PIP BREAST IMPLANTS : UK Safety Inquiry
PIP BREAST IMPLANTS : UK Safety Inquiry
Why this petition matters
PIP Action campaign is a small, bold, social networking group of women who came together to fight for justice for victims of the global PIP breast implant scandal. By 2012, it was known that more than half a million women worldwide had been surgically implanted with PIP silicone implants which did not meet basic safety standards.
For more than a decade, PIP Action members have been campaigning for help, support, information, monitoring and access to healthcare. For more than a decade the truth about the real impact on health of silicone implants has been hidden from health professionals and patients.
In 2020, concerned about the impact of BI-ALCL (BIA-ALCL) or Breast Implant Cancer, PIP Action sent a Freedom of Information request to the MHRA, part of the Department of Health, to ask for details of adverse events reported in women with PIP implants. We were informed access to all PIP health data is strictly prohibited by FOIA 2000 section 44 (b) and disclosure is not permitted. It seems that the confidentiality clauses of outdated medical devices regulations in the EU are a more important obligation than patient health. Why would the MHRA want to keep details of PIP adverse effects reported by health professionals confidential?
These extraordinary confidentiality clauses are protecting the breast implant industry and negligent regulators who can continue to drag their feet in court and obstruct women’s access to timely medical treatment.
Political decisions in favour of industry and stakeholders have resulted in the gaslighting of victims of the PIP scandal. The MHRA insist there is no evidence for concerns about the safety of PIP Implants. But this is simply not true. Take the dubious experiment to compare SILICON found in a single sample of breast milk from a mum with ruptured PIP implants with a carton of semi skimmed cow’s milk. This is not evidence for the safety of breast feeding with PIP implants, it’s evidence of MHRA failings.
By 2021 the FDA’s Profile Registry collecting data indicated 63% of women with Breast Implant Cancer or BI-ALCL had a history of multiple device exposure. How many of those women have been exposed to PIP implants is not clear. The evidence to prove the dangers to women and babies of long term PIP exposures is being hidden.
We know some women and children exposed to PIP implants are suffering chronic health issues, serious injury and trauma as a result of PIP Implants, so why is this data being suppressed?
The breast implant industry enjoys quick, easy, large profits with zero accountability and no enforceable Duty of Care to patients. Victim blaming and medical gaslighting are just two of the tactics relied upon by industry to keep breast implants on the market. An understanding regulatory authority is essential. The Pharmaceutical and medical devices industries pay 85% of MHRA costs in fees.
In the UK more than 50,000 women are thought to have had PIP implants. Some women still have them. Women with PIP implants have died. How many women? The MHRA will not say. PIP exposed women, mums and babies are not monitored, checked or registered anywhere.
To date many thousands of women injured by PIP continue to suffer without support, healthcare or monitoring. This cycle of abuse is set to continue if our voices are not heard and the MHRA continues to operate in the interests of its fee paying clients. We want all UK MPs to understand how important it is to put patient safety first and implement precautionary measures to protect health and safety where there are clear concerns over the safety of surgically implanted medical devices.
We want women and babies exposed to unauthorised materials and manufacturing processes by unqualified people to be provided with the range of help and support vulnerable victims of crime should be able to expect. The devastating impact of PIP implants has been felt by almost every single woman affected.
PIP Action members are asking for a back to the beginning review of MHRA’s decision-making and where decisions and poor judgment have been relied upon by the agency, resulting in unnecessary pain and suffering, we want urgent changes to be implemented. We want PIP patients to be referred to England’s new Patient Safety Commissioner for fair and appropriate redress.
Sadly, PIP is not the only medical devices scandal affecting women overseen by the UK regulator MHRA in recent times. There have been many: the “metal on metal” prosthetic hip poisonings, surgical and vaginal mesh injuries, breast implant injuries and contraceptive devices injuries: all at great cost to the health and lives of the injured and at a cost to the NHS.
Please join us by signing our petition. Many of us affected are still in need of care, access to information, advice, implant removal surgery and ongoing monitoring.
Right now the MHRA are re-writing the UK’s rules for the safe regulation of surgically implanted medical devices. These include surgical mesh, breast implants, hip and knee prosthetics and pacemakers.
We simply cannot continue to rely on hopelessly outdated rodent experiments to infer human safety. Or wealthy private companies to conduct their own product testing or research. We simply cannot continue to allow regulators to turn a blind eye to harm to protect their income from industry fees.
Health & Safety are our basic rights. No other group of patients in need of medical attention is routinely turned away from healthcare because of their personal life choices. Many of us decided to get breast implants because we were reassured they were lifetime devices, safe and problem free. We were told silicone is inert and doesn’t cause health problems, we are routinely told robust evidence exists for the safety of breast implants. But where is it?
In 2016, French Health Authorities who were tracking PIP data, ran a check on all the safety data supplied by other breast implant manufacturers. By 2019 the brand leader Allergan Natrelle had been removed from the international market. Why? Allergan Natrelle are manufactured using polyurethane foam. Polyurethane foam is carcinogenic, it causes cancer. It’s one of several poisonous chemicals that are routinely found in the silicone breast implants.
Why do so many people, including implanting surgeons, believe silicone implants are safe? Well, that’s because industry spends hundreds of millions of pounds every year persuading plastic and cosmetic surgeons, health regulators and cancer charities that implants are safe. One of the tactics used by industry is the interchange between SILICON and SILICONE.
The two are totally different: silicon is an abundant naturally occurring substance, while SILICONE is a synthetic chemical cocktail. Watch out for times when journalists, surgeons, physicians, media and broadcasters interchange the two.
We know that the majority of people supporting this petition have been, or know of someone who has been negatively affected by PIP, another brand of silicone breast implants or a implantable medical device with a dubious record of safety and/or efficacy. If you have any concerns at all about your health, your implants or device, please seek medical help. Increasingly, GPs physicians and breast cancer clinics are aware of the problems women are facing, so please don’t be put off.
We are on a quest for truth, justice and redress. Please join us. Please write to your MP and ask them to attend our events in Parliament including the PIP Implant Debate 30 January 2023. If you have been exposed to PIP implants and need help, or you wish to lend a hand to the PIP Action Campaign, please sign our petition and get in touch, you will find us on Facebook, Insta and Twitter.
PIP Action Campaign