The Harley Street Journal

Bi-monthly newspaper for the cosmetic and plastic surgery sector

breast implants

Implant Rupture Rates Rise

by

10180253_xxlCases of breast implants rupturing in Britain have risen more than five times in just three years, it has been revealed this morning.

Over 1,500 cases of burst implants were reported in 2012/2013, compared to just 293 in 2009/2010, according to new figures.

Mr Douglas McGeorge, a plastic surgeon and former BAAPS president, told The Sun many women are still insisting on over-sized breast implants and suggested problems in recent years where some cheaper implants were not up to standard and were ‘prone to failure’.

Problems reported in the past few years come following the French firm Poly Implant Prothese (PIP) being exposed globally for manufacturing implants using industrial grade silicone.

Almost 50,000 women in the UK alone were affected by the well-documented scandal, which came to the attention of the world after surgeons and doctors found worryingly high numbers of breast implants were rupturing.

In 2012 and 2013, the Medicines and Healthcare Products Regulatory Agency received 2,427 reports of problems with augmented breasts, with 1,543 of these relating to implant ruptures.

Faulty breast implant firm founder to serve four years

by

iStock_000010195246_LargeA French court has sentenced Jean-Claude Mas, the founder of Poly Implant Prothèse (PIP), to four years in prison on aggravated fraud charges for selling breast implants filled with industrial-grade silicone that were prone to rupture to some 300,000 women in 65 countries.

Mas, 74, was also ordered to pay €75,000 in fines.

PIP’s former general manager Claude Couty was sentenced to three years in prison, two of them suspended, and ordered to pay €30,000 in fines.

Quality control director Hannelore Font and production director Loic Gossart were each sentenced to two years with one year suspended while research director Thierry Brinon was given an 18-month suspended sentence.

Prosecutors had called for the defendants to receive sentences ranging from six months to four years in prison. They also urged the Marseille court to impose a €100,000 ($137,000) fine on Mas, who they dubbed “the sorcerer’s apprentice of implants”, and to ban him from working in medical services or from heading a company.

More than 7,000 women have declared themselves civil plaintiffs in the case and hundreds packed the court during the April trial, which was moved to the Marseille convention centre.

Health risks disputed

The scandal first emerged in 2010 after doctors noticed that PIP’s implants had unusually high rupture rates. During a month-long trial, the defendants admitted using industrial-grade silicone but Mas denied the company’s implants posed any health risks.

More than 7,500 women have reported ruptures in the implants and 15,000 have had them replaced in France alone.

Health officials in France and other countries including the Britain have said the implants are not toxic and do not increase the risk of breast cancer but have nevertheless urged their removal.

The court will not rule on the question of whether the implants pose a risk, only whether the five managers defrauded their clients as well as German safety standards firm TUV, which approved the implants for the mass market and was last month found liable in a case tried in the French city of Toulon. The court ruled that the firm had “neglected its duties” by failing to properly vet the implants.

TUV was ordered to pay more than €50 million in compensation to six distributors and to more than 1,600 women fitted with the implants.

Mas, a one-time travelling salesman who got his start in the medical business by selling pharmaceuticals, founded PIP in 1991 to take advantage of the booming market for cosmetic implants.

He built the company into the third-largest global supplier of implants but came under scrutiny when plastic surgeons began reporting an unusual number of ruptures in his products.

Health authorities later discovered he was saving millions of Euros by using industrial-grade silicone gel in 75 percent of the implants. PIP implants were banned and the company was eventually liquidated.

PIP had exported more than 80 percent of its implants, with about half going to Latin America, about a third to other countries in Western Europe, about 10 percent to Eastern Europe and the rest to the Middle East and Asia.

The British Association of Aesthetic Plastic Surgeons warned in December that, although criminal behaviour cannot be prevented by regulation, the system ‘endangered’ the safety of women worldwide by failing to discover Mas’ illegal activities over ten years.

