In March of 2017 I wrote a blog to help explain a news article that came out about BIA-ALCL. Since then, more information has become available, and the recall of Allergan’s Biocell implants has prompted an update.
BIA-ALCL is a rare type of cancer that develops in the scar tissue around breast implants. Worldwide there have been 573 confirmed cases collected since 1997, with 33 deaths, but only 21 were due to the disease. While implant information is not available in many of these cases (around 20%), there does appear to be a strong correlation with textured surfaces, and one company (Allergan) in particular.
Allergan has recalled their textured Biocell implants from the market. This type of texturing has also been used in McGhan and Inamed implants (same implants, different company names). This recall is for implants sitting on shelves, not implants that reside in patients. The FDA does not recommend removing implants from asymptomatic patients. If you have these implants and want them replaced, it is good to discuss the pro’s and con’s because the risk of removal may outweigh the benefits of removal. Breast implants are not considered lifetime devices, and if there are other reasons to have revision surgery, it may be worthwhile.
Why does BIA-ALCL form?
It is believed that BIA-ALCL is a form of inflammation that undergoes a malignant change. A perfect storm of a rough implant surface, certain uncommon bacteria living on the implant, and a genetic predisposition to the disease is what leads to this problem. Patients with smooth implants have been diagnosed with BIA-ALCL, but they had textured implants in the past. There have been no confirmed cases of smooth implants only.
It is estimated that there are over 35 million women in the world with textured implants. The majority of patients diagnosed with BIA-ALCL (481) had Allergan Biocell implants. There is no question that the number diagnosed with BIA-ALCL will grow with more knowledge of the disease, but this is still considered very rare. This is also a very treatable form of cancer, with the vast majority being cured by removing the implants and scar tissue capsule alone. Smooth implants or other forms of reconstruction have not been shown to negatively effect outcomes.
Early on it was not known how to best treat patients, and unfortunately many of the deaths were due to a delay in diagnosis, incomplete removal of the capsule, or complications from chemotherapy that might not have been appropriate but the best guess at the time. Currently 93% of patients are disease free at 3 years.
- The highest risk of BIA-ALCL is with Silimed polyurethane implants (estimated at 1 in 2,832). Polyurethane implants have not been available in the US since 1991.
- Texturing using a salt loss technique referred to as Biocell (used in Allergan, Inamed, and McGhan implants) has a risk of 1 in 3,817.
- Siltex imprint texturing used in Mentor implants is estimated at 1 in 60,631.
- Gas expansion True Texture used in Sientra brand implants is 1 in 160,000.
In addition to the association of BIA-ALCL with the textured surface, there is also believed to be a genetic mutation in patients that pre-disposes them to developing the disease. Studies in Australia and New Zealand show a higher risk, while reports from Asian countries are extremely low, so there is likely an ethnic and genetic component.
Bacterial contamination of implants (called a bacterial biofilm) is common with foreign bodies, including breast implants. What has been unusual in patients with BIA-ALCL is more gram negative bacteria found as opposed to gram positive bacteria that normally reside on the skin and are more commonly found on breast implants. It is felt that this “perfect storm” of a genetically predisposed patient, unique bacterial contamination, and chronic irritation from a particularly rough surface found in some breast implants may lead to the progression of inflammation that undergoes a malignant change after many years (typically at around a decade, ranging from1-37 years).
In my career I have used both smooth and textured implants, and exclusively textured tissue expanders that were from Allergan, the company issuing the recall. With the exception of just a few patients undergoing breast reconstruction the final implants that I used were smooth implants. To date there has not been a case of textured tissue expanders and smooth implants that has gone on to develop BIA-ALCL.
Symptoms of BIA-ALCL
The most common presenting symptom is swelling or enlargement of a breast due to fluid around the implant called a seroma. This could be painless or associated with discomfort, redness, or itching. The diagnosis of a seroma can be made with an ultrasound or MRI. Most late seromas, which occur after the breast is healed from initial surgery, are benign (not cancer). A diagnosis is made by aspirating or drawing up the fluid and sending that fluid for special testing which will determine if there are distinct markers associated with BIA-ALCL. Most patients with BIA-ALCL have had their implants for close to a decade before symptoms arise.
