The FDA has published millions of reports about problems with medical devices. The agency allows manufacturers to submit reports about problems with their products to its employees. These reports can also be accessed on MAUDE's database which is accessible to the public. Implant safety is affected differently by different factors. For example, a textured area can prevent rotation. A woman who smokes has a greater chance of complications from implants. Be sure to check your medical history for autoimmune diseases if you are considering breast implants.
Textured surfaces prevent rotation
Tough surfaces, however, will prevent the rotation of breast implants that are teardrop-shaped. The Velcro-like effect of textured surfaces prevents the implant from rotating. Likewise, round implants will not rotate as much, so they will be more secure in the breast pocket. Although rotation of teardrop-shaped implant can be a rare problem, it can still pose an aesthetic problem.
Avoiding autoimmune disorders
FDA is yet to determine if silicone breast implants can cause autoimmune diseases. Breast implants have been linked to arthritis-like conditions in some doctors. The FDA cannot prove that breast implants cause autoimmune disorders. However, evidence is mounting to support this possibility. The World Health Organization recently conducted a study that found a link between breast implant use and rare cancers.
Surgery can be reversed
Breast implants surgery is not possible to reverse, unlike other cosmetic surgeries like tummy tuck and rhinoplasty. Once the implants are in place, the shape of your breast will never return to its original shape. Implanted breast tissue can become dimpled or wrinkled. It is possible to feel significant pain following the procedure. However, you can minimize these risks by selecting a plastic surgeon who is trained in breast implant surgery.
Patient device cards
The latest updates to the FDA's guidelines on patient device cards for breast implants have made it more important than ever to provide patient information about the product. The latest guidelines recommend that patient device cards include information about the type of implant, its serial number, and any boxed warnings. To provide more information, patients should be directed to the device's label or decision checklist via web links.
Screening to detect rupture
The Food and Drug Administration recommends that breast implants be scanned every two to three years. Ultrasound is able to distinguish between normal and broken implants. Ultrasound will show normal implants as homogeneous and well-defined. Ruptured implants will have a snow-storm-like appearance. To determine the extent and cause of your rupture, schedule an MRI. This type if imaging is not covered by any health insurance.