A. There have been 16 confirmed deaths, (globally), attributed to BIA-ALCL since the disease. was first reported nearly 20 years ago.

A: The first symptom of BIA-ALCL is usually a swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average 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. It can also present as a lump in the breast or armpit, firmness of the breast, or pain. It is usually easily and completely treated if patients see their doctor at the first symptom.

A: Based on current data, the risk can be explained by the texture grade of the implants as

• Grade 1 (Smooth only) – The current lifetime risk is zero.
• Grade 2 (e.g. Microtexture, Siltex and similar) – 1:82,000
• Grade 3 (e.g. Macrotexture, Biocell and similar) – 1:3,200

A: Most of the time patients see their plastic surgeon right away when they develop significant swelling of the breast. In these cases, the disease is almost always caught early and cured with a straightforward operation. Some women with advanced disease ignored earlier symptoms or saw a doctor who did not properly diagnose them. There are a few patients who presented with advanced disease who said that they never had earlier symptoms.

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.

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. Regardless of BIA-ALCL, all women should see their plastic surgeon immediately if they note a change to the size, feel, or shape of their breasts.

A: BIA-ALCL is only associated with textured surface implants so this is not relevant to patients considering smooth-walled breast implants. But patients considering textured breast implants should discuss this issue with their plastic surgeon. Since our knowledge of this condition is continuing to evolve, thanks in large part to ASERF-sponsored research, patients should check surgery.org and the FDA website for any updates.

A: The choice of implant type is ultimately a decision between an educated patient and her board-certified plastic surgeon. There may be certain circumstances where a textured implant is recommended for particular patients.

A: If a woman develops swelling in an augmented breast, she should undergo an ultrasound scan. If fluid is detected, it should be drained and tested for cytology. The majority of seromas seen clinically are benign seromas and not BIA-ALCL.

If a patient wants to have their textured implants removed and replaced, the options are:          

• Exchange to smooth implants with or without capsulectomy.

A: Current recommendations for the treatment of BIA-ALCL call for bilateral capsulectomy (removing all the scar tissue) and removal of the old breast implants. This is a very common procedure performed by plastic surgeons, Smooth implants can be put back in or the patient can choose not to have implants. In all early-stage cases, the disease has been fully resolved by this surgery alone. The majority of patients require no additional treatment. However, if the disease has spread to lymph nodes or grown into the adjacent tissues, chemotherapy and radiation may be necessary. These are very serious treatments with significant side effects.

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. Breast implant patients should have ongoing follow up. Current FDA recommendations and ASAPS recommendations indicate that patients with textured implants with no issues should not do anything and implant removal is not recommended.

A: There is no blood test to specifically screen for BIA-ALCL.

A: The best theory today is that a combination of four factors are required for the development of BIA-ALCL:

1. Textured implants
2. Chronic bacterial-inflammation
3. Genetic predisposition
4. Time

A: The available data does not support discontinuance of textured implants. The best practice is always for the physician to discuss with each patient the known risks and potential complications associated with any procedure. It is important for the patient and her doctor to frankly discuss all options available, and the risks involved.

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. The plastic surgeon must provide a frank and transparent discussion regarding the benefits and risks of implants, both smooth and textured. The patient must then make an informed decision, based upon her own assessment of her needs and the risks involved.

Every plastic surgeon needs to help each individual patient make her own decision about which implant she prefers in a fully transparent manner. This involves weighing any possible increased risks against the advantages offered by a particular type of implant. It is critical that the patient makes a fully informed decision following a full discussion of the risks and benefits.