Breast Implant Associated ALCL

Women considering breast augmentation, or those who already have breast implants, may have read or heard about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). BIA-ALCL is a rare illness linked to certain implants, which have been the subject of many news stories and discussions on social media. The condition has been researched extensively and Dr. Mosher wants to ensure our patients are fully informed about the remote risk of BIA-ALCL when considering breast augmentation.

Based on clinical information provided by the American and Canadian Societies for Aesthetic Plastic Surgery, we’ve created this page and one about BII to help answer your questions.

Frequently Asked Questions

Q: What is BIA-ALCL?

A: BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is a rare spectrum of disorders that can range from a benign collection of fluids around the breast implant (seroma) to a rare lymphoma. BIA-ALCL is not a cancer of the breast tissue itself. When caught early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required.

Q: What are the symptoms of BIA-ALCL?

A: The first symptom of BIA-ALCL is usually a visible swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average onset of about 8 years after implantation. The swelling is due to a collection of fluid surrounding the implant. This fluid can cause the breast to enlarge significantly over a period of days or weeks. BIA-ALCL can also present as a lump in the breast or armpit, a change in the firmness of the breast, or pain. These same symptoms more commonly occur with benign disease in patients with breast implants. The disease  is usually treated successfully if patients see their doctor the first sign or symptom developing.

Q: What is the risk of developing BIA-ALCL?

A: Worldwide, all cases of BIA-ALCL have involved the use of textured surface implants made by a variety of companies. In Canada, two implant manufacturers were approved to sell textured breast implants. Both have have been associated with documented cases of  BIA-ALCL. Based on current data, the risk can be stratified by the texture grade of the implants as follows:

  • Grade 1 (Smooth only) – The current lifetime risk is considered to be zero.
  • 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*

Q. Have there been any deaths due to BIA-ALCL?

A. There have been a few confirmed deathss, (globally), attributed to BIA-ALCL since the disease was first reported nearly 20 years ago. Current protocols for treatment of BIA-ALCL have resulted in a high degree of success and possible long term cure. If diagnosis is delayed, then BIA-ALCL can spread outside of the breast and the prognosis becomes more guarded.

Q: Does BIA-ALCL occur with Saline or Silicone implants?

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

Q: How does this impact those with breast implants?

A: ASAPS and ASERF emphasize that the most important issue for women with breast implants is to screen for breast cancer with self-exam, a regular physician exam, and mammography/ultrasound/MRI as recommended by their physician. All women should see their plastic surgeon immediately if they note a change to the size, feel, or shape of their breasts.

Q: Why would my surgeon have recommended textured implants for me?

A: Worldwide, textured surface breast implants have been the most commonly recommended by Plastic Surgeons. Some studies indicate that texturing on the implant surface reduced some implant related complications compared to smooth surfaced implants. This benefit was thought to be more helpful for some patient situations than others. Textured and smooth implants have been approved for use in Canada for more than 30 years. Furthermore, anatomically shaped or “tear drop” shaped devices are only manufactured with a textured surface. For many years and prior to our current understanding about BIA-ALCL, textured implants were recommended for about 40% of Dr. Mosher’s cosmetic breast enhancement patients. Although textured implants remain available in Canada, we no longer recommend these devices.

Q. How is BIA-ALCL treated and what is the prognosis?

A: Similar to the management of other malignancies, treatment protocols have been established for this disease. Prior to treatment, all patients with BIA-ALCL undergo a thorough assessment to help establish the “stage” of their disease. When confined to the space around the breast implants or the adjacent breast implant capsule – removal of the implant and capsule on both sides is recommended. For these patients diagnosed early, all but a few have been fully resolved by this surgery. However for higher stage of disease, there the lymphoma affects tissues at a distance from the breast, chemotherapy or radiation therapy may be recommended. Approximately 15% of patients have this more advanced disease at the time of their initial diagnosis.

Q. Should patients have their implants removed because of a risk of BIA-ALCL?

A: Since BIA-ALCL has only been found with textured breast implants, smooth implant patients do not need to be concerned. For textured implant patients, neither the FDA nor any plastic surgery society currently recommends that women should preventatively remove textured breast implants to prevent BIA-ALCL. However, there are women who have been concerned enough about BIA-ALCL and have chosen to have their implants removed. There are some women who were already considering a breast implant revision, and the BIA-ALCL issue gave them one more reason to decide to proceed.

Q: Should women with breast implants be screened for BIA-ALCL?

A: There is no blood test to specifically screen for BIA-ALCL. The expert opinion is that asymptomatic women without breast changes do not require more than routine mammograms and breast exams. But if a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo immediate examination, imaging, and consultation with a plastic surgeon. If there is fluid around the implant the fluid should be aspirated under ultrasound guidance and sent for analysis.

Q: What causes BIA-ALCL?

A: Many different medical organizations and the implant manufacturers are intensely studying BIA-ALCL. To date, no specific causal factors have been identified. Implant texturing, bacteriologic contamination and genetic factors have been implicated and are undergoing further study. The best available information is that a combination of four factors are required for the development of BIA-ALCL

1. Texturing of the implant

2. Chronic bacterial-inflammation around the implant

3. Genetic pre-disposition (specifics are not yet determined)

4. Time (2 or more years are required)

These factors seem to have a common role in many forms of non-hodgkins lymphoma. Data collection and research is ongoing

Q: Does Dr. Mosher recommend against the use of textured implants?

A: Although Health Canada and other regulatory agencies around the world continue to approve the use of some textured breast implants, until we know more, Dr. Mosher does not recommended textured breast implants for cosmetic breast surgery.  Using smooth breast implants still allows for a high degree of patient satisfaction as well as a customized approach.

Q: Is the removal of textured implants covered by insurance?

A: At the present time, Provincial medical coverage does not cover the costs associated with the removal of textured breast implants. As the scientific information evolves, Provincial policy may change. For patients with Allergan (Biocell) textured breast implants, replacement smooth Allergan implants of a similar size may be provided by the manufacturer at no charge to the patient.

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