Allergan’s recent recall announcement for their BIOCELL textured breast implant products has led to more questions from confused patients grappling to understand what the recall means and whether it applies to their implants. With the recall, the Food and Drug Administration (FDA) released new data stating there have been 573 cases globally of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of non-Hodgkin’s lymphoma, and 33 patient deaths from the disease. Last week’s statement from the FDA read: “Specifically, of the 573 unique cases of BIA-ALCL, 481 are attributed to Allergan implants. Of the 33 patient deaths the FDA is reporting today, 12 of the 13 patients for which the manufacturer of the implant is known, are confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis.”
NewBeauty reached out to the top aesthetic plastic surgeons at the forefront of this issue to help dispel misinformation and assumptions about the recalled implants and patient risks for acquiring BIA-ALCL. All the doctors we spoke to have been closely involved and have a similar message: Don’t panic!
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1. The recall is not for Allergan BIOCELL implants that have already been placed.
“The term ‘recall’ is confusing for patients, this is not like an automotive recall. Allergan recalled unsold, textured-surface implants and tissue expanders worldwide that have not been implanted yet. Patients are advised to monitor their breasts for the unlikely event of one-sided swelling that may be fluid accumulation (late-term seroma) and to have it evaluated. Patients should be seen periodically by their plastic surgeon and of course, have diagnostic mammograms per their doctor’s recommendations.” —Eugene, OR plastic surgeon Mark Jewell, MD
“The confusing part is that the term ‘recall’ means something different to the public than what it means here. What Allergan is essentially saying is that this one type of textured implant, the macro-textured, is being recalled only if it has been shipped to doctor’s offices, or if they’re currently in stock in the office. Those are the only implants being called back. The FDA has also contended if patients have these implants and are not having a problem, there is no need to remove them at this time.” —La Jolla, CA plastic surgeon Robert Singer, MD
“Just to be clear, the FDA did not recall the BIOCELL textured implants. This was a voluntary recall by Allergan to remove them from the market. After the FDA hearings in March, they did not feel there was a reason to take action at that time and kept all implants, including the textured ones, on the market in the United States. Some international governmental agencies had already placed restrictions on the BIOCELL implant prior to Allergan’s announcement.” —Louisville, KY plastic surgeon M. Bradley Calobrace, MD
2. Not all textured implants have been recalled.
“As we learn more and more about BIA-ALCL, we’ve discovered that the more textured implants have had a higher incidence of disease. Implants that have a higher textured surface area—the best colloquial term to describe it is macro-textures—by far have had many more cases of ALCS and the FDA had been following that, along with Allergan, and that’s what led them to pull them off the market. But it’s important to note that the implant is basically like a passenger in this whole process, basically a carrier for bacteria. With the more textured implants, there are exponentially higher numbers of bacteria on the implant surface. That’s why we see more cases with the macrotexture implants compared to the less-textured implants. I think there’s a misconception that the implants are causing this illness. The implants are associated with it, but not necessarily causing it. Really, the best way to explain it is that the bacteria that causes the chronic inflammation is basically living in all the little nooks and crannies of the macro-textured implants.” —Dallas plastic surgeon William P. Adams, MD
“The vast majority of cases of BIA-ALCL in the U.S. and around the world are associated with the BIOCELL textured implants. All textured implants have had some cases of variable degrees, but the BIOCELL texture probably represents 90 percent or more of all of the cases. Whereas the risk of getting BIA-ALCL with BIOCELL may be estimated at around 1:3,200 or maybe even more in some studies, the risk with a less aggressively textured implant such as a Mentor Siltex implant would be around 1:82,000 or even much less for some other textures.” —Dr. Calobrace
3. You can find out the exact type of implant you have if you don’t already know.
“Patients can check the implant card that they were given after their implants were placed. It will say the manufacturer’s name as well as an implant identifier. That can be cross-referenced with industry websites to confirm whether they are smooth or textured, or they can call their plastic surgeon’s office. The office can interpret information on the card or help look up the patient’s implant information.” —Nashville, TN plastic surgeon Melinda Haws, MD
“Patients are given a card with their implant information on it. However, their surgeon should have those records. We’ve had 20 or more patients call yesterday asking what type of implant they have. There is absolutely no reason for patients to panic. A visit to their plastic surgeon would be a great way to start. Their surgeon can let them know the type of implant they have and how to move forward.” —Dr. Calobrace
“If a patient cannot find which type of implant they have, a screening diagnostic ultrasound can be used to identify implant surface if it is not known. Textured-surface implants look ‘fuzzy.’” —Dr. Jewell
