The FDA ensures breast implant safety

Posted by Monarch Plastic Surgery

Jul 18, 2014 9:30:00 AM

fda-and-breast-implant-safetyBreast augmentation is one of the most popular surgeries in the United States and is generally considered a safe practice. However, in the 1990s breast augmentation and silicone implants came under scrutiny for a number of eventually unfounded concerns. But, how was it determined that these concerns were unfounded? How is a breast implant, and by extension, breast augmentation safety ensured? In the United States, the Food and Drug Administration (FDA) is a significant factor in determining the safety of breast implants and breast augmentation.

Breast implants are regulated medical devices

It is important to understand that breast implants are medical devices, regardless of type, size, or reason for use. In the United States, the FDA has approved implants with a silicone outer shell and either saline or silicone gel filling. The FDA requires manufacturers — Allergan, Mentor, and Sientra — to conduct a number of tests and studies to prove that breast implants are safe for use just like any other medical device. Manufacturers must prove that breast implants are safe for their intended purposes. In addition, the FDA monitors manufacture, use, risks, and complaints associated with breast implants and periodically updates regulatory guidelines based on data collected during monitoring.

Monitoring breast implants for long-term safety

Breast implant manufacturers understand that long-term safety is critical for breast implants and patients, and as a result they work with the FDA to monitor implant safety long-term. This includes gathering data from patients and physicians, as well as conducting carefully planned post-approval studies. Post-approval studies are designed to answer questions that can only be addressed or studied once a product or device — in this case breast implants — is available to a wider pool of consumers or patients. By extension, the results of these studies, including information about the benefits, risks, and proper usage must be made available to patients to help them make informed decisions.

Breast implant manufacturers must provide monitoring and report results

The FDA requires breast implant manufacturers to provide long-term monitoring of implants and to report on the findings of such studies. This includes enrolling women in 10 year clinical studies and to provide continuous monitoring of breast implant performance. Breast implant manufacturers are also required to ensure that patient safety information regarding both benefits and risks of implants is available and updated regularly, and manufacturers are tasked with ensuring that this information makes its way to the patient’s hands. The FDA follows thousands of women through their plastic surgeons in order to monitor long-term safety and effectiveness of breast implants nationwide. By enrolling so many women in breast implant studies, the FDA has a broad base of patients with a variety of backgrounds -- allowing for more realistic data collection. The FDA is thus able to monitor statistical trends and compare earlier studies with emerging information to determine potential outcomes.

Additional FDA requirements for silicone breast implants

In addition to long-term studies and rigorous testing, the FDA also has two additional requirements in their initiative to monitor breast implants and ensure patient safety with regard to silicone breast implants. First, the FDA has initiated a program to track silicone breast implants and to make notifying women of updated safety information easier. Second, the FDA restricts surgeon access to silicone implants, requiring plastic surgeons to complete a certificate program before they may begin offering silicone implants.

All surgical procedures carry risk, no matter how safe or regulated

Although breast augmentation is one of the most popular plastic surgery procedures in the United States with a proven track record of safety, it is important that patients understand that breast augmentation is still a surgical procedure and thus has associated risks. Your surgeon will discuss both the benefits and risks of breast augmentation with you during your consultation, and will also openly address any additional concerns you may have.

To learn more about breast augmentation, please call Monarch Plastic Surgery today at (913) 663-3838 for our Leawood and Lansing offices or (816) 436-3262 for our Kansas City office. We look forward to meeting you.

Topics: Breast augmentation

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