For women with silicone gel breast implants, the FDA recommends an MRI examination to see if one or both of the implants may be ruptured. The first screening MRI is recommended 3 years after the implants are placed and then every 2 years after that. However, there is some controversy regarding the need for such frequent MRI studies and if the MRI exams are even useful in women who are not having any problems with their implants.
The FDA recommendations were made to detect broken silicone gel implants that do not cause any symptoms, known as “silent ruptures”. Plastic surgeons however questioned the need for frequent MRIs due to their high cost, questionable reliability, availability of other less expensive screening test and lack of any scientific evidence that such frequent MRIs will improve patient outcomes.
A publication by Dr. Colleen McCarthy in 2008 lead to the following conclusions:
Regular MRI has been recommended for the purpose of screening for silicone implant rupture. However, when its use as a screening test is critically examined, it appears that evidence to support its use is lacking. For example, there is no conclusive evidence at this time to show that using magnetic resonance imaging screening of asymptomatic women leads to a reduction in patient morbidity. Furthermore, based on existing data, it is unclear whether the potential benefits of screening magnetic resonance imaging tests outweigh the risks and potential costs for the patient. In the face of this uncertainty, shared medical decision making can be recommended. For different women, underlying beliefs and values will sway decision making in different directions. By engaging a woman in the process of shared medical decision making, however, the plastic surgeon and her or his patients can make a mutually agreeable choice that reflects the patient’s individual values and health preferences.
A more recent review looked at the use of MRI in screening for breast implant rupture and concluded:
Many of the published studies using magnetic resonance imaging or ultrasound to detect silicone breast implant rupture are flawed with methodologic biases. These methodologic shortcomings may result in overestimated magnetic resonance imaging diagnostic accuracy measures and should be interpreted with caution when applying the data to a screening population.
So what does this mean for women who have silicone gel breast implants, placed for cosmetic or reconstructive reasons, who were advised to have MRI studies after 3 years and every 2 years after that?
- Since breast implant rupture is unlikely in the first 5 years after implant placement, screening a patient without any signs or symptoms of implant problems at 3 years may not offer any benefit.
- As implant rupture is more likely after 8 to 10 years, it may be more reasonable to wait until that time for a screening MRI.
- If a patient desires an MRI, she should first consider what to do with the results of the study. For example, if she is not having any symptoms and is overall happy with her results, would she be willing to have the implants exchanged if the MRI suggests a rupture?
- The decision as to what to do when an MRI suggests an implant problem may get complicated as MRI studies are not 100% accurate and may suggest that an implant is ruptured when in fact it is not. This may lead to unnecessary surgery to remove or exchange an implant and may contribute to additional costs and risks.
Perhaps the best recommendation is for women to be aware of the FDA guidelines but also to have a discussion about the implications of the recommended MRI screening with their Board Certified plastic surgeon. While guidelines may often offer a sense of security, in a time of evidence based medicine, critical thinking and patient centered care needs to be accounted for also.
- Source: Plastic & Reconstructive Surgery, Volume 121, Page 1127, 2008 and Volume 127, Page 1029, 2011
- Copyright: Karol A. Gutowski, M.D., Chicago, IL, 2011