Textured Implant Recall

As widely reported in the media, Allergan has issued a voluntary recall of its line of textured shell implants and tissue expanders. The implants Allergan recalled are from the BIOCELL line, including Natrelle silicone, saline, and anatomically shaped implants, as well as Natrelle tissue expanders.

Why were Allergan breast implants recalled?

The reason behind the recall is related to a small increase in cases of BIA-ALCL, (breast implant associated anaplastic large cell lymphoma), a rare immune system cancer that develops around the scar tissue capsule – not in the breast tissue itself. This is not the cancer that is typically referred to as “breast cancer,” which is a cancer of the glandular tissue.

Implant replacement – should I?

It is important that you are aware that the number of cases of BIA-ALCL is low, and if you are not experiencing any symptoms and your breasts feel and look fine, the FDA does not advise you to have the implants removed and replaced.

What does the textured implant recall mean for me?

While this news may be alarming if you have textured implants, the FDA reports that the incidence of BIA-ALCL is relatively low, estimated to be in the range of 1 in 30,000. If you have concerns about BIA-ALCL, Dr. Reinblatt will be happy to meet with you and discuss your options. Generally, if you are not experiencing symptoms, there is no reason to have the implants removed and replaced. If you choose to do so, for your own peace of mind, Dr. Reinblatt will be happy to discuss this option with you.

Allergan and the breast implant recall

Allergan voluntarily recalled its line of textured implants worldwide and is providing free implant replacements for the next 24 months to those who have the Natrelle line of implants or tissue expanders. Textured implants can be replaced with smooth shell implants, which are not in any way associated with BIA-ALCL.

What to watch for: What are the symptoms of BIA-ALCL?

The symptoms associated with BIA-ALCL include:

  • Excessive fluid buildup around implants
  • Pain and swelling
  • Lumps in breast or armpit
  • Breasts appear asymmetrical
  • Hardened breast
  • Swollen breast
  • Skin rash

The good news is that the cancer is very treatable in the early stages. The cases of BIA-ALCL occurred years after the implants were placed, typically between 3 and 14 years after undergoing breast augmentation. If you have any concerns or have noticed any changes in your breasts, you can be tested with PET/CT testing. If the PET/CT scan reveals fluid buildup, a tiny amount of the fluid will be extracted by needle and sent to see if the fluid has the markers of the disease. Mammogram testing is not useful in identifying BIA-ALCL.

Is BIA-ALCL treatable?

Initially, BIA-ALCL develops in the fluid surrounding the implant. The disease is generally extremely treatable and curable in this stage, simply by removing the implant and the scar tissue capsule. The body naturally develops a scar tissue capsule around all implants, including smooth shell versions. As with any medical device, it is important to be aware of changes, whether your implants are smooth or textured. Dr. Reinblatt likes to see her patients yearly to ensure all is well.

Should I have my textured implants replaced?

Dr. Maura Reinblatt is a double board-certified plastic and general surgeon, educated at Harvard and UCLA, and a former faculty member at Johns Hopkins and Mt. Sinai. If you have concerns about your implants, she is very qualified to evaluate your breasts and discuss your options with you.

Some women may prefer to have their implants replaced, even if they are not experiencing any of the symptoms of BIA-ALCL, for their own peace of mind. These decisions are very personal. Dr. Reinblatt, as a female plastic surgeon, is focused on health issues specifically affecting women. She can provide you with information and guidance regarding the Allergan textured implant recall, your options, and what to do next.

Why do some women develop BIA-ALCL?

The rate of BIA-ALCL in women with textured implants is very low, and further research is needed to explain why certain women develop the disease, and further research is needed. It is theorized that it may be related to a genetic issue or to ongoing inflammation. Until the research is completed, the cause of BIA-ALCL is not fully understood.

Your health matters to us.

Dr. Maura Reinblatt is ready to assist you and discuss the Allergan textured implant recall with you. If you decide to have your implants replaced, or have any concerns, please contact us.

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