The FDA published millions of reports about issues with medical devices. The FDA allows manufacturers and distributors to submit problems with their products for its employees. The agency also makes the reports available online through MAUDE, which is free to the public. Implant safety is affected by several factors. A textured surface may prevent rotation. Implant complications are more likely for women who smoke. You should check to see if your medical history includes autoimmune disorders if you are thinking about breast implants.
Textured surfaces prevent rotation
Although it is possible for breast implants of teardrop shape to be rotated, textured surfaces may prevent it. Because textured surfaces have a Velcro-like effect, they will prevent rotation of the implant. Round implants will not rotate so will be less secure in the breast. Though rotation of teardrop-shaped implants is a small risk, it can still be an aesthetic issue.
Avoiding autoimmune disorders
The FDA has yet to conclude whether or not silicone breast implants are linked to autoimmune diseases. 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 of surgery
Breast implants surgery is not possible to reverse, unlike other cosmetic surgeries like tummy tuck and rhinoplasty. After your implants are installed, your breast shape is permanent. Implanted breast tissue may be dimpled. 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
In light of the FDA's latest guidelines on patient devices cards for breast implants, it is more important than ever that patients are provided with information 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. Patients should be able to access additional information by using web links on the cards.
Screening for rupture
The Food and Drug Administration advises regular imaging of breast implants after two to three year. Ultrasound can differentiate between normal and ruptured implants. Normal implants will appear well-defined and homogeneous on ultrasound. A ruptured implant will look like a snowstorm. 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.