August 2019 | Newsline

FDA Prompts Limited Breast Implant Recall

In response to the FDA’s analysis showing increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, they have requested that these devices be recalled.

BIA-ALCL is not breast cancer – it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant.

The latest worldwide report shows a total of 573 documented BIA-ALCL cases including 33 patient deaths. Of those cases, 481 are reported to have Allergan breast implants at the time of diagnosis.

At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, the diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated.

Currently, due to the low risk of developing BIA-ALCL, the FDA is not recommending surgical removal of these implants in patients who have no symptoms. However, any patients who notice changes such as persistent swelling or painful areas around their breast implants, should contact us regarding the need for further evaluation.

We will report any new information from the FDA in future issues of Update.

Textured vs. Smooth

At one time, we used textured implants because, theoretically, it was believed that the rough surface would reduce the risk of capsular contracture as well as prevent implant rotation. This did not prove to be the case and we abandoned the use of them many years ago and exclusively use smooth. The occasional problems we still see with those textured implants are mostly related to firmness and/or leakage.

Silicone vs. Saline

Dr. Tobin emphasizes that, at this point, all patients who have silicone gel-filled breast implantsare at risk of leakage. Since gel leakage does not always show up during routine mammograms, it can go undetected for years. For this reason, Dr. Tobin, along with most Cosmetic Surgeons, recommends that patients plan to have them replaced every 10 years.

We recommend patients who have silicone gel-filled implants come in for periodic examinations and stress that they contact us immediately if they notice any changes such as firmness, displacement or discomfort.

Saline-filled implants, on the other hand, do not need periodic replacement. These implants are filled with saline (saltwater). If they leak, the saline is quickly absorbed by the body and causes no harm to the patient.

We will have more to say about the pros and cons of saline versus silicone gel-filled implants in our upcoming issues of Update. As always, we welcome your feedback.


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