4. BIA-ALCL is not breast cancer.
“It is technically not a breast cancer, but a lymphoma of the scar tissue around the implant and usually starts in a fluid collection around the implant. It can also present as a lump in the breast or under the arm. The fluid collection is typically very noticeable and causes a significant change in the size of the breast. While not all fluid collections are ALCL, they all should be evaluated. Any change in the look or feel of your breast should trigger a visit to your plastic surgeon. ALCL, if caught early, is highly treatable by surgery alone.” —Dr. Haws
“BIA-ACLC is rather to easy to diagnose—a simple sampling of the collected fluid will determine if this could be lymphoma. It is possible to develop it without the fluid collection, so further studies are necessary in some patients. Remember, we are trying to monitor patients for early diagnosis of breast cancer, also. The risk of breast cancer is 1 in 8 women, while 1:3,200 to 1:80,000 or less get BIA-ALCL with a textured implant and basically none with a smooth implant. In the U.S., 90 percent or more of implants used over the past 20 years have been smooth, so most patients with implants are at no risk of BIA-ALCL. But, they still have a 1:8 risk of breast cancer even without implants. Women need to do self-breast exams and have ongoing follow up visits with their plastic surgeons, who should be certified by the American Board of Plastic Surgery to catch breast cancer and this type of lymphoma early.” —Dr. Calobrace
“Board-certified plastic surgeons are primarily concerned about the safety and well-being of their patients and are there to answer the questions and address the concerns of patients. Any development of BIA-ACL is a significant concern. It is important to put this in perspective that there is a total of 537 unique cases of documented BIA-ALCL in the estimated 20,000,000 to 35,000,000 women with implants around the world.” —Dr. Singer
5. It is not necessary to have BIOCELL implants removed or replaced if there are no signs or symptoms of BIA-ALCL.
“Even for those patients with BIOCELL textured implants, this is not a recall to have their implants removed. This is a recall on the further sale of these implants. Revision surgery is a big surgery and ALCL is too rare to have patients take out their implants and capsules. It is always a patient’s right and choice to do so, of course, but only after discussion with their surgeon and thoughtful consideration as to the risks and benefits of such a course of action. In general, patients should be monitored annually or so to ensure early detection for that rare occurrence.” —Dr. Calobrace
“There is no recommendation from the FDA that patients who currently have BIOCELL implants to have them removed. At this time, they want patients to be aware of their risk of ALCL and follow up with their doctor at any sign of change in the implanted breasts.” —Dr. Haws
6. Allergan will offer patients who have textured implants the opportunity to receive a set of smooth round implants.
The company has just announced their decision to offer patients a set of new implants to replace the textured implants if they choose or need to have their BIOCELL implants replaced, but will not cover surgical fees. A letter from Allergan senior vice president, U.S. Medical Aesthetics Carrie Strom to plastic surgery patients states:
“For patients in the U.S. who, as a result of the recall announcement on July 24, 2019, choose to replace their BIOCELL textured devices with smooth devices in consultation with their plastic surgeon, Allergan will provide Allergan smooth device replacements for free. The program will run for 24 months, until July 24, 2021, and will apply to revision surgeries on or after the date of the recall announcement, July 24, 2019.
The decision to get a breast implant revision is a personal decision between patients and their plastic surgeons, and must be decided based on the appropriate discussion of benefits and risks. As part of this program, Allergan will not provide surgical fee assistance to revision patients. This decision is in-line with the FDA’s recommendation not to remove textured implants.”
7. A consultation with your board-certified plastic surgeon is the best course of action if you have any questions or concerns about your implants or BIA-ALCL.
“If patients are having problems or simply want to remove or exchange implants, it is important for them to know that smooth implants have not been linked to BIA-ALCL and this is a textured implant problem—mostly a BIOCELL textured implant problem. Although the FDA reports there have been some smooth implant cases reported, of all the cases we can confirm through ongoing databases and from all three U.S. manufacturers, a smooth case of BIA-ALCL cannot be confirmed. Smooth implants are a very safe alternative.” —Dr. Calobrace
“The most common presentation of ALCL is an enlargement of the breast. The vast majority of people that have a seroma don’t have ALCL, but your plastic surgeon would want to know if something changes. If your breast becomes larger, if it becomes firmer or if you feel something in the breast, you need to go see your board-certified plastic surgeon. It’s a very simple evaluation to test it, and then you can be counseled appropriately. I think the other thing is if you are uneasy about your implant, then go see your board-certified plastic surgeon, or find a board-certified plastic surgeon for a consultation to discuss your options.” —Dr. Adams
“In talking with my own patients, I want them to have all the facts to make their own decision. Breast implants are an elective, not a life-saving device. Each patient should be given all the information to make the decisions that work for her. I personally have BIOCELL implants in place. I recently had them scanned with a high-resolution ultrasound device which showed them to be intact. I have had no change in the look or feel of my BIOCELL implants, so I am not going to change them out until I am ready to change size or upgrade the implants, because there are risks to surgery as well. I know what to watch for in my own breasts and know my risk of breast cancer is much higher. Each woman gets to make her own decision with all the facts specific to her, just like I do, and I hope I can help be part of that discussion.” —Dr. Haws