Over the past few months, textured breast implants and BIA-ALCL have been in the news. On July 24, 2019 the FDA requested that the Allergan company voluntarily recall its Biocell textured implants.Because of this recall, you may receive information directly from Allergan. Our objective is to provide our patients with additional information and to explain what action, if any, is appropriate.
What is BIA-ALCL?
“Breast Implant Associated Anaplastic Large Cell Lymphoma”, (BIA-ALCL), is a rare form of lymphoma. It is not a cancer that develops in the breast. Instead, it is a type of lymphoma that develops within the capsule that forms naturally around the implant.
Why Just the Allergan BioCell Textured Implants and Expanders?
Some breast implants have a textured surface. The texturing of the Biocell implants and expanders is different from the texturing of other implants and has been associated with the highest risk of BIA-ALCL. It is important to know that there have been NO confirmed cases of BIA-ALCL associated with smooth implants so that’s why the recall has been made for textured implants and expanders only.
Is Allergan’s Recall like an Automotive Safety Recall?
No. There are several different types of FDA recalls. Unlike an automotive recall that seeks to replace the “recalled” part, this type of recall is simply a withdrawal of Biocell implants from future use. The term is a little confusing, but it is the term that the FDA chooses to use. The “recall”, in other words, is directed at Allergan, not at you, the patient, or at your implants.
Is Allergan Or The FDA Asking Me To Have My Implants or Expanders Removed?
No, just the opposite. The FDA specifically stated that it does not recommend removal or replacement of Allergan BioCell textured implants in patients who have no symptoms. If you have Allergan Biocell textured expanders, they will be removed at the specified time for your smooth implant exchange. Therefore, it is not recommended to prematurely remove them.
Why Did Allergan Withdraw Its BioCell Textured Implants?
Although there are manufacturers of textured implants other than Allergan, the FDA analysis found that the risk of a BIA-ALCL diagnosis with Allergan products is approximately six times higher than that of other types of texture. 84% of the 573 reported cases have been linked to Allergan BioCell textured products. The diagnosis of BIA-ALCL is rare; the best estimate is thought to be approximately 1:3,000, although some centers have reported higher incidences. Currently, Mentor and Sientra textured devices are not required by the FDA to be withdrawn.
How Serious Is BIA-ALCL?
When BIA-ALCL is detected and treated early it is usually curable. Of the 573 cases in the world, there have been 33 deaths. Deaths associated with BIA-ALCL are thought to have resulted from delayed diagnosis or inappropriate treatment. The single most important intervention to prevent advanced BIA-ALCL is regular monitoring and early detection.
What Symptoms Should I Be Looking For?
Unlike breast cancer, BIA-ALCL most commonly presents with swelling of one breast. Other less common symptoms include hardening of the breast, an unusually persistent rash or a palpable mass in the breast or armpit – all easily identified by you. If you have any of these symptoms, please call to schedule an appointment for an examination and if needed, further tests. An ultrasound can detect the presence of fluid, and if present, a small amount can be aspirated with a needle and tested. Should this be positive for tests called CD30 and ALK, a diagnosis of BIA-ALCL will be considered. If the tests are negative, the fluid collection is considered benign. Benign fluid collections, known as seromas, are not uncommon around breast implants so it is important to differentiate them from those associated with ALCL.
What If The Tests Confirm BIA-ALCL?
In most patients, BIA-ALCL is curable with surgery alone – removing the textured implants and the capsule. Consultations with other medical specialists may be recommended but in most cases there is no need for radiation or chemotherapy.
What If I Do Not Have Any Symptoms?
The FDA recommends that you do not remove your BioCell textured breast implants at this time. Should you develop any of the signs or symptoms mentioned above, you should make an appointment for evaluation. You are the patient, however, and you do have the option of removing your BioCell implants, with or without replacement with smooth implants.
What Will Surgery Cost?
We ask that you come in for an evaluation and discussion to determine the potential surgical cost. In general, there may be some costs related to the operating room, anesthesia and surgeon fees for having your BioCell textured implants removed and for any additional surgery you may select, such as a breast lift or fat transfer. In some cosmetic and reconstruction cases, Allergan will provide the smooth implants without charge if you desire to have the implants exchanged. For reconstruction cases, if the insurance pays for the implant the warranty payment is not valid. This warranty at this time is limited to surgeries performed in the next two years or until July 24, 2021.
Why Did The Practice Not Contact Me?
We were made aware of Allergan’s decision to remove the textured devices as soon as it was released to the media. Each implant and expander that was placed into a patient is submitted via a device tracking system to Allergan. Per all medial devices placed into patients, the manufacturer holds the responsibility in submitting the notification to each patient.
Where Can I Find More To Read?
Additional information on ALCL and Allergan’s recall can be found here:
- FDA letter 5/3/2019 Summarizing recent FDA committee findings and recommendations
- FDA Reports of Breast Implant Associated Anaplastic Large Cell Lymphoma
- FDA Safety Communication to Patients 7/24/2019
- Allergan’s Letter to Consumers 8/9/2019
- Allergan’s Implant Warranty
If you have further concerns and would like to meet with your doctor, please contact our office to schedule an appointment. We can be reached at 919-785-0505 or you can email us at: [email protected]