The FDA has scheduled a hearing for August 30 and 31, 2011 to address the issue of post-approval long-term breast implant studies. In 2006, the FDA released silicone gel-filled breast implants back onto the market. As a condition of this release however, the agency required the two manufacturers of these devices, Allergan and Mentor, to conduct ongoing studies to collect data from patients for 10 years following implantation. These studies were intended to collect data on complication rates, risk of neurological disease and suicide, cancer rates, issues with mammography, and potential problems with lactation and reproduction. Additionally, the FDA strongly urged surgeons to recommend that patients undergo an MRI of the breast implants 3 years after the initial placement and then every two years thereafter. The intent of the agency I believe was to have ongoing monitoring of silicone gel-filled implants to try to capture any potential problems that may not have surfaced during the rigorous ten year duration pre-approval studies. They seem to be very concerned about the issue of "silent ruptures" of the devices which in many, and in fact probably most, cases generally goes undetected as long as the surrounding scar capsule is intact.
What the FDA doesn't seem to realize in my opinion, is that these proposals are a significant burden to patients and their surgeons. For the patients to come in to the office yearly to be checked and complete paperwork is not an insignificant inconvenience to the majority of implant recipients who are juggling child care and often a job simultaneously. Then to add insult to injury, they are requesting the patient get these MRI's which they would have to pay for out of pocket-- an expense that could easily run anywhere from $1200-$2000 every other year! It is my humble opinion that these bureaucrats are truly out of touch with the realities of these real world patients. On top of that, even if the patients got the requested MRI and there was an intracapsular (inside the capsule) leak suggested, I would not recommend removal at that point unless at some point the capsule tore and the gel escaped into the surrounding tissues. In my rather extensive experience, many women go for years with ruptured implants contained by the scar pocket without any problems.
My colleague Dr. Caroline Glicksman from the NY area has wisely suggested that the FDA consider some other less onerous methods of collecting information such as via an online questionnaire. I suspect the percentage of compliance would be much greater. I would hope that the FDA would rethink their request for the serial MRI's and recommend them only if the patient is in some way symptomatic.
I have worked extremely hard in my practice to reduce complications associated with breast implant surgery and to maximize good patient outcomes. At the same time I have always tried to be realistic and mindful of avoiding any undue inconvenience for my patients. It is my sincere hope that the FDA will do the same.
If you would like to offer your opinions on this topic to the Center for Devices and Radiological Health (CDRH), the FDA committee charged with oversight of breast implants, you can email your thoughts to them at the following address: http://www.regulations.gov