Allergan Textured Implants and Cancer

On March 21, 2017, the U.S. FDA made a safety announcement about a link between textured breast implants and a very rare form of cancer: anaplastic large-cell lymphoma. In the announcement, the FDA called the cancer “breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).

Since then, the ante has been upped. On May 28 of last year, Health Canada suspended the sale of Allergan Biocell breast implants. In July, the U.S. FDA followed suit with a ban, requesting Allergan to recall all Biocell textured implants.

Dr. Kearney hasn’t been placing Biocell textured implants, but we’ve had patients inquiring about what’s going on. To answer that, here’s more information on the recall and ban.

What the FDA said

The FDA requested that Allergan recall all Biocell textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system. Based on the currently available information, the FDA’s analysis demonstrated that the risk of BIA-ALCL with Allergan Biocell textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers in the U.S. That’s why the FDA instructed Allergan to stop distribution.

The suspension means that Allergan is no longer allowed to sell its Biocell macro-textured implants in the U.S., and all unused implants are to be sent back to the manufacturer.

There is no recommendation for women to remove textured implants, as the number of cases is exceedingly low. Still, women who have received Allergan Biocell macro-textured implants should be on the lookout for any signs such as swelling, lumps, and pain in the breast.

What is ALCL?

ALCL is an uncommon cancer that can develop in any part of the body, most commonly the lymph nodes and skin. Research suggests that BIA-ALCL is usually found near the breast implant within the surrounding scar tissue, not in the breast itself. The lifetime risk for developing BIA-ALCL from a textured implant is estimated to be from one in 4,000 to one in 30,000. At this point, the type of implant (silicone or saline) doesn’t seem make a difference. It is the implant texture.

How is BIA-ALCL treated?

This is still a very rare risk. Plus, when BIA-ALCL is caught early it is usually curable. Treatment involved surgical removal of the implants and the scar tissue capsule, as the lymphoma appears almost always to be only in the scar tissue capsule.

Do you have questions about breast implants? Please call Dr. Kearney’s office at (858) 677-9352 and we’ll answer all of your questions.

Comments are closed.

After careful consideration and at the request of our state, and concern for the health and safety of our patients, we are cancelling all non-essential appointments and surgical procedures starting on 3-20-20. Please take note below of the ways that we are available to you over the next couple of weeks:

  • Appointments:Dr. Kearney will still be seeing a small number of post operative appointments over the next couple of weeks as well as any patients that require immediate attention or medical care, by appointment only. We are calling and emailing all patients who currently have appointments scheduled in the next 2 weeks to notify them and reschedule
  • Phone: We will be working remotely and able to answer questions as well as schedule future appointments and surgeries by calling our main number: 858.677.9352. Please note, however, that we will have reduced hours over the next couple of weeks so be sure to call during these times: M-F 9:30 a.m. to 3:30 p.m. If you have an urgent matter outside of these hours and need to speak to Dr. Kearney please call 619-270-4935.
  • Answering machine: Please do NOT leave important messages on the after hours greeting during the next 2 weeks as they may not be checked in a timely manner. Instead, we ask you to call or email during the above hours and we will get back to you as soon as possible.
  • Email: We will have access to email and our patient scheduling system and will be available to check and respond to emails M-F from 9:30 a.m. to 3:30 p.m. If you reach us outside of these hours please allow 24-48 hours for a response. You can continue to email the patient coordinator you’ve been in contact with or simply use [email protected]
  • Virtual consultations: Can’t come in for an appointment right now? No problem! Dr. Kearney is able to offer phone consultations during the next couple of weeks. Simply email us at [email protected] or call 858-677-9352 during the above hours and we will let you know the simple steps to take.

We apologize for any inconvenience the above changes may cause and are hoping things return to “normal” as soon as possible. Please stay safe and healthy and let’s all try to remain as positive as possible during this time of uncertainty.

We appreciate all of you and look forward to seeing you again very soon!

Sincerely,

Dr. Kearney and staff

858.677.9352

www.kearneymd.com