BBC Interview

Did you see Mr Banwell’s interview on BBC yesterday?  He was speaking about skin cancer and sun awareness.

For more information on our Family Mole Check service or medical grade skin care, please contact 0845 2600 261.  Mr Banwell is now consulting in Haywards Heath and London.

PIP breast implant boss arrested in France

The owner of a French breast implant maker at the centre of a safety scare has been arrested in southern France.

Poly Implant Prothese (PIP) founder Jean-Claude Mas, 72, was held at his home in Six-Fours-les-Plages, police sources told reporters.

In 2010, France banned PIP implants made with low-grade industrial silicone, amid fears they could rupture and leak.

Up to 400,000 women in 65 countries are believed to have been given implants.

Mr Mas remains at his home while police search it – as required by French law.

He is believed to have been detained as part of a judicial investigation started in December into manslaughter and involuntary injuries.

A second PIP executive, former chief financial officer Claude Couty, has also been arrested

Mr Mas has been under investigation since he revealed in a police interview last year that PIP ordered employees to hide the unauthorised silicone when inspectors visited its factory.

He told police that PIP had deceived European safety inspectors for 13 years.

But he has insisted they posed no threat to health and attacked the French authorities for offering to pay for their removal because it put women through a “surgery risk”.

What are the risks?

  • The silicone inside the implants is not medical grade – but was intended for use in mattresses
  • Tests have not shown any increased risk of toxicity from this filler compared with normal implants
  • But mechanical testing has shown the implant covers have an increased risk of rupturing
  • The gel inside can be an irritant, increasing the risk of inflammation – making removal more difficult
  • There is no increased breast cancer risk
  • One case of a rare form of cancer called anaplastic large cell lymphoma (ALCL) was recently reported in France
  • French and US experts suggest there is a small but increased risk of this cancer in women with breast implants in general

He also said he had “nothing” to say to women facing surgery for their removal and that victims had only filed complaints “to make money”.

Excerpts from Mr Mas’s interview have been re-examined by a French magistrate.

The BBC’s Christian Fraser in Paris said he had been “quite arrogant” about what had happened and had not felt any remorse.

In France, 30,000 women have been advised to remove the implants and 2,700 have filed complaints against Mr Mas.

Women in 65 countries – mainly in Latin America and elsewhere in Europe – have received implants made by the company, which closed down in March 2010.

Health officials in Germany, the Czech Republic and Venezuela have advised women to have them removed.

But the medical advice in the UK, where 40,000 are affected, is that there is no need for all the implants to be removed, only those causing problems such as pain or tenderness.

In England, the NHS will only replace them in exceptional circumstances, and the NHS in Wales said it would only do so when it was deemed medically necessary.

Women in Northern Ireland who received PIP implants for health reasons will have them replaced, but the NHS will only remove, not replace, those inserted for cosmetic reasons.

Scotland’s Health Secretary Nicola Sturgeon said concerned women who had them fitted privately would be offered advice and the option of removal if necessary. There are no records of PIP implants being used by the NHS.

The international police agency Interpol has said Mr Mas is wanted in Costa Rica over a drunk driving charge.

It said the “red notice” over an alleged incident in June 2010 was “totally unconnected” to PIP.

– BBC News, 26 January 2012

Plastic Surgery Regulations Reviewed

Health secretary Andrew Lansley has announced that an expert review into the regulations of cosmetic surgery will be lead by NHS medical director Sir Bruce Keogh. The review follows the recent concerns over defective French manufactured breast implants Poly Implant Prothese (PIP) which has left an estimated 40,000 UK women anxious over the effects of their faulty breast implants.

The government’s investigation will look into:

  • how the cosmetic sector can improve the quality and safety of care through better governance based on better quality data collection and improved professional development;
  • whether cosmetic products and interventions are appropriately regulated; and if not
  • how regulation of the sector in the UK and in Europe can be improved.

