Table J11 - US and MRI Assessment of integrity of silicon breast implants

A Evidence based guidelines - the evidence base for MRI and ultrasound scanning to assess the integrity of breast implants

Evidence Table J11 - US

Assessment of integrity of breast implants by US and MRI

A	Clinical Problem	Assessment of integrity of silicon breast implants
A1	Ref No. in MBUR4 (if any)	J11 - US and MRI
A2	Section in MBUR4	Breast disease
B	Search strategy: databases used; period; MeSH headings; other key words.	Medline 1966-2000, Embase 1988-2000, hand search relevant journals and publications; breast implants, magnetic resonance imaging, ultrasound.
C	Search results: no. found; no. used.	Found 69; used 4
D	Reference numbers of cited references in attached master list.	J11 1-5
E	Summarised results from each of the cited references	Weinreb and Newstead (J11,1) considered u/s useful for diagnosing palpable breast masses and determining whether the origin is breast or implant. Venta et al (J11 2) performed u/s on 78 implants with subsequent surgical correlation and obtained a negative predicted value for rupture of 91%. Lori Brown et al (J11 3) compared published series on imaging modalities and found MRI substantially more sensitive (up to 98%) in the detection of rupture than mammography or u/s. Hilbertz and Patt (J11 4) concluded that MRI should be the ìgold standardî for imaging breast implants for suspected rupture as their review of the literature demonstrated sensitivities of 90-95% and specificities up to 100%.
F	Statement (= the conclusion drawn from E)	Ultrasound examination may be helpful in diagnosing palpable masses and a normal u/s examination is highly predictive of an intact implant. MRI more sensitive for comprehensive evaluation
G	Evidence level of F classified I - IV	2
H	Investigation	Breast Ultrasound and MRI
I	Recommendation *	Specialised examination
J	Grade of Recommendation A - C	B
K	Comment (if any) to go in booklet version of MBUR5	Ultrasound is quick and simple and a normal US is highly predictive of an intact implant. Symptomatic women with implants > 10 years old and positive US have a 94% probability of rupture. MRI can reasonably be used for confirmatory testing in other subsets.
L	Any other comments on this problem (e.g. caveats; suggestions for research or systematic review; cost or opportunity cost; users' views.	Janet Litherland, Carolyn Cordiner, Caroline Rubin and Mary Briley

Comments: The assessment of integrity of breast implants or coincident masses requires specialist skills and facilities. Ultrasound is quick and simple and a normal US is highly predictive of an intact implant

References: -

Ref ID	Author; Year; Country; Grade (I-IV).	Aims	Patient population	Study design*	Results
J11 1	Weinreb JC 1995 USA II	Assessment of MRI imaging of silicon breast prostheses		Review	Ultrasound useful for detecting origin of palpable mass (ie. breast or implant). MRI preferable for comprehensive evaluation.
J11 2	Venta LA 1996 USA II	Evaluation of u/s as a screening tool for implant rupture	Evaluation of 78 implants with surgical correlation	Prospective	Normal result highly predictive of intact implant (negative predicted value 91%).
J11 3	Lori Brown S 1997 USA II	Comparison of published data on imaging techniques for implant rupture		Review	MRI more sensitive for detection of rupture than mammography or u/s. Sensitivity if MRI up to 98%; specificity up to 93%.
J11 4	Hywang-Kobrunner SH (Chapter authors: Hilbertz T and Patt R) 1995 Germany II	Review of imaging of implant failure by MRI		Review	MRI sensitivity for rupture 90-95%; specificity up to 100%
J11 5	Chung KC 1998 USA II	Derivation of diagnostic algorithm for u/s and MRI for implant rupture using Bayesí theorem		Review	Asymptomatic women with normal u/s have probability of rupture of 2.2% Symptomatic women with implants >10yrs old and a positive u/s have a 94% probability of rupture. MRI can reasonably be used for confirmatory testing in other subsets.