I ask this not only b/c of the cost, but the high odds of getting a false positive. Would it be dangerous to just wait until a symptom arose?, rather than go into a possible corrective surgery based on a false positive? What are the risks of letting a rupture be silent until it manifests into outward apparent symtoms? Do you think many patients even get these follow-up MRIs? Thankyou in advance for any and all responces.
I Am About to Get Silicone Breast Implants and I Am Wondering if Patients Actually Comply with the Followup MRIs?
Doctor Answers 12
MRI recommendations by the FDA for Silicone Breast Implant followup
Silicone gel implants were re-released on the market in November of 2006. With this approval came recommendations for Implant MRI's at 3-5 and 7 years post-augmentation. No one knows or has reported on the actual compliance rate of patients but I will be very surprised if it is over 5%. The FDA, implant manufacturers, plastic surgeons and particularly patients need an accurate, safe, cost effective alternative to MRI that are expensive and often not covered by insurance. In the ASJ the Aesthetic Surgery Journal in Feb of This year, we published the first article comparing Hi Resolution Ultrasound to MRI and the took the patients to surgery to determine the accuracy of the test. I found that Ultrasound was equally effective as MRI in determining breast implant shell failure. We have studied an additional 45 patients and Ultrasound continues to be equivalent and in 2 patients have found shell failures when the MRI's were read as negative. So essentially Hi Resolution ultrasound appears to be equivalent in followup of breast implants. Ultrasound has many advantages...much less expensive, widely available, not painful, can be used in anyone and appears equivalent in implant f/u. The main plastic surgery societies ASAPS and ASPS are in discussion with the FDA to see if the recommendation for the MRI requirement would be replaced with alternative technology such as ultrasound if shown to be equivalent in shell failure detection. If they will be open to a policy change, implant manufacturers will likely fund additional multicenter studies to prove equivalency. I have scanned over 250 patients and with an independent radiologist scanning my patients as well, are convinced the accuracy to MRI is equivalent. I am continuing to follow my breast implant patients, however am now using Ultrasound as the main determinant on implant replacement. I believe this is the future for implant followup although additional studies need to be performed independently to confirm and for the FDA to make a policy change in their current MRI recommendation.
Background: Magnetic resonance imaging (MRI) has historically been considered the “gold standard” for imaging silicone gel breast implants and is currently recommended by the US Food and Drug Administration for device surveillance. Recent studies, however, have questioned its accuracy as the best screening test for implant failure. In addition, the high cost of MRI is a significant deterrent to follow-up, especially among asymptomatic patients. Recent advancements in ultrasound technology have led to the development of high-resolution devices with the potential to accurately image breast implants and breast tissues. All my Best! Dr B
Objectives: The authors evaluate the feasibility of portable, high-resolution ultrasound (HRUS) for imaging of silicone gel breast implants and perform preliminary comparisons of HRUS to MRI in the assessment of both intact and failed implants in a clinical setting by both radiologists and plastic surgeons.
Methods: Phase 1 was composed of in vitro and ex vivo scanning model assessments in a variety of implant models utilizing multiple HRUS hardware platforms (GE LOGIQ-9, LOGIQ-e, LOGIQ-i, and Venue-40 devices) and transducer heads (range, 8-16 MHz, mainly GE12ML transducer). In Phase 2, these technologies were applied clinically to provide imaging experience in three patients previously diagnosed with unilateral implant failure. Phase 3 was a preliminary prospective evaluation of HRUS of 29 implants in 15 consecutive patients for whom MRI and independent surgeon-performed and radiologist-performed HRUS scans were compared to subsequent surgical findings.
Results: In Phase 1, all hardware models easily detected both intact and intentionally damaged shells in currently marketed fourth-generation responsive gel implants and in investigational, fifth-generation highly-cohesive gel devices. Although multiple transducers were able to detect shell failure, the 12-MHz head produced the best images at the normal clinical depth range. In Phase 2, confirmatory HRUS scans correctly identified the side of rupture and were consistent with MRI and surgical findings in all patients. In Phase 3, MRI, surgeon-performed HRUS, and radiologist-performed HRUS scans were all accurate in predicting implant shell integrity in 29 of 29 imaged breasts (100%) as confirmed at the time of surgery in both symptomatic and asymptomatic patients.
Conclusions: Preliminary results with a variety of base and transducer systems demonstrated that HRUS provides excellent visualization of current fourth- and fifth-generation silicone gel implants both in the in vitro and ex vivo scanning models. In vivo surgeon-performed HRUS accurately identified implant status and correlated with radiologist-performed HRUS, MRI, and surgical findings. An ongoing Phase 4 prospective study is under way to help define the sensitivity and specificity of HRUS technologies in the evaluation of current implant designs. However, the relative affordability, accessibility, availability, and dynamic real-time visualization provided by HRUS represent significant potential advantages of HRUS over MRI in both the screening and future diagnosis of breast implant shell failure.
Bengtson & Eaves
Wondering if Patients Actually Comply with the Followup MRIs
Since silicone implants were allowed back for general use, the FDA recommendation has been for MRI at 3 years after surgery, then every two years.
