Makers of silicone breast implants have not followed up on thousands of women who have received them as required by health watchdogs as a condition of their approval.
Allergan Incorporated received FDA approval for their silicone gel filled breast implants in 2006 after agreeing to do wide spread 10-year post-market studies. In a two day meeting recently to update the FDA on the status of those trials, Allergan admitted that they had lost track of a large numbers of women after implantation. Mentor world wide who also manufactured silicone implants admitted the same.
Mentor’s study enrolled more then 40,000 patients but after 3 years had a follow up rate of only 21%. Allergan enrolled more than 39,300 with a follow-up rate of 60% after 2 years.
Speaking today, Liam Moloney, Healthcare Solicitor, said, “It is not standard care for breast implant patients to visit their plastic surgeons annually. Patients most likely to follow up with their doctors are those who experience complications. However, it is important that patients attend with their plastic surgeons regularly to ensure that the implants have not ruptured or are not Leaking”.
Mr Moloney continued “if any women have symptoms such as flu like symptoms, neck and shoulder pain, joint pain, dizziness or blurred vision, they should immediately return to their plastic surgeon so that the appropriate examination and scans can be carried out”.
Many implants come with a warranty that offers free replacement in case of rupture or deflation. It also may offer surgical cost assistance for replacement surgery. MRI scans also pick up about 90% of ruptures but as the procedure is costly many women fail to have them carried out.