PIP Q&A prepared by Mr Alex Karidis, January 2011
Please find below a Q&A I have prepared which I hope will answer some of the questions you may have regarding PIP implants. Myself and my team are doing all we can to speak with all patients affected and to offer reassurance and advice.
If after reading this Q&A you have any additional questions, please do not hesitate to contact a member of the Karidis team.
Mr. Alex Karidis
When was the PIP implant problem discovered?
In March 2010 the French regulator Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), discovered that the PIP manufacturer had been using industrial grade silicone instead of the medical grade specified for the CE mark. AFSSAPS revoked the CE mark and the MHRA promptly issued a medical device alert to all UK clinicians and cosmetic surgery providers, asking them to cease using the implants.
Was the problem related to a manufacturing defect or oversight?
Neither. There was criminal fraud that took place at the manufacturers. The PIP manufacturer intentionally replaced the intended medical grade silicone that was originally used for the manufacture of these implants with an in house developed non medical grade silicone in order to increase profits. By most accounts available, it appears that this process began sometime in 2001. As a result of this observation, it is implied that prior to this time the silicone that had been used was of the medical grade type. It is also not clear whether it was some or all the batches of silicone implants had the non medical grade type silicone inserted.
Why wasn’t this picked up by the regulators?
PIP received a CE mark for their silicone gel breast implants via the German Notified Body TUV Rheinland. The MHRA( Medicines and Healthcare products Regulatory Agency) in the UK also approved the marketing of these implants in the UK. It has been said that checks were performed by the German TUV intermittently-however PIP were usually notified about 2 weeks prior to them coming. Unfortunately it is very clear a catastrophic failure of the regulator services has occured in both this country and the EU, leading to this act of criminal fraud.
I have heard that these implants were considered “cheap” because they were so inexpensive to buy. Is this true?
The reality is that when these implants were originally marketed in the late 1990’s and at the time their price was very similar to other implant manufacturers.
The origins of these “cheap” references are made almost exclusively to people buying the PIP implants in the last 3 years prior to them becoming banned, i.e from 2007 onwards. As I have already stated I stopped using PIP implants in the first half of 2006. In addition to myself, I am aware that around the same time several other surgeons eventually stopped using the PIP implants as well. As a result of the ensuing substantial loss of market share, it is believed both the manufacturer and importer started an aggressive pricing policy to lure new business. This culminated in a massive drop in the pricing of their implants, which some clinics of course saw as enticing, leading to new and increased business sales for PIP. Although this does make a case for the theme that in these circumstances some of the clinics should have known better, ultimately they did not do anything illegal by purchasing a “cheaper” product as the product had a CE mark, it should, in the very least, have been safe.
Why did Mr. Karidis use these implants in the first place and why did he stop?
I started using PIP implants in 1998, well before this fraud started to occur. The reason I started using them is because I liked the type of texturing the outer shell provided as well as the cohesive qualities of the silicone gel. I continued to use them because they seemed to perform very well.
When I refer to perfomance I am referring to the feel of the breasts as well as to the lack of any reactions from these implants. Indeed I now know of a number of patients who have had these implants in for over 10 years and where the breasts continue to feel soft and supple.
I stopped using the PIP implants in early 2006 after noting a handful of ruptures in my patients. This in itself was not necessarily alarming, because as surgeons we know that ruptures can and will occur with all implants. Furthermore in the context of the numbers of implants I had fitted at the time, the handful of ruptures was not significantly different to other quoted rates at the time. The main reason I stopped was because of the attitude of the company towards me when I brought the rupture rate to their attention. It was one of almost contempt! In fact they suggested to me that I caused the ruptures myself by using some sort of sharp instrument at the time of insertion. Knowing full well that I never use a sharp instrument anywhere near an implant, I stopped all dealings with the company. I would also like to point out that our hospital, along with other surgeons and clinics at the time, submitted a notification to the MHRA about the rupture of the PIP implants as a matter of course.
Are the PIP implants dangerous?
