Update: FDA reports on new cancers linked to breast implants

Contents

UPDATE AT A GLANCE

What is this update about?

This update is about a new FDA 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 FDA 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 FDA reported on a possible link between breast implants and a rare lymphoma called anaplastic large cell lymphoma (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 FDA 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 FDA has received 10 medical device reports about BIA-SCC.
 

What is lymphoma?

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

Scientists do not fully understand all of the causes of lymphoma. 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 lymphoma or have been exposed to high levels of pesticides, herbicides or certain other chemicals are at higher risk for developing lymphoma.
 

How are these cancers detected?

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

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 lymphoma. 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 FDA, the agency issued a safety alert for BIA-SCC and lymphoma in the scar tissue around breast implants. This does not mean people with breast implants should have them removed. The FDA 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 lymphoma 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 FDA 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 FDA 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: FDA 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