The FDA has published millions upon millions of reports about medical device problems. The FDA allows manufacturers to submit complaints about 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 by several factors. For example, a textured area can prevent rotation. Smoking can increase the risk of implant complications. If you're considering breast implants, be sure to find out whether your medical history includes autoimmune diseases.
Textured surfaces prevent rotation
While it is possible to rotate teardrop-shaped breast implants, textured surfaces will likely prevent this. Because textured surfaces have a Velcro-like effect, they will prevent rotation of the implant. Round implants won't rotate as much and will therefore be more secure in breast pockets. Rotation of teardrop-shaped implants can pose a minor risk but it can be problematic for aesthetic reasons.
Avoiding autoimmune disorders
The FDA has yet to conclude whether or not silicone breast implants are linked to autoimmune diseases. Breast implants may have led to arthritis-like symptoms in some doctors. Although the FDA is not able to prove a direct link between breast implants, and autoimmune diseases, there is growing evidence. A recent study by the World Health Organization revealed a link between breast implants, rare cancers, and breast implants.
Irreversibility of surgery
Unlike cosmetic surgeries such as rhinoplasty or tummy tuck, breast implant surgery is not reversible. After the implants are placed, your breast shape will not be restored to its original state. Implanted breast tissue may be dimpled. The procedure may also cause you to experience a significant amount of pain. A breast implant surgeon can help you minimize the risks.
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. According to the latest FDA guidelines, patient device cards must include information about the implant type, serial number and any boxed warnings. Additionally, the cards should contain web links that direct patients to the device's label and decision checklist, so that they can access more information about the product.
Screening for rupture
The Food and Drug Administration (FDA) recommends periodic imaging of breast implants two to three years after surgery. Ultrasound can distinguish between normal implants and ruptured ones. Normal implants will appear well-defined and homogeneous on ultrasound. 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 if imaging is not covered by any health insurance.