In December 2011 a report from France was published which focused on a possible link between PIP implants and a rare type of cancer called anaplastic large cell lymphoma (ALCL). This arose after a French woman with PIP implants developed the cancer and sadly died. However, after reviewing the evidence, the expert group in the UK conducting the review agreed that there was no link with cancer. Despite this reassurance, a distinct anxiety remains within the general public.
There are effectively two issues with these implants. One, is the type of silicone that has been used to fill these implants(although it is not clear whether this applies to ALL PIP implants). It is not medical grade silicone and therefore has not been certified for its intended use. Having said that, this does not automatically imply that this silicone gel is toxic to the body. Thus far, toxicity tests carried out in France, the UK and Australia suggest there is currently no significant health risk to women who have had these implants. Furthermore it has also implicity been stated that provided the implants are intact then they pose no health risk to the individual.
The second is that there are suggestions that the implant shells are weaker and thus rupture earlier than other contemporary implants. Thus far this has not been substantiated although new data will be forthcoming.
Is there not an insurance that will cover this problem?
Although as doctors we are all covered by indemnity insurance to cover the likelihood of any medical negligence, this does not cover product liability insurance-which is what the PIP implant problem is about. Normally a manufacturers insurance would accept liablility if there was a product defect or fault. Unfortunately as a result of the fraud that the manufacturer engaged in, their insurance company has decided to not accept any liability claims. Therefore Mr Karidis will be covering all costs himself where applicable.
So how would I check the state of my implants?
The best way to check to the status of your implants is with the use of imaging, either through an Ultrasound scan or an MRI(Magnetic Resonance Imaging). Provided these are interpreted and reported by the appropriate experienced specialist then they can determine the status of your implants with great accuracy.
Why do I have to pay for a scan of my implants?
All implantable devices, whether this is a pacemaker, a heart valve or breast implants require some form of monitoring and attention at some point in their working lifetime to ensure they are functioning satisfactorily. It is always ultimately the responsibilty of a patient to ensure that the state of their health, as well as what is within their body is functioning well.
In the case of breast implants, this usually takes the form of a scan. In fact this is the only “service” or check that implants usually require. This is done to ensure that the implants are intact and not ruptured. Statistics tell us that the rupture rates of breast implants, regardless of the make of implants, starts to increase from the fifth year post op onwards. All of my patients who have had PIP breast implants are now at least 6 years postop with many 10-12 years post op. In light of this, it would therefore be sensible and prudent to start thinking about arranging scans intermittently from this point onwards to check the implants, regardless of whether there was a PIP issue or not. This is simply considered good practice.
Can the PIP implants be detrimental to me if the implants are intact? What is silicone “gel bleed” that I have heard about?
Provided the implants are intact on imaging, there is currently no evidence to suggest that the PIP implants are harmful. With an intact implant, all the internal silicone contents are held in position and remain encased within the shell or bag of the implant, and therefore are not able to interact with the bodies natural lining or capsule. Having said this, there occurs a phenomenon with all types of silicone breast implants called “gel bleed” . This is when very small quantities of the silicone, primarily silicone oil, diffuse or “sweat” through the implants shell or casing. This happens even though the actual shell or casing of the implant is intact.
All silicone implants exhibit silicone gel bleed to varying degrees, depending on the type of shell used. More modern cohesive gel type silicone implants (including the PIP made implants) have less “bleed” than older more liquid type of silicone implants. However it is important to understand that the quantities of silicone oil that “bleeds” is usually extremely small, certainly compared to the overall amount of silicone gel within the implant. There is also currently no evidence available that these small quantities of silicone “bleeds” cause any detrimental effects to ones health. In fact, The Food and Drug Administration in America has investigated whether there are any medical issues associated with exposure to silicones, including the process of silicone gel bleed, and determined there is no evidence of harm. Furthermore, in 1999, the Institute of Medicine in Washington, found the studies exploring human exposure to silicones, even at very high doses, to be reassuring.
What exactly is a rupture?
All patients who have had a breast augmentation will have been counselled and told that breast implants are not lifetime devices. Rupture of a breast implant occurs when a break, tear or breach of the outer envelope of the silicone implant occurs allowing the internal silicone gel contents to extrude. In many cases, due to the cohesive and solid, gel like state of the silicone, the contents remain within the capsule or scar tissue that forms around the implant. This is termed intracapsular rupture. In some cases however, the silicone contents breach the capsule and thus become “extracapsular”.
