The French regulator of medical devices (AFSSAPS) has released an update on the PIP scandal.
The update states that new information discovered in their investigation of the affair has revealed that the PIP company appears to have been using silicone unfit for use in medical devices several years before 2001. Precisely when PIP began their deception remains unknown and no new implantation date has been quoted as a time before which patients need not be concerned.
This information means that many more women may be potentially affected by the defective implant scandal. Estimates in the U.K. are that an additional 7,000 women may have received defective implants. We are not aware of any estimate relating to the Irish market.
Women who previously thought that the problem did not affect them may now have to determine whether PIP implants were used in their surgeries over 10 years ago.
In many cases there will also be the added difficulty that the implanting clinic no longer exists, which means that patients may be unable to determine whether the implants are PIP at all, as is the case in Ireland with many former patients of Advanced Cosmetic Surgery Limited and Shandon Street Private Hospital.
The advice from the regulators of medical devices in Ireland and the U.K., the Irish Medicines Board (IMB) and Medicines and Healthcare products Regulatory Agency (MHRA) respectively, remains that patients who suspect they may have received PIP implants should contact their implanting surgeon or their G.P. for advice.
This stance does little to address the issue of women who received their implants from clinics that have since closed their doors such as Advanced Cosmetic Surgery Limited and Shandon Street Private Hospital. We are currently being contacted by many former patients of these clinics and in often there is no means of discovering what type of implants were used in their surgeries. Some of the surgeons who performed these surgeries were not resident in the state, flying in and out of the country to perform the lucrative operations, and are now not contactable by their former patients. In many cases there do not appear to be any existing records of the implants used. Also women regularly tell us that their local doctors report not being sufficiently well informed to give them useful guidance on the matter.
We are also hearing of many former patients who are having difficulty arranging the recommended ultrasound and MRI scans as some providing clinics stating that they will not deal with PIP concerns.
Aside from information on whether they did actually receive PIP implants or not, former patients of clinics which are still trading will be unlikely to be made offers of any kind. The limited offers made to former patients by these clinics do not extend beyond 10 years, and therefore any surgery that is required to remove or replace the problem implants will have to be paid for in full despite the fact that the patients have received a product that should never have been used in the first place