Breast cancer survivors
Her2+ breast cancer
People with a genetic mutation linked to cancer risk
Triple negative breast cancer
Women under 45
Women over 45
Special populations: People with BIOCELL breast implants
On July 25, 2019, the Food and Drug Administration requested that breast implant manufacturer Allergan recall its BIOCELL textured implants and expanders due to an association with a rare type of lymphoma called Breast Implant Associated Anaplastic Large Cell Lymphoma or BIA-ALCL. The FDA does not recommend removing implants for people who do not have disease symptoms. This XRAYS review updates information about this FDA recall. (7/29/19)
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A recall of Allergan BIOCELL textured implants and expanders, which have been associated with a rare type of lymphoma called Breast Implant Associated Anaplastic Large Cell Lymphoma or BIA-ALCL.
There have been reports of rare but serious cancer and deaths associated with a particular type of textured breast implants and expanders. This recall removes Allergan BIOCELL textured implants and expanders from the global market. Allergan is voluntarily cooperating.
Key points of statement:
Some individuals with breast implants develop an uncommon form of lymphoma, breast-implant associated anaplastic large cell lymphoma (BIA-ALCL).
XRAYS has reviewed previous FDA statements on implants and BIA-ALCL:
Key points about BIA-ALCL:
If you already have breast implants
For women who have breast implants, there is no need to change your routine medical care. Experts do not recommend removing breast implants if you do not have signs or symptoms of BIA-ALCL or other implant related issues.
If you have implants, it is recommended that you:
If you are undergoing implant removal for suspected BIA-ALCL
If you have been diagnosed with BIA-ALCL, please inform your current health care provider and surgical team. Make sure that your surgical team is familiar with the recommendations for surgery in people with BIA-ALCL. Implant removal surgery for BIA-ALCL or suspected BIA-ALCL differs from standard implant removal surgery. For those with BIA-ALCL, the implant and neighboring scar tissue are removed. Your surgeon may also collect fresh fluid and tissue around the scar capsule to confirm BIA-ALCL.
If you have been diagnosed with BIA-ALCL
The FDA is collecting data on all cases of BIA-ALCL with any type of implant or expander. Collection of information about serious adverse events or death is important to have an accurate understanding of the effect of these (or any) devices. If you have breast implants or expanders and have been diagnosed with BIA-ALCL, you can report that information in one of three ways:
If you are considering breast reconstruction
Patients who are concerned about possible long-term complications of implant reconstruction should be aware of alternatives such as flap reconstruction using your body’s own fat, or no reconstruction. Your plastic surgeon can provide information about alternative options.
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The New York Times
Breast implants come in different sizes and shapes, contain 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 with smooth-surfaced implants. Textured implants account for about 10% of all breast implants; only 5% of breast implants are macro-textured like the ones that have been recalled. Due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with Allergan's BIOCELL textured breast implants, the FDA requested that Allergan recall the BIOCELL related textured implants and expanders from the global market and Allergan agreed. All of the recalled products have a textured surface that is found only on Allergan BIOCELL based implants or expanders
BIA-ALCL is uncommon:
To date, 573 patients have reported cases of BIA-ALCL:
It is important to note that most cases of BIA-ALCL occurred in individuals who have textured-surface implants regardless of whether they had saline or silicone filling. Nor is there an association with breast cancer. BIA-ALCL is as likely (or unlikely) to occur in women who choose implants for cosmetic reasons as it is in women who choose them for breast reconstruction following a mastectomy.
Cases of BIA-ALCL have been reported in women with smooth implants or other types of textured implants but at lower rates than with Allergan textured implants.
Most women who have textured implants have devices made by Allergan. Textured implants of other manufacturers (Mentor, Sientra) are not involved in this recall, and current data does not implicate them at this point. This may be because other manufacturers’ implants do not cause BIA-ALCL, there are too few of them in use to detect an increased rate of this uncommon disease, or because of underreporting by manufacturers, surgeons and patients.
The data available are a collection of personal reports by patients rather than results from a controlled study. In some cases, a patient's medical history makes it difficult to determine how implants affect her health. Because breast implants and expanders have a limited life and need to be replaced, some individuals have had more than one type of implant or expander in their lifetime. For example, an individual who had textured implants for several years may have had them removed and replaced with smooth implants, and then later developed BIA-ALCL. In this case, it would be difficult to determine which implants may have led to the diagnosis. This type of nuance makes it difficult to determine the effect of particular types or brands of devices, particularly when the disease is rare and the number of individuals affected is quite small.
In May, the FDA released a statement on the agency’s new efforts to protect women’s health and help to ensure the safety of breast implants. The statement follows a 2-day meeting on the safety of breast [link to: https://www.facingourrisk.org/get-involved/HBOC-community/BRCA-HBOC-blogs/FORCE/breast-reconstruction/update-fda-meeting-on-breast-implant-safety/] implants and the surgical mesh frequently used in reconstructive surgeries. FDA staff and members of the General and Plastic Surgery Devices Advisory Committee were joined by industry representatives, professional societies, and members of the public to review the data available, and to make recommendations for future use. A FORCE representative attended the meeting and made remarks during the public comments period on March 26.
FORCE is participating in a Breast Device Collaborative Community to advise the FDA on important issues related to breast implants, including improved informed consent and implant monitoring. FORCE continues to follow and weigh-in on this topic and will keep the community informed.