Millions of women in the United States have breast implants, with approximately 400,000 new implant procedures performed annually1 2. While breast implants are widely used for cosmetic and reconstructive purposes, recent FDA safety communications have highlighted rare but serious cancer risks associated with these devices. These include newly identified cancers such as breast implant-associated squamous cell carcinoma (BIA-SCC) and various lymphomas distinct from the previously known breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) 34. Understanding these risks is essential for patients and healthcare providers to ensure timely detection and appropriate management.
“BIA-ALCL is an emerging risk of textured implants and patients should be aware when choosing the implant that is right for them.”
— American Society of Plastic Surgeons10
Breast Implants and New Cancer Risks
Breast implants are medical devices implanted under breast tissue or chest muscle to increase breast size or reconstruct the breast after mastectomy or trauma. There are two main types approved by the FDA: saline-filled and silicone gel-filled implants, both with silicone outer shells that vary in texture (smooth or textured), size, and shape5 3.
BIA-ALCL is a rare T-cell non-Hodgkin lymphoma that develops primarily in the scar tissue (capsule) surrounding textured breast implants6 7. As of 2023, over 1,200 cases have been reported worldwide, with the majority linked to textured implants, especially Allergan BIOCELL products7 8. The FDA has issued boxed warnings and requested a global recall of these Allergan textured implants due to their significantly higher risk of BIA-ALCL compared to other implants6 8.
BIA-ALCL is not a breast cancer but a lymphoma of the immune system located in the peri-implant capsule. It typically arises about 10 years after implantation and may metastasize if untreated9 . Symptoms include unexplained breast swelling, pain, lumps in the breast or armpit, and skin changes10 . Early diagnosis and treatment, which involves removal of the implant and capsule, often lead to a cure. Advanced cases may require chemotherapy, radiation, or stem cell transplantation11 10.
BIA-SCC is an even rarer cancer linked to breast implants, arising in the fibrous capsule around both textured and smooth implants filled with saline or silicone2 3. Squamous cell carcinoma (SCC) is commonly a skin cancer but can develop in scar tissue, including the capsule formed around breast implants3 . As of early 2023, fewer than 20 cases have been reported to the FDA, with about 19 cases documented in the medical literature2 4.
BIA-SCC can be aggressive and may spread to local tissues such as muscle, bone, lymph nodes, and distant organs10 . It typically presents with symptoms like breast swelling, pain, lumps, or skin discoloration4 . Treatment usually involves surgical removal of the implant and the entire capsule (en bloc capsulectomy) 10. Due to its rarity, risk factors for BIA-SCC remain unclear, and it has been reported in patients with various implant types and reasons for implantation, including cosmetic augmentation and reconstruction2 3.
In addition to BIA-ALCL and BIA-SCC, the FDA has received reports of other lymphomas and mesenchymal tumors, including sarcomas, arising in the capsule around breast implants12 5. These cancers are extremely rare, with fewer than 30 cases reported worldwide12 . The incidence of these malignancies remains very low despite millions of women living with breast implants6 12.
“Patients frequently ask about the safety of implants. The FDA has deemed breast implants reasonably safe and effective, and being educated about potential complications is an important part of good health.”
— Mark W. Clemens, M.D., MD Anderson Cancer Center16
| Cancer Type | Reported Cases (FDA) | Implant Type Association | Notes |
|---|---|---|---|
| BIA-ALCL | >1,130 | Primarily textured implants | Rare T-cell lymphoma; FDA boxed warning |
| Squamous Cell Carcinoma (SCC) | <20 | Both textured and smooth; saline and silicone | Very rare; found in implant capsule |
| Other lymphomas | <30 | Various implant types | Rare; under investigation |
The FDA recommends that patients with breast implants monitor for any changes such as lumps, swelling, pain, skin changes, or alterations in implant size or shape9 13. Prompt medical evaluation is critical if these symptoms occur. Routine medical care and imaging, including ultrasound or MRI, are advised to detect complications such as implant rupture or malignancy5 10.
Healthcare providers and patients are encouraged to report any cases of cancers associated with breast implants to the FDA's Safety Information and Adverse Event Reporting program and to registries such as the PROFILE registry, which collects data on BIA-ALCL and is expanding to include BIA-SCC and other implant-associated cancers10 4.
💡 Did You Know? There have been reports of squamous cell carcinomas (SCC) and various lymphomas of the breast in the capsule or scar tissue of breast implants, although these cancers are very rare14 .
Other Breast Implant Health Concerns
Beyond cancer risks, breast implants are associated with several other health issues and complications that patients should be aware of.
Breast implant illness refers to a broad cluster of systemic symptoms reported by some patients with breast implants. These symptoms include fatigue, joint and muscle pain, memory and concentration problems ("brain fog"), depression, chronic flu-like symptoms, migraines, and skin rashes15 10. BII lacks formal diagnostic criteria, making it challenging to diagnose definitively. However, some women report symptom improvement after implant removal15 10.
Clinicians are urged to approach patients reporting these symptoms with empathy and conduct thorough evaluations to rule out other inflammatory or autoimmune diseases15 10. Research is ongoing to better understand the causes and risk factors of BII.
Breast implants are not lifetime devices. The longer implants remain in place, the higher the risk of complications, many of which may require additional surgeries5 1. Common complications include:
- Capsular contracture: Hardening and tightening of the scar tissue around the implant, causing firmness, pain, and distortion of breast shape5 .
- Implant rupture or deflation: Tears or holes in the implant shell leading to leakage of saline or silicone gel, sometimes without symptoms ("silent rupture") 5.
- Infection, hematoma, and delayed wound healing5 .
- Changes in nipple or breast sensation5 .
- Breast asymmetry, malposition, and visibility or palpability of the implant5 .
Surgical options for managing complications include implant removal with or without replacement, capsulectomy (removal of scar tissue), and drainage of fluid collections5 . Patients should discuss with their surgeons the best approach based on their individual situation.
💡 Did You Know? The FDA recommends MRI or ultrasound screening for silicone breast implant rupture starting 5-6 years after implantation and every 2-3 years thereafter, even if no symptoms are present5 .
Some women with breast implants can successfully breastfeed, while others may have difficulties, especially after mastectomy and reconstruction5 . Studies have not found increased risks of birth defects or congenital malformations in children born to mothers with implants, though some reports suggest possible associations with low birth weight that require further research5 16.
The FDA requires breast implant manufacturers to provide patients with detailed labeling, including a patient decision checklist and implant identification cards, to inform them of risks and benefits before surgery5 10. The American Society of Plastic Surgeons (ASPS) and Plastic Surgery Foundation (PSF) have developed registries such as the National Breast Implant Registry (NBIR) and PROFILE to collect data on implant procedures and associated complications, improving patient safety and research10 .
Patients are encouraged to maintain records of their implant type and manufacturer and to report any adverse events or symptoms to their healthcare providers and the FDA10 5.