What causes a rupture?
Breast implant rupture can have many causes such as trauma from motor vehicle accidents, falls, or even extreme manual compression of the breast. Occasionally rupture has been reported with mammography when the breast is necessarily compressed for the purpose of screening . The majority of ruptures however have no obvious traumatic causes and are due to natural “wear and tear”. Many people forget that implants tend to move along with your body movements. In doing so, the outer shell or casing of the implant is therefore subject to natural friction and rubbing forces against the surrounding tissues. The more extreme, and the more regular these are, then the more “wear and tear” will occur on the implants.
What does “wear and tear” do?
Many studies have found degradation and degeneration in the silicone shell or casing of the implants when a rupture has occured. Material testing of aged silicone shells has also supported that degeneration of the silicone envelope occurs over time. In fact the breaking pressure required to burst silicone gel implants that have been removed from patients who have had the implants for a various numbers of years, decreased significantly as the time since implantation increased. Furthermore, mechanical testing of explanted shell specimens showed that the strenght of the shell declined significantly with age. It is therefore very clear that the risk of an implant rupture increases with the age of the implant.
So how often, and when, do implants rupture?
We know the risk of any implant rupture increases with time, and this has been confirmed through a number of studies. With respect to the expert group commissioned from the Department of Health, and on the currently available information, the statistical evidence on the rate of ruptures for PIP implants compared with other implants is incomplete and this risk therefore cannot be assessed accurately at present. For this reason it is unable to come to any view on comparative rupture rates.
From our practice however , and thus far, we have found that over a 6 year cumulative period the rupture rate is about 3 %, this is comparable to other implants. Of course I will be reviewing and assessing this figure as it evolves.
It is however very difficult to be entirely accurate with respect to exact rupture rates in general. According to several studies completed on a number of other implants, the current consensus and estimation is that the incidence of rupture increases gradually from the third year onwards. Taking in a summary of the results from some of these studies therefore, there is a reported 2% rupture rate at about five years, an 11-14%% rupture rate at eight years, a 10-19% rupture rate at ten years and a 49 % rupture rate at about 12-13 years.
What happens when a rupture occurs?
Silicone gel-filled implant ruptures are most often silent. This means that most of the time you will not know if the implant has a tear or hole in the shell. This is because 75% of ruptures occur intracapsularly-that is to say that the shell of implant and its contents remain with the capsule or scar tissue the body forms around the implant. This is the reason that patients with implants are usually advised to have scans, either ultrasound or MRI, a few years after implantation, to see the state and condition of their implants.
Of course, 25% of ruptures will be classified as being extracapsular-meaning the contents of the implant will have migrated outside the capsule. In these situations, associated symptoms may arise, such as hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening of the breast.
Contemporary implants however now mostly contain a cohesive gel in which the polymer ingredient is cross linked and the gel “form stable”. This cohesive characteristic of the gel reduces the risks associated with rupture as the gel is “held together” and is less likely to migrate into the breast tissues or the lymphatic system. It appears however that the gel within the PIP implant becomes significantly less cohesive over time compared to some other contemporary implants. The implications of this, in theory, include a greater tendency to interface with the local tissue and a greater potential to generate an inflammatory response. Nontheless, its important to remember that laboratory tests on samples from PIP implants, both in the UK and in France, have shown no significant evidence of mutagenicity (potential to cause cancerous mutations) or toxicity.
From my personal experience of dealing with ruptures of PIP implants thus far, I have not detected any clinically significant differences in inflammation in these patients compared to other types of implants.
So what do I do if a rupture is detected?
Of course when any scanning shows signs of a rupture or if there are signs or symptoms of rupture we recommend removal of the implant with all of its contents. This does not mean that it has to be done as an emergency and there is therefore no need to panic. In these situations surgery should be planned in the near future, ideally within the next few weeks. It is also advised that in the meantime extreme sports and body movements as well as manual handling of the breasts is minimised to avoid the possibility of the gel moving beyond the breast into neighboring tissue.
