The PIP Breast Implant scandal has featured heavily in the health news over the past years. Circa 40,000 women were affected in the UK and it was France’s National Agency for Medicines and Health Products (the ANSM) that initially began to be suspicious of these implants in 2009 due to a number of surgeons reporting a high failure rate. There has now been an Allergen textured breast implants recall.
The PIP Scandal
PIP used unapproved, in-house manufactured industrial grade silicone, instead of medical grade silicone. Allegedly PIP used their own silicone due to a silicone shortage in 1993, creating a mix of 75% non-authorised silicone, (at 1/6th the price of medical silicone), with 25% of approved silicone. PIP worked under the assumption that had their in-house silicone been submitted for Authority approval, it would have been approved, so why worry?
Their business was ultimately shut down in 2010 for using chemicals normally used as fuel additives or in the manufacture of industrial rubber tubing and their founder was sentenced to 4 years in prison for aggravated fraud.
In the UK, we saw the NHS offer consultations and where necessary, removal procedures but they would not replace implants. Women that had paid for breast implant surgery privately however, faced a tougher battle. With contradicting advice as to if the implants should be removed, it took some convincing for private clinics to offer revision surgery and initially, to even offer free consultations.
There still is not sufficient evidence to show the silicone used actually causes any harm as long as the implants do not rupture.
It was not until 2017 that any of these women were to be awarded compensation, £3,000 each, which barely covered the cost of their original surgery. In May 2019, many women were served court papers demanding they repay the money they received as they did not serve sufficient evidence to prove they received PIP implants.
Breast implants are big business, the cosmetic surgery industry in the UK alone is worth £3.6billion. It is vital that Regulators and Authorities pay close attention to this industry, ensuring profit margins do not come before patient safety. PIP is a shining example of where it can go wrong.
Allergen Textured Breast Implants Recall Worldwide
Two weeks ago, a breast implant scandal that has been brewing since 2017 finally came to a head. Allergen, makers of BioCell™ textured breast implants, have recalled these implants worldwide owing to the risk for breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL).
Since PIP in 2011, France have maintained a register of all breast implant surgeries and in the same year, the FDA in the United States, began tracking incidents of BIA-ALCL. The FDA analysis demonstrated that the risk of BIA-ALCL with Allergan BIOCELL textured implants was approximately six times the risk of BIA-ALCL with textured implants from other manufacturers, and requested they be withdrawn from the market in July, and France banned all textured implants in April 2019.
In the UK in Dec 2018 the MHRA said “We are aware Allergan have stopped selling textured breast implants and tissue expanders and intend to withdraw remaining supply in European markets…There is currently no evidence of an increased risk to patients and there is no need for people who have Allergan breast implants to get them removed or have any additional clinical follow-up.”
Following the FDA recommendation, the global recall, and the ANSM findings, the MHRA said “Our advice has not changed and there is no need for people with these breast implants to have them removed.”
Where does this advice leave women?
Registry data in other countries reports significant increases in the risk of developing a form of cancer from these implants. No monitoring from the NHS, no private consultations for advice or replacement unless patients can pay for it, and years of anxiety ahead.
There is a notable difference here of a reactive vs a proactive response between regulators but for those women who still have their original PIP implants in situ, unable to afford to replace them, they will have a great amount of sympathy for their sisters with Allergen implants.
Tamlin Bolton, Solicitor at Pryers said “Let’s avoid the PIP battle and deal with things upfront. Once bitten twice shy. Responsibility must be taken for those women who have died as a result of BIA-ALCL, women living in a state of fear of developing the disease and women living in the present with the disease, and I would call on Allergen, as manufacturer and producer of these implants to act quickly to offer these women a resolution.”