Guideline: FDA asks Allergan to recall certain textured breast implants

Contents

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:

• FDA report claims women with breast implants may be at risk for rare cancer  (4/21/17).
• FDA updates report on risk of lymphoma from breast implants (4/2/18).

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.

Posted 7/29/19

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References

FDA statement: The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication (July 25, 2019)

FDA press release: FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market (July 24, 2019)
 

Disclosure

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.