No Spin Live Episode 74 – The Allergan BIOCELL® Implant Recall and ALCL

No Spin Live Episode 74 – The Allergan BIOCELL® Implant Recall and ALCL

Breast implant-associated ALCL is a very rare form of cancer that has been linked to textured breast implants. Despite the fact that it has received extensive media attention, there is still a lot of confusion among breast augmentation patients as to what, exactly, this means. The situation has recently gotten worse thanks to an announcement that Allergan has issued a voluntary recall of their BIOCELL® textured breast implant and tissue expanders. Dr. William P. Adams Jr. of Dallas talks with board ceritifed plastic surgeon Dr. Pat McGuire of St. Louis about what this all means for patients.

What is Breast Implant-Associated ALCL?

Breast implant-associated ALCL is a very rare form of large cell lymphoma that has been associated exclusively with textured implants. Plastic surgeons have known about this disease and have spent considerable time educating their breast augmentation patients about it. However, the recent announcement by Allergan that they are voluntarily recalling all of their BIOCELL® textured implants  has sent the media into a flurry of misinformation. “It’s been kind of a rough week for our patients,” explains Dr. McGuire.

Is BIA-ALCL on the Rise?

Allergan’s recall was voluntary and also unexpected. They did not warn their plastic surgeon clients that this was happening so the surgeons had no chance to get the information out to their patients before the story hit the media. “We’re not really sure what changed that caused the announcement,” says Dr. McGuire. However, the FDA had recently announced that there was an increase in the number of worldwide deaths from BIA-ALCL from 21 to 33. Surgeons have not yet seen the data on these 12 additional cases, but they were all reported in just the last month.

No Spin Live Exclusive - Allergan Recalls Biocell Textured Implants Associated with ALCL

Recall Does Not Necessarily Mean Replace

“I think what scared the patients the most is the term ‘recall’,” explains Dr. McGuire. If you get a notice that there has been a recall on your car, you have to take the car in and get the part replaced, but that is not the case here. The FDA made it clear that they are not recommending that women have their implants removed. This recall only means that any BIOCELL® textured breast implants that have not been sold and are sitting in doctor’s offices or on the shelves at hospitals or surgery centers must be returned to Allergan and no further BIOCELL® implants can be placed. “I think it was a good decision on Allergan’s part,” says Dr. McGuire. Until there is more information, it’s better to be safe and the highest risk implants for ALCL are the macro-textured, or high surface area, implants. BIOCELL® is one of these.

#1 Rule if You Have Textured Implants

Patients panicked when they read about this recall online and Dr. McGuire’s phone started ringing off the hook. “The first thing that I am telling my patients is don’t panic,” she explains. If you have textured implants, even if they are BIOCELL® implants, you do not need to have them removed if they are not causing you any issues. Patients need to take the time to decide whether the very low risk of developing BIA-ALCL is worth removing their implants. The disease is so rare that 99.9% of patients who have textured implants will not develop this illness.

Macro-textured implant.

How to Protect Yourself?

The first thing that any breast augmentation patient needs to do to protect herself is know what kind of implants you have. Dr. McGuire has received many calls from patients with smooth implants; there has never been a case of BIA-ALCL with a smooth implant.

Next, figure out when you last saw your plastic surgeon about your breast implants. Dr. McGuire likes to see her implant patients yearly unless there is a problem. The most prominent symptom of BIA-ALCL is obvious swelling in one or both of your breasts. Other symptoms to look out for include:

  • a lump in the breast
  • skin rash
  • pain

Bottom line, if there has been any change in your breast, see your surgeon. There are other issues that may be happening that are much less scary that BIA-ALCL, so it’s always the smart move to have them checked if there are any changes.

There are Risks with Implant Removal

Many patients don’t realize that there is always a risk involved in implant removal. It is surgery that requires anesthesia and this entails additional risk. In fact, you are at a higher risk of dying from anesthesia than from BIA-ALCL. Furthermore, everything needs to be put in context. The mainstream media is very alarmist and makes it sound as if BIA-ALCL is a death sentence coming for every woman with breast implants. It’s not. The disease is incredibly rare, but if you happen to be one of the unlucky few who develop ALCL, it is highly treatable.

In general, Dr. McGuire advises any patient who isn’t experiencing a problem with her textured implants to let things be. The exception is the patient who is just too worried. For them, the risks of implant removal surgery are probably worth the peace of mind.

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