The Care Quality Commission will also be reviewing private providers of cosmetic surgery, to determine whether or not they “meet essential levels of safety and quality” and provide adequate levels of support to their patients. Mr Lansley said the Commission “has a wide range of enforcement powers that it can use to protect the safety of patients”.

In the UK general practitioners can legally perform breast augmentation and liposuction procedures without significant training. Similarly, beauticians can legally perform non-surgical treatments in their high street and mobile salons such as anti-wrinkle and filler injections.

Professor Sir Bruce Keogh, said: “The vast majority of practitioners in the cosmetic industry are professional and well skilled – but I’m concerned that the sector as a whole does not have the systems for monitoring the results for patients and alerting us to possible problems.  I will work with the industry to improve regulation and governance and increase consumer confidence.”

PIP Implants

With the recent media attention regarding the French manufactured breast implants, PIP, I would like to reassure all of my patients that I have never used PIP and only recommend high quality implants for my patients.
 
If you or anyone you know would like advice about safety or an update on developments with PIP implants please be in touch.  I will be holding the first of a series of educational evenings on Wednesday, 25 January and will be speaking about breast augmentation, implant replacement along with other surgical procedures.

Wishing you good health for 2012.

Paul Banwell

PIP breast implants: review to give findings

Some 40,000 British women with banned PIP breast implants are expected to learn later whether the government believes they should be removed.
France banned the implants, by the French firm Poly Implant Prothese, in 2010 and said they needed to be taken out due to a high risk of leaking.
They were found to have industrial, rather than medical grade silicone gel.
The UK government has so far said the risk is low but ordered a review because of conflicting data.
The findings of the review into the rupture risk will be released soon.
What rate?
The key question will be the rupture rate of the implants. The French authorities have quoted a rate of 5%. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said the rate was 1% – in line with other implants.
The health secretary, Andrew Lansley, ordered the review amid reports of rupture rates of 7% from one cosmetic surgery group, Transform. However, it says that rate was based on just seven out of 108 patients it fitted with PIP implants since 2005.
The organisation which represents the majority of UK private breast implant clinics has insisted the rupture rate is not abnormally high.
Sally Taber, director of the Independent Healthcare Advisory Services, said: “Following an audit of our members, which includes data on thousands of patients… we can confirm that the average rupture rates reported for PIP implants are within the industry standard of 1-2%.”
On Tuesday, Mr Lansley said the data from private companies had been “inconsistent” and was sometimes “inadequate” and of “poor quality”.
Prof Sir Bruce Keogh, the NHS medical director who is leading the review, said: “I am disappointed at the ability of some private providers to submit accurate and meaningful data. I am pursuing this with vigour.”
They were set a deadline of Thursday to provide the information or they would be named and shamed.
The advice from government officials has consistently been against removing the implants.
The chief medical officer for England, Prof Dame Sally Davies, initially said: “We currently have no evidence to make us think they should have the PIP breast implants removed.”
Then, three days before the review was due to report, Mr Lansley told the BBC: “The overwhelming evidence continues to support the advice we’ve given women previously.
“It is not advisable for women to routinely have implants removed because the risk associated with an operation of that kind would outweigh the benefit of removing these implants.”
The president of the British Association Aesthetic Plastic Surgeons, Fazel Fatah, has argued that all implants should be removed.
He said it would be impossible to find out the exact rupture rates and that the important issue was the quality of the silicone as “it is not fit to be implanted into humans”.
What are the risks?
• The silicone inside the implants is not medical grade – but was intended for use in mattresses
• Tests have not shown any increased risk of toxicity from this filler compared with normal implants
• But mechanical testing has shown the implant covers have an increased risk of rupturing
• The gel inside can be irritative, increasing the risk of inflammation reaction – making removal more difficult
• There is no increased breast cancer risk
• One case of a rare form of cancer called anaplastic large cell lymphoma (ALCL) was recently reported in France
• French and US experts suggest there is a small but increased risk of this cancer in women with breast implants in general

By James Gallagher Health reporter, BBC News