Medical Devices

Implants and Prosthetics

Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or provide support to organs and tissues.

Some implants are made from skin, bone or other body tissues.  Others are made from metal, plastic, ceramic or other materials.

Implants can be placed permanently or they can be removed once they are no longer needed. For example, stents or hip implants are intended to be permanent.  But chemotherapy ports or screws to repair broken bones can be removed when they no longer needed.

The risks of medical implants include surgical risks during placement or removal, infection, and implant failure.  Some people also have reactions to the materials used in implants.

All surgical procedures have risks. These include bruising at the surgical site, pain, swelling and redness. When your implant is inserted or removed, you should expect these types of complications.

Infections are common.  Most come from skin contamination at the time of surgery. If you get an infection, you may need to have a drain inserted near the implant, take medication, or even have the implant removed.

Over time, your implant could move, break, or stop working properly.  If this happens, you may require additional surgery to repair or replace the implant.

If you learn that you need a medical implant, you should ask your doctor the following questions before agreeing to the procedure:

  • Will my implant be permanent or removable? If the device is permanent, find out how long it should last. If the device is removable, find out how long it will be implanted in you and what factors will determine when it can come out.
  • What material will the implant be made from? Make sure you are not allergic to any of the components in the implant.
  • How many of these procedures have you done? The more experience a doctor has with inserting implants, the better the outcome may be.
  • What are the complication rates from the procedure? Make sure you understand the risks of the surgery, infection, and device failure.
  • What are the benefits of the procedure? Make sure you understand how the device will benefit you and if it will affect your quality of life.

 

Approvals & Clearances

Contact FDA

1-800-638-2041
301-796-7100
Fax:301-847-8149
CDRH-Division of Industry and Consumer Education (DICE)(formerly DSMICA)

Office of Communication and Education

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

WO66-4621

Silver Spring, MD 20993

Page Last Updated: 06/06/2014
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