1. Reliability of Breast Implants UK National Health Service Experience POLY IMPLANT PROTHESE (PIP) BREAST IMPLANTS: FINAL REPORT OF THE EXPERT GROUP Before After

2. Background UK NHS did breast implants, some elective and some reconstructive starting in 2001 In mid-2000s, leakage was cause for some explants. Patients sued to get UK NHS to pay for explants – PIP (France) was implicated. PIP claimed quality control problem, swapped industrial for medical grade silicone UK “Expert Group” investigated, concurred, and paid – http://www.nhs.uk/conditions/breast- implants/documents/pip%20expert%20group%20final%20 report.pdf I asked for data, and they sent annual counts

3. Implants Mfg.-> M1M2M3PIPTotal 20017023526625402256 200214656726346193390 200316508938758174235 200421921225110753309854 2005398613161165400910476 2006734211571386246912354 2007910614881891258015065 20081014815702204513719059 20091168915641961395119165 2010139921588215252818260 20111343212982088216820 Total75704131231612525982130934

4. Explants Mfg.->AllM1M2M3PIP 200123898693437 200223794645821 2003326141807233 20045661289782259 200564420812790219 200660524811592150 200771933212289176 2008869365109115280 200964535766102120 201050137749669 201122515927372 Total557525079258371306

7. Observations ~5%  2% explant in first year in UK Nearly all PIP implants were elective. Early 2001- 2006 PIP were cohort with problems Manufacturer M2 will probably have problems US implants (except for Allergan) made in Brazil: Mentor (Santa Barbara, Irving, TX), Sientra- Silimed (Garland, TX), Hutchinson Implants and explant counts are statistically sufficient! – Send ships and returns counts to pstlarry@yahoo.com for reliability estimates, repairable or notpstlarry@yahoo.com