The FDA has published many millions of reports regarding problems with medical equipment. It allows manufacturers to report problems with their products to the agency. The agency also makes the reports available online through MAUDE, which is free to the public. Several factors can affect implant safety. Rotation can be prevented by a textured surface. 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
While it is possible to rotate teardrop-shaped breast implants, textured surfaces will likely prevent this. The Velcro-like effect of textured surfaces prevents the implant from rotating. Round implants won't rotate nearly as much so they will stay in the breast pocket. While rotation of teardrop implant shapes is not a major problem, it can still cause aesthetic problems.
Avoiding autoimmune disorders
FDA has not yet concluded if silicone implants in breasts can be linked to autoimmune conditions. Some doctors have reported developing arthritis-like disorders after breast implants. Although the FDA is not able to prove a direct link between breast implants, and autoimmune diseases, there is growing evidence. A recent World Health Organization study found a connection between breast implants & rare cancers.
Irreversibility after surgery
Breast implant surgery cannot be reversed, unlike cosmetic procedures like tummy tuck or rhinoplasty. The shape of your breasts will not return to their original form once the implants have been placed. Implanted breast tissue could be dimpled, wrinkled or distorted. A significant amount of pain may result from the procedure. These risks can be minimized by choosing a breast surgeon who has been trained in the procedure.
Patient device cards
According to the FDA, the latest revisions to its guidelines for patient device cards for breast implant have made it even more important to give information to patients about the product. According to the latest FDA guidelines, patient device cards must include information about the implant type, serial number and any boxed warnings. In order to provide additional information about the product, the cards must include web links that link patients to the device label and decision list.
Examining for rupture
The Food and Drug Administration's (FDA) recommends periodic imaging for breast implants 2 to 3 years after surgery. Ultrasound can distinguish between normal implants and ruptured ones. On ultrasound, normal implants will look well-defined and homogeneous. Ruptured implants will have a snow-storm-like appearance. An MRI should be scheduled if you have any of these symptoms. This will allow you to determine the extent of the rupture. This type of imaging cannot be covered by insurance.