Learn how the ongoing study of silicone gel-filled breast implants provides continued assessment and reassurance of their safety.
Breast implant manufacturers are committed to further validating the long-term safety of silicone gel-filled breast implants and addressing any outstanding concerns women may have surrounding silicone gel-filled breast implants.
Following the approval of silicone gel-filled breast implants in the United States in 2006, manufacturers are conducting additional studies (referred to as "post-approval studies") to continue monitoring the performance of the devices. The United States Food and Drug Administration (FDA) sometimes requires post-approval studies to address important questions that can only be answered once a product is in broader use. What does this ongoing monitoring involve? Specifically, the manufacturers of silicone gel-filled breast implants have agreed to meet several requirements to collect additional safety data on the devices and ensure that information collected about the risk and benefit profile of silicone gel-filled breast implants be communicated to women so that they can make informed choices. These requirements, to which manufacturers of breast implants adhere, include:
- Continuing to follow women enrolled in the Core Clinical Studies through the 10-year evaluation period
- Continuing to study the performance of the devices
- Ensuring the patient information for silicone gel-filled breast implants is understandable to women who are considering breast implant surgery
- Ensuring that each patient has obtained the breast implant information and fully understands the risks associated with breast implant surgery
- Ending new enrollment in Allergan's pre-approval Adjunct Study and continuing to follow up with those women already enrolled through the 5-year evaluation period
Following the FDA's approval of silicone gel-filled breast implants, each company manufacturing these implants is required to conduct a large 10-year, FDA-endorsed study to collect data on the devices. The purpose of these studies, called "post-approval" studies, is to further monitor and validate the devices' long-term safety and effectiveness. Manufacturers are required to enroll thousands of U.S. patients through certified surgeons nationwide over a three-year period starting from the date of silicone gel-filled breast implant approval. In accordance with these requirements, Allergan, Inc. has initiated a robust 10-year prospective study referred to as the Breast Implant Follow-up Studies (BIFS) program. Allergan's BIFS program is one of the largest clinical studies ever undertaken, with the goal of enrolling approximately 50,000 patients.
Why is the number of study participants important? A large patient group allows the FDA and breast implant manufacturers to monitor potential statistical trends, and further validate earlier conclusions showing no association between silicone gel-filled breast implants and diseases or adverse events (e.g., connective tissue diseases, neurological disorders, etc.) that are otherwise rare among the general and studied patient populations.
The United States Food and Drug Administration (FDA) has put in place two important additional requirements to further ensure the safety of silicone gel-filled breast implants. As a result, companies that manufacture silicone gel-filled breast implants have created the following programs:
- A device-tracking program that makes it easier to promptly notify women about new safety information related to their breast implants, when needed.
- A certification program designed to educate and train physicians before they can gain access to silicone gel-filled breast implants or begin conducting implant surgery.
The recent approval of silicone gel-filled breast implants means that women now have a wide range of options for consideration for breast implant surgery. The decision about what breast implant option is best for you is one that needs to be thoroughly discussed with your surgeon.
Read an expert’s opinion on breast surgery considerations
Silicone gel-filled breast implants are among the most studied FDA-approved medical devices in existence. There are hundreds of peer-reviewed and published studies and reports examining and analyzing these devices, including robust epidemiological studies. Governmental bodies such as the U.S. Food and Drug Administration (FDA) and Health Canada, among others, evaluated these data and required the devices to meet strict regulations before approving them for wider use. These approvals provide additional validation and reassurance of silicone gel-filled breast implant safety.
In addition, silicone gel-filled breast implants have been available – in some instances for more than 25 years – in 60 countries worldwide. More than one million women around the world have chosen Allergan's silicone gel-filled breast implants to enhance or restore their breast shape. In addition, the safety of Allergan's silicone gel-filled breast implants is supported by the Company's extensive device testing, and nearly a decade of clinical studies conducted in the U.S. involving more than 80,000 women.
See a timeline of the evolution of silicone gel-filled breast implants
However, it is important to note that breast implants are not for every woman. Women considering breast implant surgery should consult with a plastic surgeon to determine if breast implants are the right option for them.
Be aware that a woman should not have breast implant surgery if she:
- Has existing malignant or pre-malignant cancer of the breast that has not been successfully treated
- Has an active infection anywhere in her body
- Is currently pregnant or nursing
In addition, because of the risks associated with conducting tests in women who have certain medical conditions, silicone gel-filled breast implants have not been clinically tested in women with:
- Autoimmune diseases, such as lupus or scleroderma
- Conditions that could interfere with wound healing and blood clotting
- A weakened immune system (such as women receiving immunosuppressive therapy)
- Reduced blood supply to the breast tissue
- Radiation to the breast following breast implant surgery
- 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 doctor prior to surgery.
As with any medical device or medical intervention, there are important factors and risks associated with silicone gel-filled breast implants and implantation surgery. You should be aware of these factors and discuss them with your surgeon if you have any concerns.
- 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 breast(s) 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 breast feed, either by reducing or eliminating milk production.
Read expert content on Pregnancy, Breastfeeding, and Children's Health
- Rupture of a silicone gel-filled breast implant is most often silent. This means that neither you nor your surgeon 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 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 screening 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, there is a minimal risk of implant rupture during the procedure.
Read an expert’s opinion on cancer and silicone gel-filled breast implants
- You should perform an examination of your breasts every month for cancer screening; however, this may be more difficult with implants. You should ask your surgeon to help you distinguish the implant from your breast tissue.
For more information about specific health conditions, visit the following sections:
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This Website last modified August 5, 2010.
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