Patients may also present with a breast mass. A breast mass will typically raise concern for any woman, regardless of whether they have implants or not, so an appropriate work up will ensue.
Capsular contracture or tightening of the scar tissue around an implant can occur in anywhere from 13% to 50% of all patients with breast implants. A new onset capsular contracture is more commonly a benign process, but patients should see their plastic surgeon for an evaluation.
Most patients 40 and older receive routine breast cancer screening with mammography and breast exams. Unfortunately, mammography is not a good diagnostic tool to detect BIA-ALCL. Ultrasounds, commonly used to evaluate dense breasts, masses, and implant integrity, are a good tool for helping to diagnose BIA-ALCL. The FDA also recently issued that it is an acceptable study for looking for implant ruptures, as opposed to more expensive MRIs. An MRI without contrast is used to assess implant integrity, and also would show fluid collections around implants. MRI’s with contrast are the most sensitive way of looking for breast cancer. Both Ultrasounds and MRI’s are acceptable in looking for signs of BIA-ALCL in addition to physical exams.
What are textured implants?
Textured implants were designed initially to decrease the risk of capsular contracture, or tightening of the scar tissue around breast implants. A textured surface to the implant also allows for anatomic or teardrop shaped implants because the rough surface maintains the appropriate orientation. Anatomic implants have been available outside the US since the 1990’s and were approved by the FDA for use in the US in 2012.
There are 3 breast implant companies in the US, and each has it’s own proprietary form of texturing. It has become clear that there is a not only an association with BIA-ALCL and texturing, but also with the type of texturing.
Allergan creates their textured surface by forming the silicone rubber shell around salt crystals that are then washed away. This creates a very rough surface, and the tissue healing around the implant creates a Velcro like attachment to the implant, which helps keep implants from moving or sliding, which is common with smooth implants. Their anatomic implants (known as 410’s) are also very firm and can fight strong muscle contraction. The company’s name for their texturing is Biocell.
Mentor implants use a different technique to create their Siltex textured implants. An imprint is made on the silicone much like a cobblestone pattern. This type of texturing does not allow for tissue ingrowth, so these implants can slide and drop much like the smooth implants. Their anatomic implants are held in place with a tailored pocket and traction, much like skateboard tape.
Sientra True Texture is created by gas expansion or air bubbles on the surface of the implant. These allow for some tissue ingrowth to help hold implants in place, but are less aggressively textured and rough than the Allergan implants.
There are times that I feel textured implants provide superior results to smooth implants. First, the anatomic shapes are desirable to patients who want a very natural shape to their breasts. Patients wanting to maintain more upper pole volume and less dropping of the implants may prefer textured implants. The two scenarios where I think textured provide superior results are those undergoing a mastopexy with their augmentation, and when moving implants from above to below the muscle.
Outside of the United States textured implants were used anywhere from 70-90% of the time depending on the country. They also have many other companies and types of implants including polyurethane foam covered implants that were removed from the US market in the 1990’s. Inside the US textured implants are used less commonly, closer to 10-15% of the time.
Just to provide a frame of reference the American Cancer Society estimates that 1 in 3 Americans will be diagnosed with cancer in their lifetime. About 1 in 5 will die from cancer, with the numbers being a little better for women than men.
For breast cancer specifically 1 in 8 women will be diagnosed in their lifetime (and I was just told that new numbers for Colorado are 1 in 7). Unfortunately, 1 in 38 women will die of breast cancer. It is estimated that in 2019 alone there will be 268,000 new cases of breast cancer diagnosed in the US, and 62,930 deaths. Currently there are more that 3.1 million women in the US living with breast cancer.
Most women begin mammographic screening between 35 and 44 years of age and get them every 1-2 years based on risk. Additional studies like Ultrasounds and MRIs are also performed in certain patients based on their history and tissue characteristics. The value of self-breast exams is controversial, but I highly recommend them.
