According to a recent report from the U.S. Food and Drug Administration (FDA), squamous cell carcinoma (SCC) and various lymphomas may develop in the capsule that forms around breast implants. The lymphomas are not the same as the breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) that prompted previous FDA announcements. The FDA learned about the newly associated cancer during a post-market review of breast implants.
It is very important to know that these cancers are extremely rare. Less than 20 cases of SCC and fewer than 30 cases of lymphoma were found in the capsule around a breast implant.
“After an initial extensive review, we currently believe that the risk [for squamous cell carcinoma] and other lymphomas occurring in the tissue around breast implants is rare,” said Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health. “However, in this case, and when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible.”
The type of implant appears to be irrelevant – all types of implants (smooth, textured, saline, and silicone) have been linked to SCC and lymphomas in the scar capsule around the implants. In some cases, women were diagnosed years after the placement of their implants. Some signs and symptoms include swelling, pain, lumps, or skin changes.
If you are considering breast implants or currently have them, the FDA recommends the following:
If you are a healthcare professional caring for patients with breast implants, the FDA recommends you:
The FDA said their consumer and healthcare recommendations don’t affect the previously provided suggestions on BIA-ALCL. They are continuously assessing the post-market safety of approved breast implants and will communicate any findings as soon as new information is available.
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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.
New safety concerns over breast implants has prompted the FDA to hold a two-day meeting to hear from researchers, patients, plastic surgeons, and implant manufacturers. The hearing was scheduled for March 25th and 26th, 2019.
Concerns surfaced recently following the publication of the first study to review breast implant safety data following the FDA’s approval of silicone implants. The study, published in Annals of Surgery, is the largest ever study of silicone breast implants.
The researchers analyzed data on nearly 100,000 patients enrolled in the study between 2007 and 2010. More than 80,000 patients received silicone implants (Allergan or Mentor); the rest received saline implants. Seventy-two percent of the patients underwent primary breast augmentation, 15 percent had revision augmentation, 10 percent had primary breast reconstruction, and three percent had revision reconstruction procedures.
The authors found silicone implants are generally safe but are also associated with a slightly higher risk of a few rare diseases including Sjogren’s syndrome (8-fold increase), scleroderma (7-fold increase), rheumatoid arthritis (6-fold increase), stillbirth (4.5-fold increase), and melanoma (4-fold increase). One case of BI-ALCL (rare lymphoma associated with textured implants) was reported.
The findings have been disputed by many experts, including federal health regulators, who nevertheless scheduled the public meeting to consider implant safety.
“These findings aren’t meant to suggest implants caused these problems,” said Dr. Mark Clemens, an MD Anderson professor of plastic surgery, Breast Advocate App contributor, and the senior investigator of the study. “They’re associations, which underscore the need for more research in this area, but do provide key safety information for women and their providers to consider when thinking about cosmetic or reconstructive surgery with breast implants.”
Since the publication, the FDA has also issued a statement acknowledging that implantable devices, including breast implants, may make some people sick. “A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices… [which can include] inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.”
Following the hearing and consideration of all the information presented, the FDA released this statement.
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).