Consultant plastic surgeon and BAAPS President Rajiv Grover said:

“There can be no way of compensating the victims of PIP for the scale of this betrayal, and in that respect no sentencing can ever be adequate punishment. It’s appalling that it has been years since the PIP crisis first made headlines in the UK and despite the Government urging the private sector to replace the defective devices, thousands of women are still left with no support from their original providers.

“Whilst there is no way for regulation to prevent criminal behaviour, undoubtedly the system failed hundreds of thousands of women worldwide who, for all anyone knew, could have been walking around with implants filled with toothpaste. That such a dangerous situation was allowed to develop unchecked over the last ten years is totally unacceptable and we welcome the implementation of pragmatic changes that will protect patients in the future.”

PIP implant breast cancer link ruled out

by

10135001_xxlFaulty breast implants widely known as PIP (Poly Implant Prosthese) were back in the news recently, with the release of a new report that found that women who have the faulty implants are not at higher risk of cancer.

Breast implants are liable to split (rupture). Concerns had been raised that PIP implants, which contain industrial silicone rather than medical-grade fillers, would expose women to potentially toxic elements if they ruptured. It was believed that this could then lead to cancer.

However, a new European Commision scientific report suggests that ruptured PIP implants do not cancer. The report also found that there is no convincing evidence to justify routinely removing intact PIP implants. However, it says concerns about the high rupture rates associated with PIP implants means women who have these implants should be regularly examined by a doctor.

About 47,000 British women in the UK are thought to have the implants. PIP is a type of silicone implant made by a French company. Investigations by French authorities found they contained industrial silicone rather than medical grade fillers unauthorised for use in breast implants, rather than medical grade fillers. Marketing, distribution and use of the implants was suspended in March 2010.

Tests also indicated that PIP implants had a higher probability of rupturing or leaking silicone than other implants.Concerns were raised after a womea known to have PIP implants died of a rare form of cancer called anaplastic large cell lymphoma (ALCL). After reviewing the available evidence, an expert committee stated that this was just a tragic coincidence and was not directly caused by the implants.

In the UK, an expert committee concluded that there was not enough evidence to recommend the early removal of PIP implants.

How did experts conclude there was no link between cancer and PIP implants?

The new report has been produced by the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). It is an update of a previous report by SCENIHR in February 2012 on the same subject, taking in new evidence.

The report is called a “Preliminary Opinion” and presents the views of independent scientists rather than the European Commission. The report is now out for consultation, which will run until December 13 2013, with interested parties invited to provide comments online.

 

What evidence did the report look at?

The SCENIHR experts looked at a number of different sources of evidence, including:

  • A review of the scientific literature on breast implants, particularly focused on papers published since 2012 when the previous opinion was published. 2,597 articles were found on silicone breast implants generally and 948 on PIP implants.
  • Detailed assessments of the health implications of PIP implants produced by individual member states and other countries, in particular by the UK, France, Australia, Spain and Sweden. Much of this work is not yet published but the committee felt it important to examine.
  • Information about rupture and leakage of PIP implants, gathered by the International Conference for Plastic Reconstructive and Aesthetic Surgery (IPRAS).
  • Responses from plastic surgeons to a questionnaire devised by the committee and sent out in 2012, primarily to identify any differences in adverse effects between patients with PIP implants and those with other breast implants.

 

What did the SCENIHR find?

The SCENIHR found that PIP silicone gel-filled breast implants are reported to have a higher rate of rupture than other silicone breast implants, and ruptures tend to occur earlier in the implant life than is the case with other implants. These reports indicate that the shell/patch of a number of batches of PIP implants is of inferior quality, which may reflect variations in the manufacturing process.

The risk of PIP implants rupturing increases with time, the SCENIHR found. Quantifying the actual increase in failure rate is problematic, says the report, because the failure rates of non-PIP implants are not well documented. Estimates of rupture rates after 10 years for PIP implants are 25-30% compared to 2-15% with other types.

