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Frequently Asked Questions About PIP Implants

May 24th, 2012

Mr Ahmad can categorically say that he has never used PIP implants but has a great deal of experience in dealing and advising patients regarding complications secondary to PIP implants. Mr Ahmad has always used either Allergan or sometimes Mentor implants. These are high quality implants using medical-grade silicone, and provide a lifetime warranty against rupture.

What does PIP implant stand for?

PIP implants stands for poly implant prostheses.

What is the problem with French PIP implants?

The implants are filled with non‐medical grade silicone and there have been reports the protective barriers are faulty. The PIP non‐medical grade gel is extremely cheap and costs a few pounds per litre. The PIP implants were made with a cheap, 75% non-­‐authorised gel, Mas allegedly told police. This non‐medical grade silicone was composed of raw silicone materials, the sort you might find in a mattress. They may have included chemicals like Baysilone, Silopren and Rhodorsil, which are reportedly found in fuel additives and rubber tubes.

If silicone leaks out it comes into contact with surrounding tissues where it has an irritant effect causing inflammation. The two silicones were so different that it is reported that the industrial silicone would behave like soapy water if ruptured, in contrast to the thick medical grade gel that doesn’t run.

The PIP implants are reported by the French device regulatory agency to have had a rupture rate of up to 10% in the first year of implantation. In addition, a separate phenomenon of leakage of the gel of intact implants (implant bleed) has been noted. This means that the silicone could pass out of the containing elastomer shell into the surrounding area even when the implant has not ruptured.

The occurrence of silicone bleed is thought to occur more readily due to the impurities in the gel. Non-­medical grade silicone contains lots of volatile low molecular weight silicones, which damages the shell causing more fragility and more bleeding. It also probably passes into the tissues once it has leaked more readily as it is of a low molecular weight.

In the French vigilance study as reported by the regulator this may occur in up to 11% of cases. The FDA declined to approve a saline PIP implant in 2000 based on a lack of safety data and subsequently issued a warning that they had found 11 deviations from good manufacturing practices during a visit to the PIP factory. 4000 UK women had these implants since 1994. The MHRA issued a device alert in relation to PIP implants in February 2011.

A lawyer representing women affected in the UK said some of his clients had complained of inflammation, fatigue and fibromyalgia, a musculoskeletal pain disorder. But the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said results from its own testing confirmed there was no evidence of genotoxicity (potential for cancer) or chemical toxicity of the filler material inside the implants.

Which implants are affected?

Affected products are PIP breast implants used since 2001. These implants were also marketed under the name M-­‐implant by the company Rofil Medical in the Netherlands and distributed in Germany by the company Rofil Medro. Affected Rofil implants are designated as IMGHC-­‐TX, MX-­‐IMGHC, and IMGHC-­‐LS. There is a strong suspicion that PIP and ROFIL implants that were manufactured before 2001 are also affected and are prone to a higher rupture rate and therefore silicone leakage.

How do I know what brand of implants I have?

It is recommended that you contact the hospital where you had your surgery or the surgeon who performed the procedure and ask them to check their records and tell you.

What happens when silicone leaks from an implant?

Cracks in the outer shell of the implant can allow silicone to leak out and enter the body. First, the silicone passes through the lymphatic system into the lymph nodes in the armpit. From there it is possible for it to move into the internal organs, but this is rare. This industrial grade silicone can cause severe inflammation, irritation, and in some cases effusion. On the basis of previous studies, no increased risk of cancer was shown.

What should I do if I have a PIP or Rofil implant?

Definitely go promptly to the surgeon/group who operated on you for a consultation. Some of these groups are offering removal of the implants and/or replacement at lower cost. Generally speaking it is believed that they are asking customers to sign disclaimers.

You can also go to your GP and have yourself referred to your nearby NHS hospital. Some of the trusts are offering a free removal of these implants but the replacement is not being offered on the National Health Service, at least in England. Of course, you can decide after consulting with your doctor not to have surgery and to return instead for regular check-ups.

If you decide not to have the implants removed, Mr Ahmad recommends a regular MRI scan, to check for rupture. But Mr Ahmad feels that these implants are unsafe and from a health point of view, he advises patients with these implants to seriously consider having them either removed or replaced at their earliest convenience.

Filed in PIP Implant News.


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