Guideline: FDA asks Allergan to recall certain textured breast implants


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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)

Contents

At a glance                  In-depth 
BIA-ALCL-symptoms, diagnosis and treatment    Limitations                                                            
Questions for your doctor Resources and references


AT A GLANCE

This statement is about:

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.

Why is this statement important?

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:

  • Allergan BIOCELL textured implants and expanders have been recalled (see full list of devices here). This means that surgeons will no longer be able to use these implants for breast reconstruction or augmentation in the future.
  • The FDA does not recommend removal of textured implants for women who have no symptoms of BIA-ALCL or other implant-related complications because their risk of developing this disease is low.

Statement background:

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:

  • BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system). It is not breast cancer.
  • BIA-ALCL is rare. Recent reports estimate that the lifetime risk of developing BIA-ALCL ranges from between 1 in 1,000 to 1 in 30,000 for women with textured breast implants.
  • BIA-ALCL is most often found in the scar tissue and fluid near the breast implant, but it can spread throughout the body.
  • BIA-ALCL appears to develop more frequently with textured implants than smooth-surfaced implants.
  • BIA-ALCL can occur years after implant surgery.
  • BIA-ALCL can be treated successfully if caught early.
  • BIA-ALCL is a serious diagnosis and can lead to death if it is not diagnosed early and promptly treated. 

BIA-ALCL symptoms, diagnosis and treatment

  • Persistent or recurrent swelling of the breast is the most common symptom associated with BIA-ALCL. This can occur as long as 28 years after the implant surgery. Other symptoms can include a lump in the breast or in underarm lymph nodes or asymmetry in the breast with the expander or implant. Less common symptoms include skin rash on the breast, fever and weight loss.
  • Testing for BIA-ALCL may include a doctor's exam, breast imaging and removal of fluid or tissue around the implant for evaluation.
  • BIA-ALCL can be treated successfully In most patients. According to the Association for Plastic Surgeons, "all cases of BIA-ALCL with disease limited to the scar tissue around the breast capsule and treated with complete surgical excision have been cured." Most cases are treated  with surgery to remove the implant and the scar tissue surrounding the implant. Some patients may require treatment with chemotherapy and/or radiation therapy. Although rare, BIA-ALCL has led to death for 33 patients to date.

What does this mean for me?

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:

  • Make sure that you have the product information card that came with your implants. You should have received this information from your surgeon. Here is a tip page for locating your implant information. 
  • Know how your natural or reconstructed breasts look and feel, and notify your health care providers immediately if you notice any changes.
  • Talk to your doctor about breast MRI (magnetic resonance imaging) to check for implant ruptures or other implant-related issues, particularly if you have silicone implants. (The FDA recommends an MRI 3 years after your initial implant surgery and every 2 years thereafter if you have silicone implants.)
  • If you have textured breast implants, you may want to talk to your health care provider about your risks and how to identify potential symptoms.
  • If you have any implant-related health issues, speak with your surgeon about the benefits and risks of removing or exchanging your implants.

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:

  • Inform your health care provider, who can report cases via the appropriate MedWatch form and register cases in PROFILE registry to help further understanding of BIA-ALCL.
  • Voluntarily report severe adverse events including BIA-ALCL directly to the FDA using the MedWatch Voluntary Reporting Form.
  • Alternatively, you can report severe adverse events to the device manufacturer, who is obligated to report all severe adverse events and deaths to the FDA.

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.

Share your thoughts on this XRAYS article by taking our brief survey.

Questions To Ask Your Health Care Provider

  • What are the pros and cons of breast implants?
  • What are the pros and cons of textured and smooth breast implants?
  • What are the BIA-ALCL symptoms that I should be aware of after I get breast implants?
  • I had surgery years ago. How can I find out what type of implants I have?
  • I have BIOCELL implants, what are the pros and cons of having them removed?
  • I have BIOCELL implants and want to have them removed, will my insurance pay for it?
  • What breast reconstruction options do not involve implants?
  • What factors should I consider when deciding between different breast reconstruction options?
  • What type of follow up should I have after mastectomy and reconstruction? Should I have breast MRI?  If so, how frequently? Will my insurance pay for these follow-ups?

IN-DEPTH REVIEW OF RECALL

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:

  • During 2017, the American Cancer Society predicts diagnosis of 72,240 non-Hodgkin lymphoma cases, of which only 1,500 to 2,100 will be BIA-ALCL. Using these figures, the occurrence of ALCL in the United States is about 5 cases per million people..
  • BIA-ALCL is diagnosed in women who have breast implants. Approximately 450,000 women in the U.S. get breast implants for cosmetic or reconstruction purposes annually.
  • Recent reports estimate that the lifetime risk of developing BIA-ALCL ranges from between 1 in 1,000 to 1 in 30,000 for women with textured breast implants.

Data that prompted the recall

To date, 573 patients have reported cases of BIA-ALCL:

  • 481 patients had Allergan BIOCELL implants at the time of their diagnosis.
     
  • 33 BIA-ALCL-related patient deaths have been reported:
    • 20 patients had breast implants of an unknown type.
    • 12 of 13 patients who had a known type of implant had Allergan BIOCELL implants at the time of diagnosis.
       
  • The FDA estimates that the risk of BIA-ALCL is approximately 6 times greater with Allergan BIOCELL textured implants than with textured implants from other manufacturers.  This elevated risk led to this recall.
     
  • The vast majority of women with Allergan textured implants or expanders have not reported symptoms of BIA-ALCL.

Limitations and additional issues

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.

Additional Efforts

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.

Posted 7/29/19

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