SILICONE BREAST IMPLANTS
Breast implants are medical devices that are implanted under the breast tissue, chest wall muscle or breast skin and muscle. They are used to increase the size of breasts (breast augmentation) or to rebuild breast tissue after mastectomy or other defects during breast reconstruction. Silicone breast implants may also be used in revision surgery to correct or improve the result of previous surgery.
here are two types of breast implants approved for use, saline filled and silicone gel filled breast implants. Both types have a silicone outer shell. Today we mostly used silicone implants as we feel it provides an improved cosmetic appearance, durability and no possibility of spontaneous deflation.
More than 1.5 million American women currently have silicone breast implants. The majority of patients, (two thirds), had silicone implants to improve the appearance of their breasts via breast augmentation. The remaining one third of patient received implants for breast reconstruction either before (prophylactic) or after the development of breast cancer.
Today the safety of silicone breast implants are well accepted albeit a long controversial history. In January 1992 the United States Food and Drug Administration announced a voluntary moratorium on silicone gel-filled breast implants and banned the use of silicone implants in the United States for a period of 14 years. The concern was regarding the possible cause of connective tissue disease, chronic inflammatory disease and cancer. Multiple clinical trials and investigations lead to the suspension of the moratorium and the FDA announcing the safety of silicone breast implants.
During this time South African surgeons continued to use silicone implants. Review of South African statistics of implants used during this time did not reflect an increase in disease processes associated with silicone implants.
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants.
The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) develops in the fluid around the breast implant and is usually contained by the fibrous capsule around the implant, it does not develop in the breast tissue. The current risk is estimated to be 1 in 30 000 vs a risk of 1 in 8 of developing breast cancer. However documented cases of BIA-ALCL in smooth implants remains limited and some literature suggest it only occurs in textured implants. Because it is a rare disease it is difficult to be certain about the absolute risk of the disease.
THE MOST COMMON SYMPTOM IS A PERSISTENT SWELLING OF THE BREAST WITH OR WITHOUT AN ASSOCIATED BREAST LUMP. THESE SYMPTOMS DEVELOP BETWEEN 3 AND 14 YEARS POST INSERTION OF THE IMPLANT, MOST COMMONLY 8 YEARS POST-SURGERY.
The fluid is evaluated via ultrasound investigation and then sent for special tests. The majority of cases are cured with removal of the implant and associated capsule without the need of additional treatment. To date, there have been less than 400 cases worldwide with all of them having a 100% survival and cure rate.
All patients should be familiar with the potential complications associated with silicone prosthesis in order to make an informed decision.