Allergan global textured breast implant and tissue expander recall (Biocell)
The Food and Drug Administration (FDA) requested today (25th of July, 2019) that Allergan recall its textured breast implants and tissue expanders in the USA. This has led to Allergan instituting a voluntary global recall of all its textured breast implants and tissue expanders. They had already been withdrawn from the market in France since January of this year.
The reason is that out of the BIA-ALCL cases, the vast majority have been Allergan textured (otherwise known as Biocell) implants.
There are currently worldwide a total of 573 BIA-ALCL cases and 33 patient deaths.
481 out of the 573 are reported to have Allergan textured implants at the time of diagnosis.
12 out of 13 deaths as a result of BIA-ALCL where the implant brand was known were Allergan breast implants .
It is important to note that in the remaining deaths the device was unknown.
The difficulty in getting accurate statistics for this cancer stems from the fact that in quite a large number of cases, the device that caused the cancer is not known, In other cases, patients may have had a number of different brands and types of implants, which makes it hard to know which one actually caused the cancer.
Here is a link to the current statistics on total number of BIA-ALCL cases and deaths and their breakdown according to implant brand.
Not all textured implants are the same
Other textured implant brands have very low rates of BIA-ALCL.
Each implant company has a slightly different type of texturing. When assessing the risk of a device, it is important to examine the number of cases a particular brand has had.
Textured implants have continued to be used as they present significant advantages in certain patients.
Polyurethane coated implants have been considered in certain studies as macrotextured. In fact, according to the current data, Polytech polyurethane implants manufactured in Germany carry the lowest risk with a rate of 2 per 400 000.
“It is important to note that there are other polyurethane implants on the market, specifically the Polytech polyurethane implant that currently has two cases of BIA-ALCL with over 400,000 implanted implants. The difference is that Polytech implants behave far differently in the body, with very predictable soft-tissue integration into the polyurethane surface that not only decreases the chance for bacterial growth, as there is no “dead space,” but also may have some antibacterial biochemical effects as the polyurethane degrades. In the case of the Polytech polyurethane implants, two in 400,000 is actually the lowest incidence currently known for any textured implant on the market.” (as quoted by Adams et al Plastic and reconstructive surgery, May 2019). Despite this published evidence the TGA instituted a 6 month suspension on these implants commencing on the 25th of October, 2019. It is important to note the company will still have available their microtextured implants, which are the only company to give a 10 year warranty against capsular contracture (as well as a lifetime warranty against rupture). Although this is less than the 15 year warranty available for their polyurethane device, it is still superior to other models on the market and something to consider when selecting a device.
Smooth implants- do they present a lower risk of BIA-ALCL?
Smooth implants have been thought to carry the lowest risk of BIA-ALCL.
Smooth implants often give a poorer cosmetic result, especially in revision cases, and carry a higher risk of capsular contracture.
In the 26 cases of patients who had BIA-ALCL and smooth implants, 12 had an unknown prior history of implants, 7 had a history of textured implants, and 7 had a history of prior implants with an unknown surface.
There are no reports of BIA-ALCL cases associated with tissue expanders.
There has been one apparent case with a buttock implant.
The textured breast implant situation in Australia-update as of 26th of September, 2019.
The list of implants that are no longer available as of the 26th of October, 2019 are in this link to the TGA while they are subject to review for a further six months. Others have had conditions imposed.
It is important to note that a suspension on implants does not mean that there should be cause for panic in those that have them in place. Overall the numbers are extremely low. Some of the implant brands suspended have been removed as a precaution rather than that they present an overwhelming greater risk than others; rather they may not be in as statistically widespread use in Australia. This does not mean they are a lesser device or require removal in the absence of symptoms which are detailed below. Many plastic surgeons in Europe continue to use some of these devices.
It is important to note the FDA removed silicon implants in the 1990s for several years in the United states until evidence to their safety was presented, and they continued to be used in Australia and Europe during this time.
Conversely, the device currently responsible for the most cases worldwide was one of the most widely used and popular devices 10 years ago and considered safe based on the evidence available then. There is still much that is not known about BIA-ALCL. No device is without risk, and we only can make decisions based on the best available evidence at the time. It is important to note that some of the remaining devices that will be available have had no cases, however, may not have been around long enough for the lag time of 7-10 years for the disease to develop.
Patients wanting breast implants still need to accept a small risk, no matter which implant they choose. For those not willing to risk a very rare change of BIA-ALCL, a breast implant is not the best decision for them.
Monitoring breast implants that have been inserted is key
There should be no current cause for panic for women who have textured breast implants that have not changed since their insertion and feel and look normal.
If there is any change in your breast implants or you are unsure if anything has changed, make sure you get investigated by your surgeon and that imaging is organised.
The vast majority of cases present with a fluid collection around the implant (seroma), intermittent swelling or a mass.
Even if a patient is unlucky enough to get BIA-ALCL, it is curable in over 90% of cases.
Remember, having a breast implant removal and total capsulectomy for an implant that is not causing a problem and is very unlikely to cause a problem may lead to a very unsatisfactory result. Breast implants can be replaced with a fat graft, however, surgery to achieve the same volume results will involve more than one surgery and requires adequate fat stores.
It is up to the individual if they are comfortable leaving a device in or having one inserted in the future with a rare chance of cancer. As with many devices, it can take many more years to get a complete and accurate idea of risk and the exact cause of this rare form of cancer.
Putting the risk and statistics into perspective
It is not recommended that asymptomatic patients should have removal of their textured implants, even if they are the highest risk ones.
Overall the risk is still very low. For some people, to have any kind of cancer risk with a cosmetic device is unacceptable. For other people, textured breast implants either for reconstructive or cosmetic purposes greatly improve their quality of life, and they may be willing to accept the small risk of a very rare cancer.
1 in 8 women will get breast cancer in their lifetime.
The risk of breast implant associated cancer is 1 in a few thousand to a several hundred thousand, depending on the brand of implant.
This blog will continue to be updated as more information comes to light.
Please email [email protected] if you have any concerns about your implants. For existing patients of Dr Simone Matousek, you are welcome to attend a follow up consultation at any time free of charge to be examined and discuss any concerns, free of charge.