Have You Registered Your Implants Yet?

Posted in News, Plastic Surgery breast reconstruction patient

You register your car and your new smartphone; your dog has a registration and your kids get birth certificates. Why not protect your other “babies” and register your breast implants?

It’s an idea whose time has come, according to the U.S. Food and Drug Administration (FDA), the government agency that protects the public health and regulates medical devices. In 2011, the agency teamed up with the American Society of Plastic Surgeons to begin work on a national database. As of the end of 2013, they were still working on the registry—but the service will be available soon, so let’s talk about what it is and why you may want to participate.

Why Register?
There are several compelling reasons to create a national breast implant registry. (A voluntary registry exists now, but putting implant information in the planned national registry would be required.)

  • Women forget the size and volume of their implants. Because FDA statistics show that 1 out of every 3 women have their implants replaced during their lives, it can be important to have specific information about their current implants when planning a revision surgery.
  • Requirements to keep medical records vary from state to state. While surgeons keep information on file, of course, there is no national standard on how long they must retain it. Some states have no requirements about retaining medical records at all!
  • Surgeons retire or relocate. Time marches on for everyone, and even if information about implants were still on file, medical records can be difficult to locate if a surgeon has closed up shop or moved to another state.

If a national implant registry were in place, a woman could always locate the important information about her implants, whether her surgeon still had her medical records or not. As of now, the U.S. requires breast implant manufacturers to imprint a serial number, the name of the maker, and size on each implant. After a breast augmentation, that information is in turn sent to the implant manufacturer for quality control and research purposes. The key to a national registry would be that the woman with the implants also has easy access to this information, not just the implant manufacturer.

Implant Registry Helps Ensure Safety
Meanwhile, in England, authorities are quickly putting together a mandatory database for implants in light of the faulty PIP (Poly Implant Prothese) implant scandal and subsequent scare in Europe and South America. Had such a system been in place at the time the story broke about these substandard implants—which contained potentially harmful industrial grade silicone instead of medical grade silicone—all the estimated 300,000 women who had them could have been notified immediately and had them replaced as soon as possible. Fortunately, the safety of breast implants is not in question here in the United States, as the FDA subjects all medical devices to rigorous tests before they are approved for use.

So while you don’t have to register your implants yet, it’s a good idea to keep what vital statistics you have about them in a safe place. File it away with all your important information—like your kids’ birth certificates!

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