subscribe: Posts | Comments

PIP Implants Declared Safe

0 comments
PIP Implants Declared Safe

New test shows that PIP breast implants are not toxic…

Earlier this year concerns arose over the safety of Poly Implant Prostheses (PIP) hydrogel breast implants after it emerged that the implants had been sold without a protective barrier and containing an unapproved gel.

However, new tests conducted by UK researchers have shown that there is no evidence to prove that the implants are toxic.

pip implants decleared safe PIP Implants Declared Safe

PIP Implants Are Safe

French experts began the inquiry after noticing a rise in patients with ruptured implants. They found that the implants lacked the original protective barrier, and also contained a material different from the one first approved.

In March the Medicines and Healthcare products Regulatory Agency (MHRA) announced that no more PIPs should be implanted, and any remaining ones should be returned to the manufacturer.

Poly Implant Prostheses –also the name of the company that manufactured PIP hydrogel implants – did try to contact the gel manufacturers for studies on the unapproved gel, however there were none, because the gel had originally been designed for mattresses.

The news worried many as an estimated 50,000 women in Britain alone have the implants; thankfully the MHRA has now received encouraging results that show the implants are neither toxic, nor cancerous.

Dr Susanne Ludgate, director of clinical devices for the agency, said:

Its reassuring that our test results have shown no evidence of any associated risks with the filler material…

We are however waiting for the results of the French tests which are more extensive and include mechanical testing of the implant shell because there may be a suggestion of an increased rupture rate compared with other breast implants..

We will update clinicians and women once these test results are available and provide further advice on patient management as necessary.

BAAPS praised MHRA’s results. Nigel Mercer, president of BAAPS, said:

Hopefully this will reduce the anxiety of patients whilst further studies are expected from France…

Our advice remains that women with suspected rupture contact their surgeon and undergo an ultrasound and removal, as they should with any ruptured implant.

He also added that surgeons who implanted PIPs should not be held responsible as they have ‘no way of knowing.’ The PIP company has now gone into administration, and all devices were recalled earlier this year.


Comments are closed.