PIP SCANDAL – What is it?

All cosmetic and plastic surgery carries some risk and patients should be informed of the latest scientific evidence and knowledge, before they consent. However these risks are increased when dubious products and/or practitioners are involved, and the avoidable risks can become life threatening.


Sadly the world of cosmetic and plastic surgery is rife with postoperative complications and botched treatment outcomes. There are multiple factors involved here: patients looking for cheap deals either in their home country or abroad, unethical practices, unqualified practitioners and in some cases the responsibility lies with the manufacturers of medical devices.


Prior to 2010 many breast augmentation patients had PIP implants without knowing they carried higher risks of rupture and migration of the silicone.


Unfortunately, there are many stories on the internet which can cause patients to worry and have anxiety and other psychological issues. Here at Ministry of Aesthetics we like to educate our patients and the public so they can be well informed and guided to make the best decisions.

The PIP scandal

Let’s shine some light on the infamous PIP scandal which broke out in 2010 and has been time stamped as one of the most prominent cases of medical negligence in recent times. According to research conducted, almost 400,000 women were impacted globally, with 47,000 of these being from the UK, and these implants in question (made by French firm Poly Implant Prothèse PIP) were not designed for medical use as the materials used were found to be industrial grade silicone and the shells ruptured more easily.

A German Cosmetic surgery certification was also found liable after it had awarded safety certificates for these implants.

PIP, at the time, when the scandal broke out was the third biggest supplier of breast implants in the world and was found guilty of using sub-standard silicon in the implants that were not cleared for human use. They sold implants globally for over two decades until investigators discovered the fraudulent business in 2010.

What was the impact of this?

Most women reported a range of mental and physical issues that included inflammation, extreme pain, headaches, anxiety, infections and low energy. Many of these women suffered silently for years before actually realising that these health issues were due to their possible faulty implants. Some cosmetic surgery clinics were able to notify their patients about the dangers once the PIP scandal broke out but most did not receive any communication at all from their surgeons or clinics that were involved in these implant procedures because of many reasons e.g. no registration of implants that were implanted.

Some women had to take matters into their own hands as these implants were leaky and their bodies were exposed to this silicone, meaning they had to pay out of their pockets to have these removed. However a large proportion of women weren’t able to afford a second procedure leaving them in dire straits years later.

Who is entitled to compensation?

The French court’s ruling was that all victims who have suffered as a result of unknowingly receiving the faulty implants must receive compensation.

Whilst many women have this awareness,  there are still some others who have no clue about the implants they have had and if they can make a claim.  In some cases there are those who went abroad for these surgeries and have no chance of being compensated. Sometimes there is also a factor of their treating clinic having gone out of business.

What is the support available?

In the past few years many independent support groups have formed to help these victims come to terms with what has happened and by raising awareness how they can address various emotional and physical health issues.

Some of the most prominent include, Official PIP Implant Campaign (OPIC) and PIP Action Group (we have not had any contact or experience with these organisations but as patient it is good to explore the information)

There are also private clinics here in the UK that have stepped forward and offered to remove these breast implants free of charge.

Additionally, you can also learn more about making a breast implant compensation claim here.

Update

In a recent update, the FDA has updated the Risks and Complications of Breast Implants, clarifying information about implant removal and adding ultrasound as an acceptable alternative imaging for screening for rupture in the case of asymptomatic patients, to Silicone Gel-filled Implant Rupture.

Some Risks of Breast Implants

  • Implant complications such as changes in breast and nipple sensations and breast pain.
  • breast implant associated ALCL or SCC
  • Capsular Contracture where a scar tissue forms around the implant and squeezes the implant.
  • Rupture and rippling
  • breast implant illness, connective tissue disease, reproductive problems
  • Impact on breastfeeding

What steps have  been implemented thus far?

-CE markings /certifications to become the norm on any implant or medical device. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

– BAPRAS (British Association of Plastic Reconstructive and Aesthetic Surgeons) has been pushing for stricter regulations and standards and also to have markings on any implants or devices used so that they can be registered in a central system and be tracked with the National Breast Implant Registry via their app. 

-Patients to be more aware of this- Each implant has a unique serial number printed directly on it or on the box in which the implant arrives as well as on the tracking label.

And Ultimately the key thing is to ensure that the clinic and surgeon you have chosen has a solid reputation. Check reviews and CQC rating if available. Look at the surgeon’s credentials and registrations and associations, like where has he/she qualified from, how many years being in the profession etc and do your due diligence with the clinic team as well, as this is equally important for post surgical aftercare.

Here at The Ministry of Aesthetics our surgeon Dr Brian Simons is highly qualified and experienced in this area, specialising in Breast Reconstruction and Augmentation. Our aftercare is world class and we have many testimonials from patients that have had positive results.

Contact us and book a consultation to discuss further.

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