Breast implants details and guidelines

Breast implants are FDA-approved medical devices that are implanted under the breast tissue or the chest muscle to increase breast proportion or size, which is known as augmentation, or to rebuild breast tissue after mastectomy or other damage to the breast, which is known as reconstruction.

Implants have also been approved to correct the result of a previous surgery, which is referred to as a revision surgery.

Two types of breast implants have been FDA-approved: saline (salt-water solution)-filled and silicone gel-filled. Both of the implant types have a silicone outer shell and vary in size, thickness and shape.

Silicone implants sold in the U.S. undergo strict medical testing. However, there are some risks associated with all breast implants, including:

additional surgeries;
capsular contracture: scar tissue that squeezes the implant;
breast pain;
rupture; and
silent rupture of silicone-filled implants

Breast implants do not last a lifetime, according to the FDA. The longer the devices are implanted, the more likely complications are to arise — some of which will require the patient to undergo additional surgery.

Potential patients should research the available products and learn about their characteristics, as well as the fillers used. The FDA recommends reviewing the Summary of Safety and Effectiveness Data (SSED) on each implant, in addition to communicating with the surgeon by asking questions on his or her professional experience and past surgical procedures.

To achieve optimal results after the first procedure, careful planning and reasonable expectations are necessary.

Women are also encouraged to learn about long-term risks. Some women experience connective tissue diseases, lactation difficulties or reproductive problems. However, current evidence does not support an association between breast implants and these conditions, according to the FDA.

Women who choose silicone implants are encouraged to get MRI screenings to detect silent ruptures 3 years after the surgery and every 2 years thereafter.

References:

Fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants.

Fda.gov/ForConsumers/ConsumerUpdates/ucm338144.htm.