Long-term safety and efficacy of breast biopsy markers in clinical practice

Figures & data

Figure 1. HydroMARK biopsy clip in their native forms (a) and after clip deployment (b)

Figure 2. MammoMARK/CorMARK biopsy clips in their native forms (a) and after clip deployment (b)

Table 1. Complete listing of available marker shapes, material composition, and introducer sizes in products studied

Product	Introducer gauge	Marker material	Marker shape
MammoMARK	8 and 11 gauge	Titanium	Bowtie shaped
MammoMARK	8 and 11 gauge	Titanium	U shaped
MammoMARK	10 gauge	Titanium	Bowtie shaped
MammoMARK	10 gauge	Titanium	U shaped
CorMARK	14 gauge	Titanium	Bowtie shaped
CorMARK	14 gauge	Titanium	U shaped
Hydromark	8, 9, 11, and 15 gauge	Titanium	Barrel Coil
Hydromark	8, 9, 11,15, and 18 gauge	Titanium	Open Coil
Hydromark	8, 9, 11, and 15 gauge	Titanium	Butterfly Coil
Hydromark	9 and 15 gauge	Titanium	Barrel Coil
Hydromark	8 gauge	Stainless Steel	Barrel Coil
Hydromark	9 and 15 gauge	Stainless Steel	Open Coil
Hydromark	15 gauge	Stainless Steel	Barrel Coil

Table 2. Highlighting the types of image-guided biopsies performed. Note: Percentages are among each marker

Markers	Total biopsy marker deployed N	Sonographic guidance n (%)	MRI guidance n (%)	Stereotactic core biopsy n (%)
MammoMARK	115	66 (57.4)	19 (16.5)	30 (26.1)
CorMARK	269	269 (100.0)	0 (0.0)	0 (0.0)
HydroMARK	384	333 (86.7)	0 (0.0)	51 (13.3)
Total	768	668 (87.0)	19 (2.5)	81 (10.5)

Table 3. Summary of identified device deficiencies and adverse events

Device	Type of event	Description
CorMARK	Device Deficiency type: User Error	User failed to deploy marker properly per device use instructions which led to failure to properly deploy.
HydroMARK	Device Deficiency type: User Error	Misplacement of marker relative to target.
HydroMARK	Device Related Non-serious Adverse Event	Missing marker following explantation