Are breast implants safe?|
What caused the current breast implants safety concern?
Between 2001 and 2010 about 80,000 Poly Implant Prothèse (PIP) implants representing some 40,000 women) were sold in the UK.
It is believed that the implants were available to purchase for a mere £100 (up to £700 less than the medical-grade version), their low cost helped grow their popularity and helped PIP corner the market in cut-price prostheses.
From about 2006 onwards, concerns began to emerge among cosmetic surgeons in the UK about the performance of PIP implants. The alarm was originally raised after many patients and surgeons reported premature rupturing.
Implants are designed to last a minimum of ten years however the lifespan of PIP implants was averaging at as little as just three years.
After numerous complaints and concerns received, In March 2010 the French medical regulatory authority Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) began an investigation into the company.
What happened next?
On the 29th March 2010, the French medical device regulatory authority (AFSSAPS) informed the MHRA in the UK that it had suspended the marketing, distribution, export and the use of silicone gel filled breast implants manufactured by Poly Implant Prothèse (PIP), They also recalled all of these devices in France.
Poly Implant Prothèse had been using industrial grade silicone to fill breast implants instead of the medical grade specified for the CE mark.
The low-grade industrial silicone was the type used to fill mattresses — and was never approved by health authorities. AFSSAPS revoked the CE mark.
MHRA promptly issued a medical device alert to all UK clinicians and cosmetic surgery providers, asking them to cease using the implants.
The Poly Implant Prothèse (PIP) factory was shutdown and their products banned after it was found they had used the chemicals Baysilone, Silopren and Rhodorsil in their implants.
These chemicals are normally used as a fuel additive or in the manufacture of industrial rubber tubing.
As a result of this thousands of women in the UK are still battling through a very complex health situation which has rocked the core of cosmetic surgery, and thousands more pondering the prospect of breast surgery are asking the one unanswered question; ‘Will my breast implants be safe?’
In all the furore about the banned PIP breast implants, women are now concerned about breast implants in general.
Kelly Parker-Browne, a 34 year old mother of two and legal admin clerk says: “I have been considering breast augmentation since having two children, but the whole PIP scandal has left me thinking what if this happens to me?"
However, Plastic Surgeon JJ Staiano says: "breast augmentation remains one of the most popular cosmetic operations that we perform because it gives instant and life-changing results, despite all of the negative press recently associated with PIP implants."
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