It is important to highlight also that the silicone gel in all implants, PIP included, does not “knit” or bind to the inner lining of the breasts in the vast majority of patients and therefore can be removed fairly easily. Furthermore, depending on the capsule thickness, it may sometimes also be necessary to remove the tissue capsule in addition to the implant. This will be determined at the time of surgery.
I have a gland that has come up in my arm pit. Why is that and is it dangerous?
If a lymph gland has become swollen in your armpit, as a new occurence, then it may mean that your implant has sustained a rupture and that some of the silicone gel has migrated towards your armpit. This is a natural route for the drainage systems of your breast. What has happened is that small fragments or particles of the silicone gel have moved to this area , getting outside the capsule(extracapsular rupture) and have been trapped by one or more of your lymph glands. As a result, the gland has swollen up.
This however, is a natural chain of events, because the lymph glands are essentially filters of the body. They have done their job by stopping the silicone from moving to other more distant parts of your body. It important to remember also that, it doesn’t take a lot of silicone to cause the glands to swell. In many instances it is only a few grams of silicone particles that have become lodged in the gland, thus making it swell. There are many other glands present in the area that will continue to filter the region and therefore serve and protect you from any other debris or matter.
Occasionally the glands can sometimes swell even without a rupture of the implants. This can occur due to something called “gel bleed”. This term is used to describe the escape of silicone oil from an intact implant in the absence of any gross holes or tears. This is not of any clinical relevance. However if we are in any doubt a scan will be able to confirm the integrity of the implants.
So do I have to have the glands removed now?
If you are having a ruptured implant removed,and also have an enlarged lymph gland, we do not usually remove the gland as well. The enlarged glands in most situations are relatively small and removing them does not usually confer any benefit. In fact surgery, to “dig out” a swollen gland could potentially disturb the lymph drainage in the armpit and cause problems with persistent swelling in the area. Therefore as a routine we do not disturb the glands. As mentioned above, the amount of silicone that is trapped in the glands is usually very small and so there is no clinical necessity to remove it. Very occasionally however, if a patient is particularly thin and the gland is particularly large, making it visible to the naked eye, then a decision may be taken to remove the isolated enlarged gland.
I need surgery again to exchange a ruptured implant, is the recovery going to be as bad as the first time?
Many patients are worried that another operation will be really onerous and painful in terms of recovery. In fact the reality is usually the opposite. This is because the pocket for the implants has already been made and so there is usually no need to make another pocket. Occasionally, adjusting the existing pocket is necessary , however from previous patients feedback, the comments are generally that “it was not nearly as bad as the first time”.
The procedure is usually done as a day case so patients can return back home within 4 hours of the surgery. Patients can return to office based work within 2-3 days whilst being sensible and avoiding extreme body movements for the first 4 weeks. Of course one must understand that there are always risks associated with any surgery and so therefore it is important that this is always borne in mind when contemplating this.
What should I do next?
It is not always straightforward. To begin, all patients who have had a breast implant operation, after a few years should get a scan to determine the state of their implants. All of my patients who have had PIP implants inserted are now nearly 6 years or more post op. Therefore all of my PIP patients for their own peace of mind, should have had a routine scan of their breasts. Once this has been done there will be two scenarios arising. The first one will be that an implant(s) will be found to be ruptured. In this scenario the outcome is unambiguous. A replacement operation should be sought.
The second scenario will be that the scans will be clear and show an intact implant. In that event the recommendation from the DoH is clear: that there is no specific safety concern identified which requires a recommendation of routine removal of PIP implants.
Having said that there will be some patients, particularly ones that have had the implants in for 8 or 9 years, who will think that as they are approaching 10 years post op, and knowing the increasing incidence of implant ruptures anyway as the years go by, will be prepared to have another operation to renew their implants.
Others however , particularly ones who are aversed to surgery and ones who want to put if off as long as possible, may be happy to continue a monitoring routine, at least until they feel they are in a position to have another operation to exchange their implants.
Every person affected will make a choice thats right for them. I will make myself available to all patients to assist with this decision making and offer and reassurance I can.
If you have any further questions or concerns please do contact a member for the Karidis team on enquiries@karidis.co.uk / 020 7432 8727
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