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What does the Allergan Implant Debacle (BIA-ALCL) Mean For Sientra?


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It is hard to imagine that breast implants could cause cancer. It is even harder to imagine that they can cause other symptoms such as alopecia, fogginess, irritable bowel syndrome, pain, and migraines.

Well, there has been a slow and steady build-up of evidence that suggests that specific type of breast implants – textured – can increase the risk of a specific rare form of cancer. Use of textured implants has been shown to be associated with a form of cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Concerns were first raised as early as the 2010s, with a paper published in the Journal of Plastic and Reconstructive Surgery by Dr. E. Hall-Findlay highlighting findings specific to capsular breast implants such as double capsules and late seromas.

By 2013 – 2014 [1] [2] [3] we began to see studies published that began to shed light on the use of aggressively textured implants and their association with BIA-ALCL. Research continues to support the notion that BIA-ALCL is associated with textured implants [4] [5] [6], and as physicians became comfortable with correctly diagnosing BIA-ALCL, there appears to be an increasing number of overall reported cases [7] [8].

Now, it is imperative to note that BIA-ALCL is rare. In 2015 there were 173 confirmed cases out of the 364,000 patients having undergone breast augmentation and reconstruction. It has been reported that the risk of developing BIA-ALCL is about 0.003% (about 1 in 30,000), the risk of BIA-ALCL with lymph node metastasis is about 0.0004%(1 in 250,000) and the risk of developing BIA-ALCL which is not resolved in 3 years is approximately 0.0002% (1 in 500,000) [9]. In Canada, the reported rate of occurrence of BIA-ALCL is one in 24,177 or 0.0041% [10]. Now, this number may be higher and even a single case is unacceptable.

Katherine Smylie, from Edmonton, who had her Biocell textured breast implants removed after experiencing pain. (Rod Maldaner/CBC)

Perhaps, the 47-year-old Edmonton woman who was recently featured in several news articles is a rare case, however, no one who has undergone a double mastectomy – for the eradication of risk of breast cancer – should then develop breast cancer due to the implants. However, this news was accompanied by others like her, such as the 44-year-old Terri McGregor, who ultimately required eight rounds of chemotherapy after doctors discovered that not only had her implants ruptured, but they had also provided grounds for cancer to metastasize from her capsule to lymph nodes and abdomen.

Initially, Ms. McGregor was notified that she did not have long to live. Subsequently, she filed for a civil lawsuit against Allergan stating that Allergen did not fully inform her of “all the dangers inherent in the use of its products that it knew or ought to have known.” Furthermore, she stated that had she been informed of the risks of developing BIA-ALCL after undergoing her breast augmentation, she would have taken the steps necessary to have them removed.

 

What could cause Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)?

There have been various hypothesis presented that present a viable explanation as though what can lead to the development of BIA-ALCL. Deva et al published an article suggesting that the BIA-ALCL could be attributed to the biofilm that develops over the breasts after implantation [11]. This biofilm then triggers an inflammatory reaction which then causes an immune response.

The presence of gram-negative bacteria (i.e. Pseudomonas, Ralstonia Picketii, Brevundimonas) and its biofilm have been attributed to increased risk of BIA-ALCL. It has been suggested that the biofilm causes an over-activation of the lymphocytes and promotes their transformation inducing lymphoma [12]. Interestingly, the gram-negative bacteria Ralstonia Picketii has been most commonly implicated in cases of BIA-ALCL.

Furthermore, several authors have also suggested a component of the extent of the textured surfaces and a correlation with developing BIA-ALCL. Studies have suggested that textured implants also lead to an increased inflammatory reaction, leading to increased immune response and thus increased the risk of developing BIA-ALCL [13]. Lastly, it appears that there is a geographical and genetic correlation with developing BIA-ALCL as well [14].

 

Textured versus Smooth Implants? Which is better?

BIA-ALCL reports grouped by implant surface (numbers provided on February 21, 2017, FDA update) (based on cases reported to the MAUDE Database).

The number of reported cases to the FDA of patients who developed signs and symptoms of BIA-ALCL as of February 21, 2017, are as follows, Textured: 203, Smooth: 28 and Unknown: 128. It is important to note that these are the “reported cases” and that it would be safe to assume that there would be a lot of unreported cases as well.

Smooth implants are generally used due to their safety profile. However, compared to the smooth, the textured implants have been shown to have an improved benefit in reducing the incidence of capsular contracture, as indicated by a meta-analysis published in 2015 [15]. Capsular contracture is the leading cause of morbidity and reoperation in patients following breast reconstruction [16].

Tables below highlight the benefits, limitations and patient selection considerations when looking at using smooth versus textured implants.

Smooth Round Silicone Implants: Benefits, Limitations, and Patient Selection Considerations

Textured (Round and Shaped) Silicone Implants: Benefits, Limitations, and Patient Selection Considerations

Not all Textured Implants are alike

Each manufacturer creates a specific microenvironment that sets the foundation for their textured implants. These microenvironments are essential for providing the foundation for which the specific cells of the body can use to integrate this foreign object into the body.

Naturally, the more the texture the higher the resistance to movement through friction. As stated above, each manufacturer has a different method of creating this texture. Mentor uses a negative contact imprinting in addition to polyurethane foam. Sientra uses volatilization of ammonium carbonate with heat, while Allergan uses calibrated sodium chloride crystals (salt) which are then rinsed, washed, soaked, and scrubbed after curing. The difference in these microenvironments can be seen in the figure below.

Scanning electron microscopic (SEM) images of (A) Mentor, (B) Sientra, and (C) Allergan textured surfaces at 65× magnification. SEM is the industry standard to characterize the combination of shell surface disruption and pores promoting tissue adherence to the textured shell surface.

You can certainly appreciate the differences in the textured implants created as a result of different processes. Mentor has the least aggressive texture, however, it lacks the adherence compared to the other two. Sientra has a moderately aggressive texture which resists movement through friction and adherence is rare.

Summary of BIA-ALCL reports submitted to FDA’s MAUDE database by the manufacturer as of September 10, 2015.

In the case of Allergan, they have the most aggressive texture (macrotexture). It has the highest stability and the lowest implant mobility. It has been shown to adhere to the surrounding tissue creating what the have described as a “Velcro effect”. [17] [18]

It may be unfair to Allergan, however, data is pointing to the fact that their aggressive texture may be attributed to increased risk of developing BIA-ALCL. In fact, according to the FDA’s MAUDE database as of September 2015, the majority of the reported cases of BIA-ALCL were attributed to Allergen implants.

 

 

What does this all mean for Sientra Inc.?

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Dr. Tiam Feridooni

Written by: Dr. Tiam Feridooni MD, PhD, BSc Dr. Feridooni, graduated from Dalhousie Medical School in May, 2018. Prior to enrolling in medical school, he completed his Bachelor of Science with Honours in 2010 in Biochemistry. He then obtained his PhD at Dalhousie University in Pharmacology in 2014, with a focus around regenerative medicine and stem cell transplantation. Dr. Feridooni has been published numerous high impact journals and has also co-authored a few books.

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