How Does FDA Approval Work for Breast Implants?

If you want to be a well informed patient, it’s important that you know all about the drugs that your physician is prescribing. And it’s the same with breast implants. If you are considering breast augmentation, you’ll want to know that any implant used in the procedure is safe.

One common way of checking if an implant is safe is by looking at whether it’s been approved by the FDA. Here, we’ll walk you through the approval of a recent implant, using Allergan’s Natrelle 410 Silicone-Filled Breast Implants as an example.

Getting FDA Approval For An Implant

Companies often make new products that they believe are safer, more effective improvements upon currently sold implants. But they have to demonstrate that their new implant is safe if they want to sell it.

The FDA requires hard data on the safety of new medical products. To get this data the company will fund clinical trials to prove that their new implant is safe. These studies can often involve thousands of patients, cost millions of dollars, and take over a decade.

Clinical Trial For Natrelle Implants

Allergan funded a large study that tracked over 700 women from 1999 to 2010 who had received the Natrelle implant. The researches divided the women into 4 groups, depending on the type of procedure they had:

• Primary reconstruction
• Primary augmentation
• Correction of past augmentation surgery
• Correction of past reconstruction surgery

After years of research, the trial showed that patients experienced very similar side effects to other implants, with one small exception. A small percentage of patients experienced cracks or fissures in the implant, which was not found in other implants. Other than this, there was no indication that the Natrelle implant was any less safe than other implant options.

Researches are very thorough in these trials, tracking just about every detail they can. With implants, researchers pay particular attention to rashes, swelling, and bruising that develop after the procedure.

One of the most important measures for the FDA to consider are the patient and doctor satisfaction ratings. In the Natrelle trial, patients and doctors reported an average satisfaction of 4.8 out of 5 after the trial. These are high ratings, something that the FDA takes into account when comparing the implant to other products.

FDA Considers The Evidence From The Trial

The FDA takes all of this detail into consideration when they make an approval decision. The FDA know that there will be side effects with just about every medical product. What they look for when approving a product is whether its benefits are worth its costs, and how its safety profile compares to existing products.

With all of their data on hand, the FDA will make a final decision on whether they should approve the products. Once they do decide to approve an implant, that doesn’t mean the FDA steps aside completely. To ensure that the product is still safe once , the FDA will require post-approval trials.

In the case of Natrelle, these trials involved:

• A 5 year study on 3,500 women
• Starting another trial that would track long term side effects in 10,000 women
• Funding 5 control studies to learn more about the link between silicone implants and rare diseases
• Analyzing any implants that are returned to the company

Trusting FDA Approval

As this example should make clear, the FDA is quite thorough whenever approving a new implant. And they continue to review implants, even after approval, so that you know that every product out there is safe.

Looking For The Right Implant

There are a lot of implants out there. As you and your physician search for the right implant for your breast augmentation, know that the implants you will be choosing from have all been researched with extensive trials. You can trust that the process to approve an implant is designed to protect your health.