The basis for this recommendation was that leaks when they occurred were diagnosed less than one-third of the time by physical exam. (This is unlike saline leaks which are almost always obvious due to loss of volume.) What isn't clear was the harm that might be encountered by not making the diagnosis early. Most surgeons feel that the harm is minimal, but we may or may not be correct!
MRI's are not cheap ($2000 or so) and are usually not covered by insurers in this setting. Although I do note the FDA recommendation to my patients, I do not think many of them get the exams.
In nearly three decades of practice I am not sure I can recall a patient who was harmed by a delayed diagnosis of a gel implant leak.
Thank you for your question.
I would say that most do not get routine MRI's after breast augmentation with silicone gel implants.
To answer your question directly, I would say that most do not get routine MRI's. They are expensive and have a false positive rate. You may want to consider saving the money that you would spend on multiple MRI's and use the money when the day comes that one or both of your implants need to be replaced.
Discuss all options with your surgeon. Ultimately, your call.
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MRI screening after silicone breast augmentation
I do not believe that very many patients comply with the FDA recommendations for MRI screening. Nor do I personally believe that there is a medical risk in foregoing the MRI screening. Every surgeon will have a different spin on this question. Mine is this. I do believe that the MRI screening can be of some benefit. But not necessarily to the individual patient. I think that it is a way that the FDA can gather data about the longevity of the silicone implants. MRI screening is not needed for saline implants because there are no silent ruptures with saline implants. The durability and longevity of the implants is easily determined without a screening exam. Silicone implants are different. Rupture of the cohesive gel implants is most often unknown by both the patient and surgeon. MRI screening, in my opinion, is a way to gather data about the silicone implant and not a method that offers any safety or health benefit to the individual patient. I tell my patients what the FDA recommendations are and that I personally recommend considering an MRI if there are ever any changes to their breast exam. I have not seen any patients, nor heard of any, with any systemic health issues as a result of a ruptured silicone implant.
MRI recommendations with Silicone Implants
The FDA does recommend MRI after 3 years, then every other year. Although I share this recommendation with my patients, most do not follow it.
I would recommend that you continue to followup with your plastic surgeon as instructed and not wait until something happens to seek their attention.
Great question!! :))
Cost effect plan
For new patients, I tell them the FDA recommendation. I also suggest to them a better way to spend their money. At 3 years post op, do NOT get an MRI, but save the $1500 it would cost. Do it again at year 6, 9 and 12. You now have $6,000 and could pay for replacement of your implants if you were worried about leakage. This would start the time clock on the implants over again. I also tell them it is fine to wait 15, 18, or more years if they are not having problems. I suspect most plastic surgeons tell patients the FDA guidelines, but find them excessive.
MRI study after Silicone Gell Breast Implants and Compliance?
Thank you for the question.
The majority of my patients do not get the follow-up MRIs as recommended by the FDA.
MRI after silicone implants
MRI after silicone implants
The FDA recommends that an MRI should be performed three years after surgery and every two years after to rule out an occult rupture. I tell this to my patients, but I think the reality is many will not do so because of the inherent cost of the MRI.
Do silicone implant patients actually get the MRI they are supposed to get?
This is a great question! The MRI recommendation from the FDA is to get an MRI to detect occult leakages 3 years after initial augmentation and then every 2 years. I tell all of the ladies in my practice considering silicone breast enhancement that this is the FDA recommendation. I list it on my consent forms to make sure they know and the implant companies have a book you should have received which also tells you to get the MRI.
The question that you ask is how many ladies actually do this? I have not seen any large number published data (yet) on this topic although it is one of the questions asked in the 2006 follow-up for approval studies. I find that in my practice many ladies actually do not get these MRIs. This is a patient choice.
Plastic Surgeons have spoken to the FDA (as recently as 2011) to discuss whether or not this suggestion to get MRI should even be in the package labeling. At this point the FDA says get the MRI. Many surgeons question if this is truly needed.
Until the FDA says don't bother getting an MRI, I am going to continue telling my patients that the FDA says to do it every 2 years.
I also inform patients about the downsides of MRI. They are very expensive and it is rare that an insurance company will pay for an elective cosmetic MRI. They have also been known to indicate possible leaks which lead to surgery when no leak is present. Being ultra sensitive they sometimes overcall leaks. Finally they are inconvenient and often embarrassing for ladies.
My own belief is that if any symptoms (or any change in the breast at all) arises, you need an MRI. As I believe that silicone is safe and will not hurt your body systemically even though it can cause local (breast) changes waiting is not going to cause a problem. Thus I do not tell my patients that they are making a mistake by waiting. Of course I am not comfortable telling you what to do without knowing your specific medical history so I would speak to your surgeon for direct medical device but this is what I commonly tell most of my patients.
Good luck on your upcoming surgery. I would tell you to discuss these concerns with your surgeon. I see you live in Berlin and if you have not selected a surgeon yet I am certainly happy to consult with you to discuss all of these topics. I discuss all of these things, especially this question you ask with my patients so I hope you have found a surgeon that discusses these things with his/her patients.
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.