BIA-ALCL is not breast cancer. It is a rare type of lymphoma that starts in the capsule or scar tissue around breast implants. Mammograms, which are very helpful in screening for breast cancer, do not help diagnose BIA-ALCL.
Lymphoma is broadly defined as a cancer starting from the body’s immune cells. There are 2 main categories (Hodgkin’s and Non-Hodgkin’s) based on the type of cell the cancer originates from. Your lifetime risk of getting Non-Hodgkin’s lymphoma (NHL) is 1 in 42 for men, and 1 in 54 for women. The risk of dying from NHL is 1 in119 for men and 1 in 152 women. In 2019 it is estimated that there will be 1130 cases of NHL in Colorado with 250 deaths.
Anaplastic Large Cell Lymphoma (ALCL) is a rare subset of NHL and accounts for only 2% of lymphomas with about 1,400 cases diagnosed in the US every year. The World Health Organization first recognized this type of lymphoma in 1985.
There are 3 different kinds of ALCL:
Primary Cutaneous ALCL (pcALCL) starts on the skin, has a 10-year survival rate of greater than 90%. They are generally treated with excision or radiation and about 1 in 4 of these will resolve spontaneously. The majority of BIA-ALCL cases have similarities to this type lymphoma
Systemic ALCL is the second form and tumors generally occur in organs. This form of ALCL has a much worse prognosis with a 5-year survival of only 40-60%. This type of lymphoma can occur in the breast, but it is rare. In 2008 a researcher in the Netherlands was studying Non-Hodgkin’s Lymphoma (NHL) of the breast, which only accounts for about .4-.5% of all breast malignancies. She followed 389 patients and found there were 11 patients with ALCL. ALCL was extremely rare (about 3 per 100 million per year, with a 75% mortality rate.). It was interesting that in these 11 patients 5 of them had breast implants (of note in the Netherlands the vast majority of implants used were textured, and all of these patients had textured implants). As these studies continued over the next decade the number of ALCL patients grew, as did the percentage of patients with breast implants. What was subsequently found to be different about these patients was that instead of the lymphoma being in the breast tissue, it was starting within the capsule (scar tissue) around the implant or adjacent to the capsule, not in the breast tissue. This subgroup then became a distinct third type of recognized ALCL.
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is the third form of ALCL and it has more similarities to the milder primary cutaneous ALCL. It occurs around breast implants, most commonly around textured implants or in patients with a history of textured breast implants. BIA-ALCL as a distinct entity was recognized in 2016. BIA-ALCL most resembles Primary Cutaneous ALCL, but there have been cases that are particularly more aggressive in nature.
BIA-ALCL is a type of lymphoma that develops in the scar tissue around breast implants, with the highest incidence around polyurethane (not available in the US) and Allergan Biocell implants, which have just been removed from the market.
- Presenting symptoms are breast swelling with or without pain, breast mass, redness, lymph node swelling, or capsular contracture.
- There have not been documented cases with smooth implants only, but have been cases in patients currently with smooth who had textured in the past.
- Patients with textured implants should be aware of symptoms, can add ultrasounds into their normal implant screening, and do not need surgery to remove or replace their implants unless there is some other reason they are seeking a revision.
- Remember that 1 in 8 women are diagnosed with breast cancer, and one in 38 will unfortunately die of the disease.
- 1 in 54 women will be diagnosed with Non-Hodgkin’s Lymphoma, and 1 in 152 will die of the disease.
- The type of textured implant matters with the highest number of cases coming from Polyurethane (1 in 2,832) and Biocell (1 in 3,817). Less aggressively textured implants have lower rates including Mentor Siltex (1 in 60,631), and Sientra (1 in 160,000).
- The number of patients diagnosed with BIA-ALCL will go up as it is now a recognized entity and there are international databases for reporting.
- The prognosis of BIA-ALCL is very good, with 93% disease free (considered cured) at 3 years.