Breast Implant Cases

Breast implants have been studied for more than two decades and very rarely produce side effects. However, the ASAPS and ASERF emphasize the importance of breast cancer screenings including self-exam, a regular physical exam, mammography, ultrasound and/or MRIs for breast implant patients. Past and current breast augmentation patients should also be aware of an uncommon condition called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

What is BIA-ALCL?

A rare spectrum of breast disease, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a condition that can range from indolent to full-blown metastatic disease when not caught early. BIA-ALCL is not a cancer of the breast tissue itself and is classified as a rare lymphoma. When diagnosed early, the disease is readily curable but can become more serious if it remains untreated. In such cases, chemotherapy or radiation may be required.

What are the physical symptoms of BIA-ALCL?

Typically, the first symptom of BIA-ALCL is swelling of the breast. This occurs between 2 to 28 years after surgery, with an average timeline of 8 years. Causing the breast to enlarge significantly over a period of days or weeks, swelling is due to a collection of fluid surrounding the implant.

The disease can also appear as a lump in the breast or armpit area, chest pain, redness or change in firmness around one or both implants. If you are experiencing any of the listed side effects or are feeling general discomfort, you should visit your physician immediately. All women should see their plastic surgeon immediately if they note a change to the size, feel or shape of their breasts. If this is the case, you should visit your physician to ensure your breast implants are still intact.

What causes BIA-ALCL?

Although the condition has only been documented in textured implants, no specific causal factors have been identified to date. The best theory is that a combination of three factors is required for the development of BIA- ALCL: a highly textured implant, chronic bacterial-inflammation, and genetic predisposition.

The source of chronic inflammation stems from bacteria that forms around the implant. Evidence is accumulating that a long-term inflammatory response to the presence of these bacteria is one of the main factors that cause BIA-ALCL. A few cases from different geographic areas have reported genetic determinants to also play a role. Ongoing data collection worldwide will help to determine whether or not there are any genetic propensities for this disease.

Does the filling of an implant play a role?

Of the 414 reported cases of BIA-ALCL, 312 reports included information on the types of implants used. Of those reports, 234 cases noted silicone gel implants while 119 reported being filled with saline. Still, the condition appears to purely be related to the surface of the implant and not to what the implant is filled with.

What is the risk of developing BIA-ALCL?

Based on current data, the risk can be explained by the texture grade of the implants. Smooth implants have a current lifetime risk of zero, while textured implants have varying risk. They are as follows:

  • Grade 2 (e.g. Microtexture, Siltex and similar) – 1:82,000
  • Grade 3 (e.g. Macrotexture, Biocell and similar) – 1:3,200
  • Grade 4 (e.g. Polyurethane) – 1:2,800

Have there been any deaths due to BIA-ALCL?

There have been 16 confirmed deaths globally since the disease was first reported nearly 20 years ago.

Other than observing physical symptoms, is there another way for me to assess if I’ve obtained BIA-ACL?

When receiving saline or silicone implants, it is generally a good idea to conduct ongoing surveillance of your implants; this includes monitoring physical reactions as well as conducting self-breast exams and mammograms scheduled through your physician. It’s important to note that an MRI is not a suitable substitute for a mammogram. While an MRI can detect breast cancer, it cannot diagnose BIA-ACL. Blood tests also can’t specifically screen for BIA-ALCL.

The only reliable assessment is if after conducting an exam, fluid is found around the implant, the fluid should be aspirated under ultrasound guidance and sent for proper analysis.

Why would my surgeon have recommended textured implants?

Every plastic surgeon offers patients options regarding breast implants in terms of sizing, shape, and surface. Depending on a particular patient's needs, a textured implant may be preferable.

There are two primary reasons your surgeon may have recommended textured surface breast implants. First is that some data has shown a lower rate of capsular contracture; that is, the firm scar tissue formation around the implant. 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.

Plastic surgeons must provide a frank and transparent discussion regarding the benefits and risks of implants, both smooth and textured. It’s then up to the patient to make an informed decision, based upon her own assessment of needs and the risks involved.

How is BIA-ALCL treated?

When detected early before it becomes a lymphoma, BIA-ALCL is readily cured by removing the implant and surrounding scar pocket or capsule. Current recommendations for the treatment of BIA-ALCL call for bilateral capsulectomy; that is, the removal of all scar tissue and old breast implants. This is a very common procedure performed by plastic surgeons and is identical to the prognosis when an implant has ruptured or capsular contracture has developed.

Following bilateral capsulectomy, smooth implants can be put in or the patient can choose to not have implants altogether. In all but a few cases, the disease has been fully resolved by this surgery alone and the majority of patients require no additional treatment. However, if the disease has spread to the lymph nodes or adjacent tissues, chemotherapy or radiation may be necessary. This has only been necessary for a small percentage of patients.

Should I have my implants removed because of a risk of BIA-ALCL?

Since BIA-ALCL has only been found with textured breast implants, smooth implant patients should not be concerned. As far as textured implant patients, neither the FDA nor any plastic surgery society currently recommends that women preventatively remove textured breast implants to protect themselves against developing BIA-ALCL. However, there are women who have been concerned enough about BIA-ALCL and have chosen to have their implants removed by their own accord. There are some women who have considered a breast implant revision, and the BIA-ALCL issue simply provided another reason to proceed with the removal.

Does the ASAPS recommend against the use of textured implants?

Currently available data does not support the discontinuance of textured implants. The best practice is always for the physician to discuss the known risks and potential complications associated with any procedure to equip their individual patients with the right knowledge to decide.  

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The Aesthetic Surgery Education and Research Foundation (ASERF) funds important research that directly impacts the clinical practice of aesthetic surgery. Their mission is to identify and purpose those issues relevant to advancing the safety and effectiveness of aesthetic medicine through independent, unbiased, directed research and groundbreaking education. In regard to BIA-ALCL, the foundation is sponsoring leading, cutting edge research to better define the disease as well as improve diagnosis and outcome.

The American Society for Aesthetic Plastic Surgery (ASAPS) is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 plastic surgeons. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.