5 Things to Know About Silicone Breast Implants, Cancer and Cosmetic Breast Surgery

"Should I have breast implant surgery?"

"Is there an alternative to silicone breast implants?"

"Will the implant need replacing later?"

Breast implants, often called "breast silicone," are medical devices, and deciding to undergo cosmetic breast surgery raises even more questions.

"Should the implant be saline or silicone?"

"Should its surface be smooth or textured?.."

These are common questions people consider when thinking about breast implants.

The United States Food and Drug Administration, FDA, prepared the following information to help people seeking information and advice when deciding about implants.

Basic Information About Breast Implants

The FDA approved implants for women for breast augmentation, reconstruction after breast cancer surgery or trauma, and correcting developmental abnormalities. They are also approved to correct or improve previous surgical results.

Several human trials have reported that most patients undergoing breast augmentation and reconstruction are satisfied with the surgical results.

The FDA approved two implant types sold in the United States: saline-filled and silicone gel-filled. Both have an outer silicone shell; size, shell thickness and shape may vary. This is why breast implants are often called "silicone."

Potential Harms of Breast Implants

FDA-approved implants have undergone extensive testing to assure safety and effectiveness.

However, all breast implants carry certain risks, including:

• Additional operations
• Breast implants have been associated with a rare hematological cancer, anaplastic large cell lymphoma . Anaplastic large cell lymphoma accounts for %2 of all lymphomas.
• Capsular contracture, a type of scar tissue 
• Breast pain
• Rupture allowing saline or silicone gel to escape the implant
• Silent breakage or rupture of silicone gel-filled implants without signs or symptoms
• Infection

If considering breast implants, here are 5 tips:

1. Accept That Breast Implants Are Not Lifetime Devices

Longer use increases the risk of complications requiring more surgery. Implant lifespan varies between people and cannot be predicted. Very few people can use implants for 20 to 30 years. Patients may also request additional surgery to change cosmetic appearance, such as size or shape.

2. Review the Product Label

The FDA recommends reviewing the Summary of Safety and Effectiveness Data to learn each implant's characteristics and filling material. Summaries exist for all approved saline and silicone gel-filled implants, covering uses, risks, warnings, precautions and FDA approval studies. They also describe how often serious complications occur. The most serious complications are those leading to further surgery, such as rupture or capsular contracture.

The FDA recommends healthcare professionals provide patients with all product information through these labels. Ask your surgeon for the latest information and read it carefully. Discuss any questions about the documents with your surgeon.

3. Communicate with Your Surgeon

Surgeons should assess implant shape, size, surface texture, placement and incision site for each person. Draw on the surgeon's experience by asking about cosmetic breast surgery, the procedure and how implants may affect your life.

Also ask your surgeon to consider previous operations, your body's reactions (such as more scarring than expected) and expectations. Many people undergo additional operations to change implant size. Careful planning and realistic expectations are important for the best results after the initial surgery.

4. Learn About Long-Term Risks

The FDA identified an association between breast implants and anaplastic large cell lymphoma (ALCL), a non-Hodgkin lymphoma. People with implants may have a greater risk of ALCL in fluid or scar tissue around the implant. Approved implants may be saline- or silicone gel-filled, in different sizes and shapes with smooth or textured shells. ALCL develops mainly in people with textured rather than smooth implants. Remember that, like other lymphomas, ALCL is a cancer of the immune system, not breast tissue.

For Every 100 Million Implants, 3 Cancer Cases

Implant-associated large cell lymphoma's risk is very low; since its first identification in 1997, only about 400 cases have been reported in the literature, with, per 100 million women, an estimated 3 new cases diagnosed annually.

Although some women with implants report connective tissue diseases such as lupus and rheumatoid arthritis, breastfeeding problems or reproductive difficulties, current evidence suggests no association between implants and these conditions.

5. Understand the Importance of Follow-Up

Generally, follow your doctor's instructions on monitoring your implants.

If you notice any unusual signs or symptoms, report changes to your doctor immediately. Also follow instructions on implant monitoring and routine breast cancer mammography screening . When booking, tell the mammography facility you have implants. Your doctor may also recommend magnetic resonance imaging (MRI) or other tests. The FDA recommends MRI screening for people with silicone implants three years after surgery and every two years thereafter to detect silent rupture.