Update: FDA updates reported harmful events linked to breast implants

Contents

UPDATE AT A GLANCE

This FDA update is about:

Newly reported cases of breast implant-associated anaplastic large cell lymphoma and breast implant illness. This new report provides an update on a prior FDA report which was covered in this XRAY review. Note: On October 27, 2021 the FDA announced stronger guidance on breast implant safety.

Why is this FDA update important?

Over the years, the FDA has received reports of harmful events linked to breast implants. Patients who are making decisions about breast reconstruction or breast augmentation should be informed of any possible link between breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII). Healthcare providers should also be aware of this association so they can properly monitor people who have breast implants.

This update reports new cases and deaths due to BIA-ALCL and new cases of BII. This update also includes the approval of the BREAST-Q Reconstruction Module, a survey tool that can be used to report on quality of life and satisfaction with their breast implants.

What is breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)?

BIA-ALCL is not breast cancer.  It is a cancer of the immune system called lymphoma. In most cases, BIA-ALCL is found in the scar tissue and fluid around the breast implant. If left untreated, BIA-ALCL can spread throughout the body. 

What are the symptoms of BIA-ALCL?

The most common symptom of BIA-ALCL is fluid around the implant. It can also present as a mass or growth associated with the implant capsule (scar tissue around the implant). The breast may also be swollen or painful. Most cases of BIA-ALCL have been diagnosed 8 to 10 years after implants are placed.

How is BIA-ALCL treated?

BIA-ALCL can be successfully treated.  However, it is a serious condition. It can be fatal, especially if it is not diagnosed and treated early. Treatment usually includes surgery to remove the implant and surrounding scar tissue or capsule. Some patients may require additional treatment with chemotherapy and/or radiation therapy.

How common is BIA-ALCL?

It is important to know that BIA-ALCL is very rare. It is more commonly found in people with textured implants than in those who have implants with a smooth surface. About 35 million people worldwide have textured implants. Globally, the number of people who have developed BIA-ALCL is very, very low. To date, there have been 733 reported cases of BIA-ALCL and 36 deaths.
 

Worldwide reported cases and deaths due to BIA-ALCL

What is the risk of BIA-ALCL?

The risk of developing BIA-ALCL is very low. People with breast implants have about a 1-in-4,000 to 1-in-40,000 risk of developing this type of lymphoma. By comparison, on average, one in eight women in the U.S. will develop breast cancer during her lifetime.
 

What is breast implant illness (BII)?

Patients and healthcare providers use the term “breast implant illness” or “BII” to describe several symptoms that are believed to be due to breast implants.

What are the symptoms of BII?

BII symptoms vary and may be vague. The most common symptoms reported include

• fatigue (49 percent)
• brain fog (25 percent)
• joint pain (25 percent)
• anxiety (24 percent)
• hair loss (21 percent)
• depression (19 percent)
• rash (18 percent)
• autoimmune diseases (18 percent)
• inflammation (18 percent)
• weight problems (18 percent)

These symptoms have been reported with all types of breast implants. Some people report symptoms immediately after implantation, while others report symptoms years after receiving implants.

The period of time from implant placement to showing BII symptoms varies widely from immediately to over 40 years. On average, BII symptoms were reported about 5 years after having breast implants.

How Common is BII?

Currently, BII is not recognized as a single medical disease, and there are no tests to diagnose it. BII symptoms overlap with many other diseases, so it is hard to know how many people have BII or some other disease.

Each year in the U.S. about 300,000 people have surgery to place breast implants. To date, 3,577 cases of BII have been reported to the FDA.  Most of these reports—2,497 (70%)—were made between November 2018 to October 2019. The increase in reporting during this period may be due to awareness of BII from the press and social media.

How is BII treated?

There is no known treatment for BII. Some people report that their symptoms go away after their implants are removed. The FDA has received reports from only 290 people who have had their breast implants removed. Of these, 279 reported that their symptoms improved after their implants were removed, while 11 reported no improvement.

New FDA resources

Along with the alert, the FDA listed the following new resources. 

• BREAST-Q Reconstruction Module, a tool that collects patient data on psychological, sexual and physical well-being; quality of life and satisfaction with their breast implants.
• FDA video: Things to Consider Before Getting Breast Implants, a short video for women who are considering breast implants for augmentation or breast reconstruction.

What does this mean for me?

Due to data collected by the FDA on breast implants, they have issued a cautionary recall of all BioCell textured breast implants manufactured by Allergan. The recall does not mean all women with these implants should have them removed. The FDA advises that the surgery is not worth the risk unless a person is having symptoms.  The products included in the recall are:

• Natrelle Saline-Filled breast implants
• Natrelle Silicone-Filled breast implants
• Natrelle Inspira Silicone-Filled breast implants
• Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
• The recall also includes tissue expanders, including:
• Natrelle 133 Plus Tissue Expander
• Natrelle 133 Tissue Expander with Suture Tabs

Most people do not experience any problems with their implants.  However, breast implants are not lifetime devices, and they are associated with known risks. In a small number of people, breast implants are linked to BII. Breast implants are linked to BIA-ALCL in even fewer people. 

The FDA recommends replacing breast implants about every 10 years. However, many experts do not recommend replacing them unless there is an issue. The longer a person has had implants the more likely they are to experience rupture, wrinkling, rippling, asymmetry, breast pain and numerous other issues that may require surgery to resolve.

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.
• Alert your doctor if you think you have any implant-related health issues.
• Report implant-related health issues to the FDA by:  
  • completing the MedWatch Voluntary Reporting Form, or
  • 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 learn about the benefits and risks of breast reconstruction or no reconstruction.  Your plastic surgeon can provide information about your options.

Posted 10/20/20
 

Reference

FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma. FDA website. 
 

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.