This is a bit of a side-line from our usual medical aesthetic non-surgical topics here at Cosmetic Courses UK.
However, we know that many of our delegates are GPs. With the current PIP Implants crisis affecting so many in the UK and many GPs having to give advice to worried patients, we thought that you might appreciate some clarification from our partner company, Aurora Clinics. As you may know, Cosmetic Courses is led by expert Plastic Surgeons so this team (including Cosmetic Courses director, renowned Plastic Surgeon Mr. Adrian Richards) are ideally placed to offer some guidance on dealing with PIP Implants patients. We hope you find this useful.
Backgound to the PIP Implants Situation:
- French brand PIP implants used between 2001 and the spring of 2010 are reported to be faulty
- In the spring of 2010, PIP’s Chief Engineer reported his concerns to the French authorities
- Between 30,000-40,000 women in the UK have these implants
- Between 2,000 and 3,000 of these implants were used by the NHS
- The majority of the remainder were used by the major Cosmetic Surgery Groups (including the Harley Medical Group, Transform and The Hospital Group)
- Aurora Clinics (Cosmetic Courses’ partner company) has never used these implants
- The PIP company has now gone into liquidation
What is wrong with PIP implants?
- In an effort to reduce production costs, the PIP implants company appear to have cut corners during the manufacturing process
- Investigations into the exact problems with each separate batch of PIP implants is ongoing
However, the recurring problems with PIP implants appear to involve:
- The implant shell
The shell of every silicone implant is made through a separate dipping and drying process. In PIPs, it appears that the numbers of dips was reduced; in particular the most expensive layer, which seals the shell from the internal silicone, may have been omitted entirely. This means that the implant is permeable to the internal silicone, resulting in “bleed” of the internal silicone through the shell.
In addition, the shell appears to be more fragile than other implant brands, with a higher rupture rate.
- The implant content
Medical grade silicone is expensive and has been tested internally on humans. Industrial grade silicone is less expensive and has not been tested on humans. It appears that, to reduce costs, a mixture of both types of silicone was used in PIP implants.
Ongoing toxicology studies are being performed on this silicone but we do not have any definitive data on this at present.
Findings
One of the reasons why definitive data is lacking on PIP issues is that there is no national registry of these implants. A registry did exist but the government withdrew funding for this in the mid 2000’s.
Because of this, we do not know exactly how many PIP implants were used in the UK or which women have them. The Government is now calling for the breast implant registry to be re-established.
Aurora Clinics Surgeons are working with major professional bodies, BAAPS and BAPRAS, to record data on the PIP implants we remove.
Our findings to date indicate that, of the PIP implants that we have removed:
- 30% are severely ruptured
- 60% have significant silicone gel-bleed on their surfaces
- 10% are in a similar condition to other implant brands when removed
Further analysis of the performance of particular batches of PIP implants is ongoing. Many of the implants that have ruptured have only been inserted within the last 4 years.
Recommendations:
Because of these findings, we feel that all women with PIP implants should consider having them removed.
If women with PIP implants do not have information on their implant manufacturer they should request this from the surgeon or company who inserted them. This should be provided promptly and efficiently.
The requested information should include the:
- Size in cc’s
- Type (high, ultrahigh (UH) etc.)
- The batch and lot number. The batch number is a 5 digit number and the lot number a 3 digit number
Symptoms
Many of the patients we have seen with PIP implants report generalized symptoms of fatigue, hair loss and joint pains. These are difficult to attribute to PIP implants and there is no guarantee whether their symptoms will resolve if the implants are removed or exchanged.
Approximately 50% of our patients report symptoms in their breasts, necks, axilla or arms. These range from generalized aches and tenderness to parathesesia. Again, these are difficult to attribute solely to the PIP implants.
Examination
In most cases, it is not possible to determine whether the PIP implants are intact by examination alone. A significant number of our patients have silent ruptures.
Indications that the implants may be ruptured include:
- Distortion in the shape of the breast
- Softness of the breast with a lack of palpability of the rim of the implants (particularly in slim patients)
- Axillary or neck lymphadenopathy
Management
The majority of the women that we see are – understandably – extremely anxious about their PIP implants. In most cases, they are very well informed about the issues with these implants from support groups and forums on the Internet.
Some hospital groups, including BMI, have offered to pay for the removal and replacement of any PIP implants they have inserted.
Some of the other major Cosmetic Surgery companies have offered to remove and replace PIP implants which they have inserted. This is only the case, however, if they have been shown to be ruptured by Ultrasound or MRI scans.
Management recommendations
At present, both the government and the private medical groups are recommending that women with PIP implants seek advice from their GP’s.
From our experience, we would recommend:
- If the PIP implants have been inserted by the NHS, refer patients to your local breast unit
- If there is definite evidence of implant rupture, refer to the NHS, the surgeon or private group which inserted them. The treatment for these patients should be free of charge.
- If there is no evidence of rupture clinically, implant removal without replacement is permitted in some cases under the care of the NHS
- If your patient would like further investigation, most NHS units will offer to assess the integrity of the PIP implant
In most cases, radiological investigations will demonstrate implant rupture but not gel bleed.
If there is no clinical or radiological evidence of implant rupture the patient can:
- Choose to have the PIP implant retained and undergo regular clinical and radiological surveillance until more definite data on the performance of each batch of the implants and the toxicology of the silicone gel is known
- Choose to have the implants removed or replaced
Unfortunately, at present, neither the NHS nor some of the private providers are offering free PIP replacement unless there is definite evidence of implant rupture.
Many women are reluctant to wait for this data and are choosing to either have their PIP implants removed or replaced with high quality Allergan or Nagor implants.
Aurora Clinics are offering a cost price package deal for PIP implants patients, in partnership with BMI. If you are interested in referring your PIP implants patients to Aurora or would like more information on what this cost price deal entails, please contact [email protected] or 0800 328 5743 . You can also watch videos about our removal and replacement surgery plus support packages via this link.
