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Breast Implants and FDA Approval: How Does It Work?

Breast Implants and FDA Approval: How Does It Work?

Part of being a well-informed patient is knowing the what, why, and when of whatever medicine your doctor prescribes. Breast implants are no different, and we all want to be positive that whatever medical treatment, device or implant we use is safe.

Let’s take a look at the FDA’s approval process; to make it simple, we’ll use an example of a recent 2013 implant approval. Get ready, because it’s a mouthful — Allergan’s Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants.

To start, a company (Allergan) develops a new product they believe to be both safer and superior to implants already available. But, they must prove that implant is safe before they are allowed to sell them. To do so, the implant’s developer typically sponsors a clinical trial.

The FDA doesn’t just take a look at the technical specs of brand-new implants or take Allergan’s word for it—they have to see hard data backed by extensive research first.

The study — which collected data from 1999 to 2010—followed a total of 715 women to closely monitor their health and well-being after receiving the Natrelle implants.

Those 715 women were first split up into 4 distinct groups based on their exact type of surgery:

  • Primary augmentation;
  • Primary reconstruction;
  • Revision-augmentation (an augmentation to correct mistakes from a previous surgery);
  • And revision-reconstruction.

Researchers found that side effects of the Natrelle implants were generally identical to those of other available implants, with one exception—a very small number of the participants’ implants formed cracks or fissures, which is a problem unique to Allergan’s product.

These clinical trials are extremely detailed, keeping track of everything the FDA might find important. Of the common problems associated with most implants, the research indicates down to exact numbers just how many women experienced rashes, bruising or swelling. Every bit of data goes into the FDA evaluation.

Of course, no medical procedure or drug is 100% safe or effective for every person. The FDA’s job is to weigh the potential drawbacks of a new device or drug against its benefits.

Perhaps most relevant to potential augmentation recipients like yourself are the final patient and physician satisfaction ratings conducted at the end of the trial. For example, the hundreds of women who underwent a primary augmentation with Allergan’s implants gave Natrelle an average score of 4.8 out of 5—and so did their doctors.

Once the heaps of data are in, the FDA conducts a panel where they decide whether to approve the implants. Because many thousands of women will likely receive implants, the FDA also requires their developer to conduct post-approval studies (yes, more than one) to ensure their safety.

For Allergan, those conditions include:

  • Beginning a 5-year study on an additional 3,500 women;
  • Conducting a separate 10-year study on 2,000 women to examine possible long-term complications;
  • Developing 5 control studies to examine possible links between silicone implants and rare diseases;
  • And thoroughly analyzing any implants that are returned to the manufacturer.

As you can see, the FDA isn’t just pounding an “APPROVED” stamp on every trial that comes through their door. Their extensive review process extends to every type and manufacturer of implants—old, new, or still in development.

While their might be a specific kind of implant that’s perfect for you, it’s important to remember that all of the types currently available have been thoroughly researched and approved with your health and safety in mind.

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