A letter to patients from Dr. W. Tomasz Majewski:

In the past few years, concern about the safety of breast implants has become a recurring topic in the news. A recent update from the FDA connecting breast implants to a rare form of lymphoma has patients asking us: Are breast implants safe?

If you or someone you love has undergone or is considering undergoing breast augmentation, it is understandable to feel concerned about these reports. You should feel comforted to know that BIA-ALCL risk is extremely low and the disease has shown to be curable. Media reports about this and other medical topics are not the most reliable source of information - and we want to be sure that our patients have the most relevant, up-to-date, and research-backed information available.

Patient safety is the primary focus of our practice and the plastic surgery community as a whole - and we strive to always be open, honest, and research-driven in our approach. Here is everything you need to know about breast implants, BIA-ALCL, and the known risks of breast augmentation surgery.

What is BIA-ALCL?

BIA-ALCL, or Breast Implant Associated Anaplastic Large Cell Lymphoma, is a rare and highly treatable type of lymphoma that can develop around breast implants. This is a cancer of the immune system, not a form of breast cancer. When detected early, it has been shown to be highly curable.

Who Has Been Affected?

The links between breast implants and this rare form of lymphoma have primarily been found in patients who have breast implants with textured surfaces, including a type of shaped, textured implant called the gummy bear implant. There have only been a few reported cases involving smooth implants.

Why Would My Surgeon Have Recommended Textured Implants?

There are two primary reasons your surgeon may have recommended textured surface breast implants. The first is that some data has shown a lower rate of capsular contracture (firm scar tissue formation around the implant) with textured implants. Second, all teardrop or anatomic shaped implants have a textured surface to help hold them in place. Some surgeons believe these implants can offer an enhanced shape for certain patients, perhaps with a reduced risk of rippling.

WhaT IS MY RISK?

Every year, roughly 300,000 women in the US make the decision to get breast implants. Of those, about 12% choose textured implants. The current lifetime risk of BIA-ALCL is estimated to be 1 in 3,817 to 1 in 30,000 women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. This equals roughly .02% to .003% of women with textured implants.

According to the FDA, “All of the information to date suggests that women with breast implants have a very low but increased risk of developing anaplastic large-cell lymphoma compared to women who do not have breast implants.”

BIA-ALCL has been found with both silicone and saline textured implants, as well as in a few cases involving smooth implants. Of these, 56% had received implants for cosmetic reasons (to make their breasts bigger or fuller), and 44% for reconstructive reasons (to rebuild their breasts after they had been removed following breast cancer).

Overall, there seems to be a stronger link between textured implants and BIA-ALCL than smooth implants - although the risk of either is rare. Of the 359 reported cases of BIA-ALCL, the FDA had information on the surface of the breast implant in 231 cases:

203 were textured implants
28 were smooth implants

The material inside the implant (whether silicone or saline) did not seem to affect the risk of BIA-ALCL.

What are the Symptoms?

Several patients have expressed concern about whether they would be able to detect the presence of BIA-ALCL. The answer to this is largely yes: In most cases, women diagnosed with BIA-ALCL observed changes in the look or feel of the area surrounding the implant - including:

Swelling
Hardening
Fluid collection
Pain, or
An overlying skin rash around one or both breasts

Within the first year after breast augmentation, and especially in the first few months, it is not unusual to experience swelling, numbness, or tenderness in the breasts. These side effects are normal and should improve over time.

The women diagnosed with BIA-ALCL began experiencing their symptoms more than one year after their initial surgical sites were fully healed, and on average eight to ten years after receiving textured implants.

Is It Curable?

When caught early, BIA-ALCL is usually curable, because the lymphoma is almost always contained to the capsule (scar tissue) that forms around the implant. BIA-ALCL usually can be successfully treated surgically, by removing the implant and the scar tissue capsule. Additional treatments such as radiation therapy and chemotherapy usually aren’t needed, but may be recommended in some cases.

I Have Breast Implants - Should I Be Evaluated?

ASPS (the American Society of Plastic Surgery), ASAPS (the American Society of Aesthetic Plastic Surgery), and the FDA encourage all women with breast implants who are not experiencing any symptoms of BIA-ALCL to continue their routine follow-ups. This includes imaging of the breasts when appropriate, as well as the monthly breast self-exams which are recommended to all women (with and without implants) to check for any signs of breast cancer.

If you have experienced any of the symptoms list above, you should see your physician to be evaluated with a physical exam and further testing.

Currently, it is not possible to test for who is at risk of this disease - only for the presence of the condition.

Is BIA-ALCL a Major Concern?

All women planning to get breast implants should know that there is a risk of BIA-ALCL. Although uncommon, we want to make sure that our patients understand all associated risks before breast implant surgery. Of the 10+ million of women with breast implants worldwide, 595 cases have been reported. Among these, 16 patients have died. As more research is being done, doctors are better prepared to successfully detect, diagnose, and treat BIA-ALCL.

How Can I Decrease My Risk?

There are several decisions you can make that will help to decrease your risk of BIA-ALCL. These include:

Choosing smooth instead of textured implants
Getting regular follow-up evaluations
Performing monthly breast self-exams to check for any irregularities (this is recommended for all women to also check for signs of breast cancer)
Maintaining an open and communicative relationship with your plastic surgeon

Are Breast Implants Still Worth It?

The decision to get breast implants is a personal one, and as an elective procedure, should not be taken lightly. That said, although we know more now about the risk of BIA-ALCL than before, this risk is still small, and the FDA, as well the medical communities of ASPS and ASAPS, still consider breast implants to be safe and effective for both cosmetic and reconstructive cases.

Hundreds of thousands of patients each year opt for breast implants and report no adverse effects. When a possible association with a rare disease is reported, plastic surgeons follow the science to provide detailed, accurate information for full patient consent and decision making.

Breast implants are among the most studied medical devices in the world, and they will continue to be. Collaboration among the scientific community, patient advocacy groups and governments from around the world will continue to enhance the device and ensure the global plastic surgery community works together to keep all parties educated about the latest news and advancements to improve patient safety.

Many women find that the newfound confidence and self-esteem associated with getting breast implants still outweighs the risk - and as long as you commit to routinely monitoring yourself and consulting your doctor about any questionable symptoms, you should feel confident choosing to get breast implants.

If you have any questions, please feel free to call us at 870-333-5737. I’d be happy to answer any questions you have.