Study: FDA updates report on risk of lymphoma from breast implants
|At a glance
|What does this mean for me?
|Questions for your doctor
This study is about:
An update to a previous report on the increased risk of anaplastic large cell , a rare type of non-Hodgkin , in women who have breast implants.
Why is this report important?
Patients who are making decisions about breast reconstruction or breast augmentation should be informed of any possible link between anaplastic large cell (ALCL) and breast implants. Healthcare providers should also be aware of this link so they can properly monitor women who have breast implants.
Previously, the had received 359 medical device reports (also known as reports), including 9 deaths, of breast implant-associated anaplastic large cell (BIA-ALCL). Of these:
- 203 involved textured implants; 28 involved smooth implants
- 186 involved silicone implants; 126 involved saline implants
As of September 2017, the had received a total of 414 medical device reports of BIA-ALCL, including the death of nine patients.
- 242 involved textured surfaces; 30 involved smooth surfaces
- 234 involved silicone implants; 179 involved saline implants
While the number of cases of BIA-ALCL has increased, the number of deaths remains the same. It is important to note that most cases occurred in individuals who have textured-surface implants, and that no association has been made between BIA-ALCL and the interior material (saline or silicone) of the implant. Nor is there an association with breast cancer. BIA-ALCL is as likely to occur in women who choose implants for cosmetic reasons as it is in women who choose them for breast reconstruction following a mastectomy.
Recent reports estimate that the lifetime risk of developing BIA-ALCL ranges from between 1 in 3,817 to 1 in 30,000 for women with textured implants.
The no longer recognizes BIA-ALCL as a rare condition (instead, it reports estimated risk). However, while it is not known how many women currently have breast implants, it is important to note that in the United States an estimated 450,000 women get breast implants each year. Considering the number of women who receive breast implants, the risk for BIA-ALCL is very low.
The is still collecting data; as new data is added it may impact current risk estimates. Since the began collecting data, the known risk has increased and this trend may continue as more data comes in.
Breast implants come in different sizes and shapes, have different types of fillings (silicone or saline) and have either smooth or textured surfaces (shells). BIA-ALCL appears to develop more frequently with textured implants than smooth-surfaced implants. Before getting breast implants, talk to your health care provider about the benefits and risks of both textured-surface and smooth-surfaced implants.
Patients who are concerned about possible long-term complications of implant reconstruction should be aware of alternatives such as reconstruction or no reconstruction. If you are interested in alternative options, discuss these with your health care provider.
If you already have breast implants, there is no need to change your routine medical care, and currently, removing breast implants is not currently recommended by the if you do not show signs or symptoms of BIA-ALCL (unless you develop unrelated issues with your breast implants). According to the report, the most common symptom of BIA-ALCL is swelling around the implant, which can occur from 2 to 28 years after surgery. You should also contact your health care provider if you notice redness, pain, lumps or breast asymmetry.
Note: On 07/25/19, the announced a recall of Allergan BIOCELL textured implants and expanders, due to their association with BIA-ALCL. On October 27, 2021 the announced stronger guidance on breast implant safety.
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U.S. Food and Drug Administration. “Breast Implant-Associated Anaplastic Large Cell (BIA-ALCL).” Published on March 2018.
FORCE XRAYS. " report claims women with breast implants may be at risk for rare cancer." Published April 17, 2017.
FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
This article is relevant for:
Women who currently have textured implants or expanders or who have had them in the past
This article is also relevant for:
people with breast cancer
Be part of XRAY:
NCCN has outlined principles of breast reconstruction or going flat following mastectomy surgery. These include the following:
- All patients undergoing breast cancer treatment should be educated about breast reconstructive options based on their situation.
- Selection of reconstruction option is bassed on many factors, including cancer treatment, patient preference, obesity, smoking history, comorbidities and patient concerns.
- Patients may chose not to have breast reconstruction after mastectomy. The option of mastectomy with no reconstruction and optimized closure (aesthetic flat closure) should be part of the discussion of patients' options after mastectomy.
- Breast reconstruction or going flat should be a shared decision between the patient and their surgeon.
- What are the pros and cons of breast implants?
- What are the pros and cons of textured and smooth breast implants?
- What symptoms should I look for after I get breast implants?
- What options for breast reconstruction do not involve implants?
- What factors should I consider when deciding between different breast reconstruction options?
- I am considering/have had a risk-reducing prophylactic mastectomy with breast implants. Should I be worried about developing BIA-ALCL?
- Should I have breast after mastectomy and reconstruction with implants? If so, how frequently?
The following are studies related to breast reconstruction or no reconstruction after mastectomy.
- NCT05720039: Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction for Women With Breast Cancer. This study will compare robotic-assisted nipple sparing mastectomy (NSM) to standard surgery NSM for women with early breast cancer.
- NCT02918474: Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer. This trial studies the acceptability and how well decision making tool works in supporting decision making in contralateral prophylactic mastectomy in patients with newly diagnosed breast cancer.
- NCT04533373: Sensory Restoration After Flap Neurotization. The goal of this study is to look at how well a nerve graft works for improving sensation to the reconstructed breast after mastectomy in people undergoing flap reconstruction.
NCT05020574: Microbiome and Association With Implant Infections. The study is looking at whether people with high amounts of certain types of bacteria are more likely to develop tissue expander-related infections than those with lower amounts of bacteria.
The following resources can help you find a plastic surgeon who specializes in breast reconstruction:
Finding a plastic surgeon
- The American Society of Plastic Surgeons has a searchable Plastic Surgeon Referral Service database.
Other ways to find experts
- Register for the FORCE Message Boards and post on the Find a Specialist board to connect with other people who share your situation.
- The website for the Breast Reconstruction Guidebook provides information on Choosing the Right Surgeon.
Who covered this study?
New York Times
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