicone-Filled Breast Implants. For a complete review of the risks and benefits please read Important Information for Women About Breast Augmentation (or Reconstruction) with INAMED^® Silicone-Filled Breast Implants available from Dr. Zevon or directly from Allergan at 800.362.4426.

You should carefully review and consider the complete risk information found in Important Information for Women About Breast Augmentation (or Reconstruction) with INAMED^® Silicone-Filled Breast Implants, before deciding whether to have breast surgery unless Dr. Zevon finds it medically necessary to perform surgery sooner (as may be the case in a revision surgery).

INAMED^® Silicone-Filled Breast Implants are indicated for females for the following uses (procedures):

• Breast augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
• 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 a primary breast reconstruction surgery.

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 Dr. Zevon prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.

IMPORTANT FACTORS YOU SHOULD CONSIDER IN CHOOSING SILICONE GEL-FILLED IMPLANTS.

• Breast implants are not lifetime devices, and breast implantation is likely not a one-time surgery. You will likely need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. These additional surgeries can include implant removal with or without replacement, or they can include other surgical procedures.
• Many of the changes to your breast following implantation are irreversible (cannot be undone). If you later choose to have your implant(s) removed and not replaced, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which can 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 Dr. Zevon will know that your implants have a rupture most of the time. In fact, the ability of a physical examination by a plastic surgeon who is familiar with breast implants to detect silicone breast implant rupture is 30% compared to 89% for an MRI. You will need regular screening MRI examinations over your lifetime in order to determine if silent rupture is present. You should have your first MRI at 3 years after your initial implant surgery and then every 2 years, thereafter.
• The health consequences of ruptured silicone gel-filled breast implants have not been fully established.
• If 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 implant may interfere with finding breast cancer during mammography. Because the breast and implant are squeezed during mammography, an implant may rupture during the procedure.
• You should perform an examination of your breasts every month for cancer screening; however, this may be more difficult with implants. You should ask Dr. Zevon to help you distinguish the implant from your breast tissue.
• You should perform an examination of your breasts for the presence of lumps, persistent pain, swelling, hardening, or change in implant shape, which may be signs of symptomatic rupture of the implant. These should be reported to Dr. Zevon and possibly evaluated with an MRI to screen for rupture.
• After undergoing breast surgery (either primary or revision), your health insurance premiums may increase, your insurance coverage may be dropped, and/or future coverage may be denied. Treatment of complications may not be covered as well.
• You should inform any other doctor who treats you of the presence of your 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 also ask Dr. Zevon if he has any available updated Allergan clinical information.
• It is important that you read 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 to have realistic expectations of the outcome of your surgery.

Safety Outcomes
The tables below provide a summary of the risk of occurrence of the most common complications associated with surgery with silicone gel-filled breast implants.

Primary Augmentation / Revision-Augmentation
4-Year Complications by Patient

Primary Reconstruction / Revision-Reconstruction
4-Year Complications by Patient