Since the previous SCENIHR opinion on PIP breast implants, several chemicals called cyclic siloxanes (known as D4, D5 and D6) have been identified in PIP devices at higher concentrations than in other silicone breast implants. This has led to investigations of their possible toxicological consequences, if a PIP ruptures or leaks.

These chemicals are commonly present in the bodies of women even without breast implants, as a consequence of the widespread use of siloxanes in many domestic products. Cyclic siloxanes D4, D5 and D6 are non-toxic and not irritant in standard tests.

In some cases, implant gel-bleed or rupture has been associated with an inflammatory reaction either locally or in regional lymph nodes. In other cases, ruptures were free of symptoms.

Neither implant rupture, nor local inflammation, has been found to be associated with breast cancer or ALCL (anaplastic large cell lymphoma), the SCENIHR says.

While there are differences in rupture rates, there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer. However, ruptured implants should be removed, says the SCENIHR.

The SCENIHR still recommends that women with PIP breast implants should have regular clinical examinations, and where deemed appropriate, individual counselling and breast imaging with ultrasound or MRI. However, it says that there is currently no convincing medical, toxicological or other data to justify routine removal of intact PIP implants as a precautionary approach. Implant removal may be considered for women who are anxious about their PIP breast implant, the SCENIHR says.

 

Conclusion

The European Commission report should be reassuring for women with PIP implants – after painstaking and detailed research it would seem that the risk to long-term health of PIP implants are minimal.

The scandal over the manufacturing of the faulty implants highlights the importance of choosing a reputable cosmetic surgeon, as it is believed that many women in the UK received PIP implants from “cut-price” surgeons overseas.

Surgeons reiterate call for further testing of defective implants

by

7251789_xxlIn response to an opinion article published in the Journal of the Royal Society of Medicine calling for a more thorough investigation of the health impact of PIP implants, the British Association of Aesthetic Plastic Surgeons has reiterated its own previous statement that there continue to remain ‘unanswered questions’ about the controversial devices.

According to consultant plastic surgeon and BAAPS President Rajiv Grover:

“Whilst the article in question is entirely an opinion piece and not presenting any new data, at the BAAPS we do agree – as we have said before – that there remain unanswered questions regarding the possible effects of these chemical compounds. We reiterate our call for analysis to be conducted on collected samples taken ‘in vivo’ rather than off-the-shelf, as it would also be advantageous to examine what impact body temperature and conditions have on them. It was only change occurring in implants inside the body, which triggered a recall of soya bean (Trilucent) implants years ago.

“Women who had or still have PIPs and the surgeons removing them know that more research is needed to explain what they are seeing and experiencing. At the BAAPS we have remained constant in our view – these defective devices have no place within the human body. The whole sector, and in particular the patients affected, deserve thorough answers.

New breast implants come equipped with radio frequency chip to help diagnose problems

by

iStock_000009518082LargeEstablishment Labs is set to market a new silicone breast implant equipped with a radio frequency identification (RFID) microchip that gives doctors and patients easier access to information about the implants, including their serial number, manufacturer name and other data.

 Using a handheld device, doctors would be able to quickly determine the make and model of the implants even years down the road. The innovation could provide an extra level of safety assurance following health scares like the one generated by a French company last year after it was discovered their products had been made with an unauthorised silicone filler. The implants manufactured by Poly Implant Prothese (PIP) had double the rupture rate of similar products, causing health risks such as scarring and breast malformation to about 300,000 women in Europe and South America.
The new product, Motiva Implant Matrix Ergonomix, will soon hit the market in 28 European countries, and the company is seeking approvals in South America, the Middle East and Asia, Establishment Labs said.

The microchip technology “is about giving women the power of verification and control throughout the life of the device, if they choose to have breast implants,” the company’s CEO, Juan Jose Chacon-Quiros, said in a statement.

“We are already in final talks with the biggest groups of clinics in Europe to provide the highest degree of safety, which patients have been rightly demanding after the recent breast implant scare in the EU.”