Clinical research is really, really difficult!

That’s a lot of paper work!

I was doing some office spring cleaning the other day and came across two file boxes of patient charts from a breast implant study I participated in years ago. The study was the McGahn Silicone Breast Implant Adjuvant Study which was being conducted to gather information about the efficacy and safety of silicone gel breast implants which had been taken off the market in the early 1990’s. I enrolled 56 patients over about 9 years and had a study completion rate of about 80%. I remember how difficult it was to get patients to come in for follow-up although that was part of the agreement in order for a patient to participate. The follow-up was free but it still took phone calls, letters, e-mails and a little begging to get some patients to come in. During this study one of the new implants, the 153 anatomic gel, was found to have a very high early rupture rate and was quickly taken off the market. I had several patients with this implant that required removal and replacement but I had no other serious adverse events. I was happy to participate in this study even though it was a ton of work for me, my patients and my staff. It was many, many surgeons participating in studies such as this that lead to the new generation of gel implants being put back on the market and made available to patients for breast enhancement or reconstruction. Some groups that are pushing to have breast implants banned have criticized these clinic studies and have pointed out the less than perfect follow-up. I cannot speak for other study participants but we worked very, very hard to get our follow up number. I think that the difficulty of clinic studies is not appreciated by those who have not participated either as investigators or patients. And the think most of the lay public is clueless on this topic. I have done a lot of research in my career, mostly lab research in college, medical school and residency and mostly clinical in practice and I can say that I think lab research is a lot easier!

Thanks for reading! Dr. Lisa Lynn Sowder
Follow me on Instagram @sowdermd and@breastimplantsanity