**PIP implants - INFORMATION**

PIP Breast Implants - Information

Firstly I would like to reassure all of my patients that I have never, ever used PIP breast implants. Therefore if I undertook your surgery then you do not need to be concerned about the adverse publicity surrounding these PIP implants.

Secondly, the recent adverse publicity refers ONLY to PIP implants. All other breast implants are safe.

The implants that I have used are all excellent implants with proven safety records. As I discussed with you at our pre-operative consultation, rupture is extremely rare and there are no long-term health risks associated with normal silicone implants.

 

PIP implants: the problem

Poly Implants Prostheses (PIP) implants were made by a French manufacturer. Initially these implants were manufactured to an acceptable level, but it appears that due to economic pressures, the company made a decision to make them to a lower standard. It appears that these changes were made some time in 2001. There appear to have been two significant changes in the manufacturing process:

1. The outer shell initially comprised a multilaminar silicone, but the outer protective layer was omitted, rendering the implants more likely to rupture.

2. At the same time, the gel filler was changed from medical grade silicone to cheaper, industrial grade silicone containing Baysilone (a fuel additive), Silopren and Rhodorsil (both used in the production of rubber tubing).

 

Thus, these implants rupture far more frequently than other silicone implants, and the leaking gel appears to be more irritant than the extremely inert medical-grade silicone.

As long as 5 years ago, reports started to appear in the Plastic Surgical Journals that these PIP implants had an increased risk of rupture and most plastic surgeons avoided them.

These implants were finally withdrawn from use on 31st March 2010.

 

What happens when an implant ruptures?

When a breast implant is inserted into the body, the body creates a thin wall of scar tissue all around the implant. This wall of scar tissue is known as a capsule and cannot usually be felt. Rupture of an implant usually causes the capsule to thicken and shrink down on the implant; known as a capsular contracture. This capsular contracture changes the shape of the implant and makes it feel harder. With time the breast may distort in shape and become painful. Pain is often limited to the breast itself, but the pain may be poorly localised and may even radiate to the chest wall and down the arm.

If the silicone leaks out of the implant and the surrounding capsule, the body usually identifies the free silicone rapidly and forms a wall of scar tissue around it so that it forms a lump of scar tissue and silicone; a silicone granuloma. This usually presents as lumpiness around the hardened implant. These lumps may or may not be tender.

Some silicone may be absorbed into the lymphatics around the implant capsule and these lymphatics carry the free silicone to the armpit, where the silicone collects in the glands (lymph nodes). These glands swell up and if the silicone is irritant, then this may cause pain, which may radiate down the arm.

The following case demonstrates a ruptured PIP implant in which silicone has migrated to the armpit glands (lymph nodes):

 

Figure 1. A PIP implant which has been removed from the right breast via the original scar. The implant that has been removed is shown contained within the ?capsule? of scar tissue, which the body has formed around the implant. Note, the right breast is smaller, but of a normal shape ? it is acceptable to leave the implant out and close the incision at this stage if the patient is happy to lose her implants. Alternatively, a new implant can safely be inserted into the pocket in the breast at this stage.

 

 Figure 2 . The capsule has been removed, revealing a large tear in the shell of the implant. Some of the silicone filling is missing.

 

Figure 3. The right armpit glands (lymph nodes) are enlarged with silicone. As they were painful, they have been removed via a separate incision in the armpit. Note that a new implant has been inserted into the right breast and the wound closed and dressed.

 

What should I do if I have PIP implants?

1. Firstly, do not panic. There is no urgent need to have these implants removed immediately ? they do not pose an immediate health concern.

2. Secondly, you should confirm whether you have PIP implants or not. Contact the surgeon or clinic who did your operation and they will provide you with this information.

3. Thirdly, if you do have PIP implants, and they are currently causing you problems (ie hardening, distortion of the breast, pain or evidence that they are leaking) then you should arrange to see a surgeon promptly to discuss removal of the implants.

4. Fourthly, if you have PIP implants but they are not causing any problems then there is mixed advice:

4.1. The current UK government position on PIP implants is that there is no need for removal of these PIP implants, unless they are causing problems.

4.2. The French government position on PIP implants is that, regardless of symptoms, these implants are substandard and should be removed.

4.3. My personal opinion is that these implants should be removed. The reasons for this are: they are substandard; they have a high risk of rupture (the consequences of which can be significant); and they contain non-medical grade silicone which, although is probably inert is not specifically manufactured for use in the human body and so should be removed.

 

How can these implants be removed?

Simple removal of PIP breast implants is a relatively safe, straightforward procedure. The old scar is opened and the implant and ?capsule? are removed together. It is a personal decision upon whether you wish to receive a new, safer implant, or would prefer to avoid implants altogether. This could also be considered an opportunity to change the size of your implants if you wish.

If you have painful silicone granulomas or lymph-node enlargement, then the operation may be a little more involved. I will discuss this with you in more detail if necessary at the time of your consultation.

Who should pay for implant removal?

There is much debate at the current time about who is responsible for paying for corrective surgery. The PIP company has gone into liquidation. Over 300 patients are being represented by a lawfirm and are attempting to recover costs. The clinics which inserted the implants are denying responsibility because they bought the implants in good faith from the manufacturer. I would recommend that in the first instance you appeal to the clinic where you received your implants in the hope that they will be prepared to undertake corrective surgery free of charge. If this fails, then you have 2 options:

If your implants are causing problems, then you are eligible for NHS surgery to remove the implants and thus alleviate your pain or discomfort. However, the NHS will not replace the implants for you ? so you will return to your pre-enlargement state.

If you do not have implant-related problems but are (understandably) keen to have the implants removed and exchanged for good quality implants then, at the current time, you will need to fund this operation for yourself in the private sector. I would urge you to visit an expert plastic surgeon to discuss this procedure. If you wish to arrange a consultation with me then you can contact Jude on 0121 361 8008. If you would prefer to find a suitably qualified surgeons in your own area then I would advise you to visit either SaferCosmeticSurgery (SCS) or the British Association of Aesthetic Plastic Surgeons (BAAPS) websites.

 

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