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Update: FDA reports on new cancers linked to breast implants

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Contents

What is BIA-SCC? Clinical trials
What does this mean for me? Related resources
Questions for your doctor Finding Experts
Guidelines  

 

UPDATE AT A GLANCE

What is this update about?

This update is about a new safety communication about rare cancers found in the capsule of scar tissue that forms around breast implants.
 

Why is this update important?

Over the years, the has received reports of harmful events linked to breast implants. People who are making decisions about breast reconstruction or breast augmentation should be informed of any risks associated with breast implants. Healthcare providers should also be aware of these risks so they can properly inform individuals who are considering implants and monitor their patients who have breast implants.

Previously, the reported on a possible link between breast implants and a rare called anaplastic large cell (BIA-ALCL) and breast implant illness (BII).  For more on this topic see our XRAY reviews and information here. As a result of these findings, the has been more closely monitoring possible side effects related to breast implants.

This update reports on a very rare type of skin cancer called breast implant-associated squamous cell carcinoma (BIA-SCC) and cancers of the immune system called lymphomas that have been reported to arise in the scar tissue that forms a capsule around breast implants.
 

What is BIA-SCC?

Squamous cell carcinoma (SCC) is the second most common type of skin cancer. SCC is most commonly found in sun-exposed areas of the body. However, although very rare, it has long been known that SCC can develop in scar tissue. BIA-SCC develops in the capsule of scar tissue that forms around breast implants. Treatment for BIA-SCC involves surgery to remove the implant and surrounding capsule.

As of August 2022, 16 cases of individuals with BIA-SCC have been reported in the medical literature.  As of September 1, 2022, the has received 10 medical device reports about BIA-SCC.
 

What is ?

is cancer that starts in the infection-fighting cells of the immune system called lymphocytes. There are many types of .

Scientists do not fully understand all of the causes of . However, people who have been infected with HIV, Epstein-Barr or certain other viruses, exposed to high levels of ionizing radiation, have a family history of or have been exposed to high levels of pesticides, herbicides or certain other chemicals are at higher risk for developing .
 

How are these cancers detected?

Symptoms of BIA-SCC and at the site of a breast implant may include:

  • delayed seroma (fluid collection in the space around a breast implant that develops a year or more after breast surgery)
  • swelling
  • pain
  • capsular contracture (the scar tissue around the implant becomes unusually hard, starts to contract and may distort the size or shape of the implant)
     

How common is BIA-SCC or in the capsule around a breast implant?

In a typical year, about 400,000 women get breast implants in the United States. Of these, about 300,000 get implants for cosmetic reasons while approximately 100,000 get implants for reconstruction after mastectomies that are performed to treat or prevent breast cancer. Currently, 6.5 million people in the U.S. are estimated to have breast implants.

Very few cases of BIA-SCC and (not BIA-ALCL) have been reported in the literature or to the , and risk estimates are not yet available.

  BIA-SCC BIA-ALCL

Cases to date

16 in literature; 2 reported to the American Society of Plastic Surgeons; 10 medical devices reports to

30 cases in literature; 12 Medical device reports to

400 cases in the United States

(1,227 worldwide)

Frequency

28 (of 6.5 million in U.S.)

42 (of 6.5 million in U.S.)

400 (of 6.5 million in U.S.)

Risk

Unknown

Unknown

1:2,207-1:86,029*

*Varies by implant type

Average length of time since initial implantation

About 20 years

About 20 years

About 10 years

Implant surface

Smooth or textured

Smooth or textured

Textured

Implant type

Silicone or saline

Silicone or saline

Silicone or saline

 

It is important to know that BIA-SCC and lymphomas associated with breast implants are very, very rare. About 1 in 217,000 people with breast implants may be diagnosed with BIA-SCC, while about 1 in 162,500 may be diagnosed with . It is equally important to note that it is unclear whether these very rare cancers are caused by breast implants or other coincidental events.
 

Context

In response to breast implant data collected by the , the agency issued a safety alert for BIA-SCC and in the scar tissue around breast implants. This does not mean people with breast implants should have them removed. The advises that surgery to remove breast implants is not recommended unless a person is having symptoms related to either cancer. 

Conclusions

Most women with breast implants are satisfied with their results. However, breast implants are associated with known risks. Very few people have reported that they have developed BIA-SCC or in the scar capsule surrounding their breast implant.

What does this mean for me?

Some people do not experience any problems with their implants.  Breast implants are not lifetime devices. Most silicone and saline implants are approved for 10-20 years and the American Society of Plastic Surgeons recommends breast implants be exchanged or removed approximately every 10-15 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 think you have a problem with your breast implant(s), the encourages you to report the problem through the MedWatch Voluntary Reporting Form

It is also important to know that there are other options for breast reconstruction. Autologous breast reconstruction uses a person’s own fat, skin and/or muscle to reconstruct the breast. In addition, some people opt to go flat.

Reference

U.S. Food and Drug Administration. Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: Safety Communication. Published on September 8, 2022.

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.

 

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posted 9/27/22

This article is relevant for:

People with breast implants

This article is also relevant for:

People with breast cancer

Healthy people with average cancer risk

Previvors

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Expert Guidelines
Expert Guidelines

The issued guidelines for use of breast implants: 

  • Breast implant manufacturers are required to include a label warning and a patient decision checklist with all implants:
    • The checklist should include the current incidence rates of breast implant-associated anaplastic large cell (BIA-ALCL) and breast implant illness (BII).
    • The checklist should also include specific information regarding ongoing patient registries.
  • The has provided breast implant manufacturers specific language for an informational card that should be given to all patients following placement of breast implants. The card should include:
    • the serial number, lot number, device style, device size and the unique device identifier (UDI) of the implant.
    • weblinks to the most up-to-date access to the patient device checklist, boxed warning and labeling of the specific implant.
  • In collaboration with the and breast implant manufacturers, the American Society of Plastic Surgeons and the Plastic Surgery Foundation launched the National Breast Implant Registry (NBIR) in September 2018. The purpose of this database is to collect information from plastic surgeons on breast implant procedures to help improve the quality of care for all patients.

Updated: 12/15/2021

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • How often should I see a board-certified plastic surgeon, even if I have no concerns about my breast implants?
  • How often should I have an to show whether my silicone breast implants have ruptured?
  • How can I get a copy of the manufacturer’s safety information for the implants I am considering or already have?
  • How long can I expect to have my breast implants before they need to be replaced?

Open Clinical Trials
Open Clinical Trials

The following are studies related to breast reconstruction or no reconstruction after mastectomy.

Updated: 09/15/2022

Find Experts
Find Experts

Updated: 09/15/2022

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