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By SheldonDavidsonSolicitors
Victims of the PIP breast implant scandal should now receive compensation.
Following a recent court ruling, thousands of women involved in the faulty PIP breast implant scandal can now seek damages. It is estimated that around 400,000 women around the world received implants manufactured by PIP (Poly Implant Prothese), which did not meet the required standards of quality and safety causing thousands of women to suffer from a wide range of serious health issues.
PIP used industrial grade silicone not approved for use in humans in their implants, and systematically deceived the regulators for a decade. The silicone PIP used is much less cohesive than the medical grade, so it spreads more easily in the body. It is often impossible for surgeons to remove all the gel that has leaked. PIP implants were found to be six times more likely to rupture than other bands, but the silicone gel can even spread into the tissues if the implant is still intact.
The PIP manufactured envelopes that hold the silicone in shape are often porous which allows the toxic silicone to leach. The leaked silicone forms lumps, often in the lymph nodes, lungs or other organs, which can lead to a condition called siliconoma causing pain and inflammation.
Women affected by the fraudulently manufactured breast implants have often suffered for many years with debilitating pain, extreme exhaustion, auto-immune disease, and cancer scares before the cause of the illness is identified.
Now, finally, these victims are able to pursue financial compensation for their suffering.
The PIP (Poly Implant Prosthesis) breast implant scandal emerged on March 29, 2010 when the French National Agency for the Safety of Medicines and Health Products (ANSM) banned the sale and use of pre-filled silicone gel implants manufactured by PIP.
The health security agency revealed that the company had been using industrial silicone gel since 2001 to fill their implant products. The silicone they had been using was not medical grade and had never been tested for implantation in the human body.
According to the application filed for CE marking PIP should have been filling its implants with NUSIL brand gel, which is certified for medical use and in particular for implantation in the human body.
For nearly 10 years, the company had been selling fraudulent Class III medical devices in more than 65 countries, which do not comply with health safety requirements.
Part of the scandal was caused by PIP fraudulently using cheap, low quality materials in their implant products.
But according to the French courts, the fact that PIP was able to do so, is down to the German safety certifier TUV Rheinland, who failed to recognise that the implants did not meet safety standards.
According to European regulatory legislation, a manufacturer of medical devices must use a notified body to certify that their products meet the standard of quality and safety for consumers.
PIP chose the German company, TUV Rheinland, the second largest quality assurance company in the world. This meant that TUV was responsible for evaluating PIPs design records and manufacturing process including, among other things, strict control of the raw materials used.
The fraud came to light many years later, in 2010, when Doctors noticed unusually high rupture rates in patients with PIP implants. This led to an inspection which eventually discovered large stocks of unapproved silicone materials at PIP’s manufacturing plant.
During a subsequent police investigation Jean-Claude Mas, PIP’s founder, admitted that his employees would remove evidence of the industrial silicone gel before TUV Rheinland made its annual inspections. It has now been shown that there were systematic failings in the audits carried out by TUV Rheinland and their subsidiary TUV France.
Had these companies carried out their duties to even the basic levels of thoroughness expected, it would have been obvious that PIP was not adhering to the approved design files using approved materials.
TUV Rheinland has been found liable for the damages caused, because the certification issued by the German group allowed PIP to label their products with the CE mark enabling them to be marketed worldwide.
The courts ruled that TUV must make an interim provisional payment of 3,000€ to each plaintiff for failing to carry out adequate audits to verify that approved materials were being used in the manufacturing process.
Although the final decision has not yet been made, PIPA said compensation ranging from 20,000€ to 70,000€ euros were being sought for each victim.
A first ruling on compensation is expected in September 2021.
Victims who have no particular complications can expect 6,000€ in respect of non-pecuniary damage and reimbursing the costs of removing and replacing the faulty implants.
Patients who have suffered major complications or incurred other losses should be compensated for several tens of thousands of euros.
Your compensation claim will take into account all the damages you have suffered, including moral, physical, aesthetic, psychological, and financial.
Those who have not claimed yet should contact the personal injury solicitors at SDS today for a free initial consultation.
Yes. Even if you haven’t had medical complications it is highly likely that you are entitled to compensation for the psychological impacts of living with the anxiety of knowing that a faulty implant was used.
“Almost all of us have lasting effects. I still have silicone in my organs.” Christine, Victim
PIPA, the association representing the victims, believes that epidemiological studies should be carried out on PIP patients because further consequences could be revealed. For example, there appears to be a higher incidence of autistic disorders in children who were breastfed by mothers with PIP implants.
The best way to find out if you have PIP implants is to check your medical notes. If you do, it is advisable to contact your GP or the clinic where the surgery took place.
To receive the amount of compensation you deserve, you need help from legal experts.
Sheldon Davidson Solicitors have extensive experience in all types of medical negligence cases. We can advise you on the best way to proceed, and will make sure your claim fully represents the severity of your suffering.
Our Medical Negligence Solicitors, act regularly for clients across Greater Manchester including Ashton, Bury, Bolton, Radcliffe, Prestwich, Middleton, Failsworth, Rochdale, Oldham and Whitefield.
We specialise in no win no fee injury claims, which means if you don't win, you won't have to pay.
Call us for free now using the number at the top of the page or complete the online contact form and a member of our team will get back to you.
