The pharmaceutical company Allergan announced on July 24 that it is voluntarily recalling breast implants with its Biocell textured surface. The implants have been linked to a rare cancer called breast implant-associated anaplastic large cell lymphoma. If you already have one of these implants, the U.S. Food and Drug Administration does not recommend having it removed unless you have symptoms of BIA-ALCL.
Background
The FDA first identified BIA-ALCL in 2011, but the connection between textured implants and lymphoma first gained national attention in 2017, when it was reported in a New York Times article. The FDA has been gathering information on the disease and in March held a public advisory committee meeting about the issue. Though there are conflicting data on the exact number of cases, the FDA counts 573 reported cases worldwide. It also finds that most of these cases – 481 reported so far – were connected to Allergan implants.
BIA-ALCL is not breast cancer. It is a form of lymphoma, a type of cancer found in the immune system. In most cases, BIA-ALCL is treated with surgery to remove the implant and the scar tissue that forms around it, called the scar capsule. If the cancer has traveled to the lymph nodes or to other nearby tissues, treatment may include chemotherapy and radiation therapy.
Steven E. Copit, MD, a clinical professor in the division of plastic surgery at Thomas Jefferson University, shares a few key points for those who are concerned about BIA-ALCL:
- BIA-ALCL is very rare, even in women with the implants included in this recall.
- The confirmed cases came only from textured implants.
- Most cases of BIA-ALCL have clear symptoms, usually swelling from a fluid buildup around the implant.
- In most cases, treating BIA-ALCL is surgery to remove the implant and the scar tissue around it, which is a common operation.
What breast implants are affected?
The recall is limited to Allergan products with the Biocell textured surface. Other brands of textured implants are not affected, and other Allergan implants — including all smooth implants and Microcell textured implants — continue to be available. The important feature for this recall is the textured surface; the recalled implants may be filled with either saline or silicone.
It’s not known how implants cause the disease, but the deeper texturing of the Allergan Biocell products shows a much stronger link to BIA-ALCL than other textured implants or smooth implants.
How do I know if my implant is one of those recalled?
The recall includes all Allergan implants with Biocell textured surface, whether the filling is saline or silicone. The FDA guidance for people with implants has a full list of products that were recalled. If you do not remember the surface type for your implant or the specific product name and do not have paperwork from your operation, call your plastic surgeon’s office. They should be able to provide that information.
What if I have a recalled implant?
The FDA does not recommend removing a breast implant that is already in place. The risk of developing BIA-ALCL is very low, even with the textured surface in these Allergan products. If you do develop BIA-ALCL, treatment is straightforward. In most cases, BIA-ALCL is treated with surgery similar to what would be used to remove the implant now. And, Dr. Copit notes, removing the implant now brings risks that come with any operation.
“If you reflexively remove them out of fear of a very rare disease, you are subjecting yourself, potentially, to less severe, but more common complications like capsular contracture, [and] the implants shifting or moving,” Dr. Copit says.
In the end, the decision to keep or remove the implant is yours. If you feel more comfortable without the textured implants, speak to your plastic surgeon about your concerns. It is reasonable to request a removal if you have heard all the information and are still not comfortable keeping the recalled implant, Dr. Copit says. Your plastic surgeon can remove the implant or replace it with one that has a smooth surface. If you choose to replace, Allergan says it will provide a smooth implant at no charge, but you will still be responsible for the cost of surgery.
For those who have textured implants and decide not to remove them, he recommends staying informed. Researchers and regulators are still learning about BIA-ALCL and there is likely to be more news as data comes in.
You should also watch for signs of BIA-ALCL, as they can, and usually do, appear years after you heal from surgery. Common symptoms include pain and swelling around the implant. Dr. Copit advises people to report any change in their implants to their plastic surgeon, no matter what the cause, to see if it is a sign of more serious complications.
What if I am considering implants?
If you are considering implants, your plastic surgeon should discuss BIA-ALCL with you. If they don’t bring it up, it is OK to ask. They should be prepared to discuss the risk of BIA-ALCL, the association with certain types of breast implants, and why they recommend a specific implant. They should not offer any Allergan Biocell textured implants.
Other textured implants, such as Allergan’s Microcell textured implants and textured implants from other companies, may still be available. But many plastic surgeons, including Dr. Copit, have stopped offering textured implants.
“If we knew the final answers, I probably would still use them. But this is still evolving and I think, for now, the safe, conservative thing to do is not offer them,” Dr. Copit says.
Textured implants work better for certain people and situations, which is why plastic surgeons recommended them in the past and why some may still. If your plastic surgeon offers a textured implant, they should discuss the risk of BIA-ALCL with you. If you are uncomfortable with getting a textured implant, it is OK to share your concerns and to ask for a smooth implant instead.
FDA Recommendations for People with Breast Implants
- The FDA does not recommend having implants removed if you do not have any symptoms for BIA-ALCL.
- Watch for symptoms of BIA-ALCL
- persistent pain or swelling near the breast implant
- changes in breast shape
- appearance begins to differ from other breast in shape, size, or level
- any lumps or collected fluid near the implant
- Tell your healthcare provider if you have any of these symptoms and suspect BIA-ALCL.
- People with confirmed BIA-ALCL should have the breast implant and the surrounding scar capsule removed.
- Keep a record of the manufacturer, unique device identifier, and implant model name for your implant. If you have an implant and don’t know this information, ask your surgeon or the center where you got the operation for records from your surgery.
- Be aware that most cases of BIA-ALCL happen years after surgery. Watch for symptoms, and talk to your plastic surgeon about your risk of developing BIA-ALCL if you have concerns.
- If you are considering getting a breast implant, read the FDA’s Things to Consider Before Getting Implants.
