On July 24th, Allergan announced it was recalling its BIOCELL textured expanders and implants from the global market in response to a request from the FDA. The FDA made the request that Allergan recall all its BIOCELL textured breast implants and tissue expanders based on newly submitted Medical Device Reports reporting worldwide cases of Breast Implant Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL), and related deaths associated with these devices.
BIA-ALCL is a rare cancer of the immune system that develops in the scar tissue surrounding breast implants. Common symptoms include swelling, significant fluid accumulation around the implant, pain and/or lumps in the breast. When caught early, the cancer is curable by removing the breast implant and the surrounding scar tissue (known as a capsulectomy). Patients with advanced disease need more treatment in the form of chemotherapy and radiation.
To date, 573 cases of BIA-ALCL and 33 deaths have been confirmed worldwide. Additional cases have been reported but have not been confirmed. Of the 573 confirmed cases, 481 have been attributed directly to Allergan’s Biocell textured implants leading to a global recall of the devices.
The US recall comes after an official FDA hearing was held in March to evaluate textured breast implant safety. The FDA first reported the possible link between breast implants and anaplastic large cell lymphoma in 2011. All confirmed cases have been attributed to textured implants. While there have also been cases in women who had smooth implants, due to the lack of a comprehensive medical history and incomplete implant information in these patients, there have been no confirmed cases attributed solely to smooth implants.
Although the Allergan textured implants have been recalled, the FDA is not recommending preventative removal of these textured implants in women who don’t have any symptoms due to the very low risk of developing BIA-ALCL. The FDA does recommend patients be educated on the potential risks associated with textured implants as well as the signs and symptoms of any complications. Patients are encouraged to contact their plastic surgeons with any questions or concerns whatsoever about their implants.
Read the full FDA patient safety communication here.
The FDA has announced that breast implants have been linked to a certain type of non-Hodgkin’s lymphoma (cancer of the immune system) known as Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
About 450,000 breast implant procedures (cosmetic and reconstructive) are performed yearly in the US alone. So far, 626 cases and 17 deaths have been reported globally. As of September 30, 2018, the FDA had received a total of 660 medical device reports (MDRs) of BIA-ALCL, including 9 patients who died in the US. These numbers are being updated frequently as more cases are diagnosed. Published data on lifetime risk of developing this lymphoma from a breast implant varies widely, between 1 in 1,000 and 1 in 30,000. This risk may vary among different implant manufacturers. The risk is higher when the implants have a rougher surface (have “aggressive texturing”) than when they have less rough surface.
Two types of breast implants are used for cosmetic augmentation and breast reconstruction: smooth surfaced and textured. Textured surfaces were introduced to encourage tissue adherence to prevent implants rotating. Currently, all anatomic-shaped implants on the market are textured. Round implants are available as both smooth and textured devices.
Most studies report BIA-ALCL is exclusively associated with textured implants. There have been no confirmed cases developing in patients who have only had smooth implants. However, the FDA has not excluded this possibility. There is no doubt the highest risk is associated with the more aggressively textured devices and polyurethane implants.
Symptoms include a large fluid collection developing more than one year after receiving an implant, breast swelling, a breast mass or new onset of breast asymmetry.
“Patients with BIA-ALCL most often develop the disease within eight to ten years of having a textured breast implant placed,” says Dr Mark Clemens, a leading global authority on BIA-ALCL and expert contributor to the Breast Advocate App. “Some patients may have a lump in the breast or armpit. Some patients developed an overlying skin rash or hardening of the breast. Women who develop these symptoms should see their physician to be evaluated with a physical exam and may require further testing… Patients without symptoms do not need to be tested for BIA-ALCL.”
In terms of testing, Dr Clemens explains “patients may receive an ultrasound or a magnetic resonance imaging (MRI) of an enlarged breast to evaluate for fluid or lumps around the implant. If fluid or a mass is found, patients will require a needle biopsy to test for disease. A fine needle biopsy is performed in a clinic by their physician or by an interventional radiologist using ultrasound guidance. Needle biopsies do not require surgery. The biopsy draws fluid from around the implant. This fluid is then tested for CD30 immunohistochemistry (CD30 IHC) by a pathologist. This is the screening test for BIA-ALCL and may take a week for evaluation. CD30 IHC is a common test, can be performed in any hospital and pathology lab, and does not require a specialized center. Some community hospitals may send specimens to a larger academic hospital if the lab results are confusing, suspicious, or indeterminate. Testing for CD30 IHC is required to make a diagnosis or rule out BIA-ALCL and is covered by all health insurance programs because the test is an investigation of a possible cancer.” Fluid collections around a breast may happen without BIA-ALCL and are called seromas. Once BIA-ALCL has been ruled out, a physician can treat a seroma as they normally would.
Early diagnosis and appropriate, prompt treatment including excision of the implant capsule are associated with very high cure rates. Disease re-occurrence is rare after surgical removal for early disease. Some patients can develop metastatic disease, in which case chemotherapy either alone or in combination with immunotherapy, is recommended.
According to the FDA and American Society of Plastic Surgeons, in the absence of any symptoms, there is no need to remove textured implants due to the risk of developing BIA-ALCL at this time. However, patients who are unhappy with their implants do have other options. These include implant revision surgery, or replacement of the implant with the patient’s own tissue (fat grafting or flap surgery).