Ruptured Silicone Breast Implants
Silicone gel breast implants were first marketed in the United States in 1962. The FDA began regulating these medical devices in 1976. In 1992, however, the FDA restricted the use of silicone gel implants, except for patients requiring revision or mastectomy surgery. At that time, saline implants became the primary prosthesis for breast augmentation, replacing silicone implants until 2006.
When a silicone breast implant ruptures, it usually does not deflate, and it may go unnoticed. The filler gel leaks slowly out of the implant over time and spreads through the implant pocket. It begins intracapsular, becomes extracapsular, and then migrates throughout the chest and lymphatic tissue throughout the body. Implants can rupture as a result of:
- Damage during the original implantation or other surgery
- Blunt trauma to the chest
- Chemical degradation of the implant shell
- Mechanical pressure on the breast, including mammograms and ultrasounds
- Crease cracks in the implant
- Wear over time
Symptoms of Ruptured Silicone Implants
Some patients may be asymptomatic, and accurate results may be found using diagnostic radiograph, including MRI. Patients will often develop silicone mastitis and calcified granulomas due to ruptured silicone implant material once it becomes extracapsular. An MRI can determine whether the rupture is intracapsular or extracapsular. It is recommended for patients to consult with their board-certified plastic and reconstructive surgeon for evaluation as well as undergo diagnostic MRI testing to determine the integrity of their implants. Patients may have a ruptured silicone implant if they experience the following symptoms:
- Hardened breasts or capsular contracture
- Loss of upper pole fullness of one breast
Diagnosis of Silicone Implant Rupture
Studies show that the risk of implant rupture increases over time and that silicone gel implants are not lifetime devices. The imaging tests that can be used to determine a ruptured silicone gel breast implant include mammogram, CT scan, ultrasound, and MRI. A pathologist should rule out any possibility of breast cancer.
Patients are advised to undergo annual mammograms after the age of 35. When a mammogram has diagnosed an implant rupture, a patient may not require further imaging studies before surgical intervention. However, mammography has been known to produce false/negative readings, so a patient who receives a negative result may actually have a ruptured silicone implant. Due to the limitations of mammogram and ultrasound, in November 2006, the FDA recommended that patients have an MRI performed every three years to assess their implants for abnormalities. CT scans are not ideal because they involve ionized radiation and have not been studied to the extent that the MRIs have.
When an implant has been found to be ruptured, I believe the implant and implant material should be removed, and an open capsulectomy should be performed to remove all capsule scar tissue and calcified granulomas.