AJR 2005; 185:203-206
© American Roentgen Ray Society
Delayed Migration of Gel Mark Ultra Clip Within 15 Days of 11-Gauge Vacuum-Assisted Stereotactic Breast Biopsy
Jay R. Parikh1
1 Women's Diagnostic Imaging Center, Swedish Cancer Institute, 1221 Madison St.,
Arnold Pavilion, Suite 520, Seattle, WA 98104.
Received July 13, 2004;
accepted after revision August 26, 2004.
Author is current nonpaid member, Scientific Advisory Board, Hologic, and
former paid consultant, Ethicon Endo-Surgery.
Address correspondence to J. R. Parikh
(jay.parikh{at}swedish.org).
Introduction
Interventional breast radiologists commonly deploy metallic clips in
the biopsy site after percutaneous vacuum-assisted stereotactic breast biopsy.
Cases of delayed clip migration have been reported
[1-6]
for the MicroMark clip (Ethicon Endo-Surgery) and Gel Mark clip (SenoRx). To
my knowledge, I am reporting the first case of delayed migration of the Gel
Mark Ultra clip (SenoRx), which occurred within 15 days of initial accurate
placement as confirmed by mammographic imaging. Sonogram-guided localization
of the bioresorbable pellets enabled accurate surgical excision at the core
biopsy site. Radiology-pathology correlation demonstrated that despite delayed
migration of the clip, the majority of the pellets stayed near the core biopsy
site, providing a reliable landmark for localization.
Consultation with the institutional review board revealed that neither
their approval nor informed patient consent was required for this case
report.
Case Report
A 62-year-old woman with a history of focal ductal carcinoma in situ
treated in the right breast 10 years previously with lumpectomy underwent
percutaneous stereotactic-guided core needle biopsy for indeterminate
calcifications and associated density at 12 o'clock in the left breast. The
left breast biopsy was done in a 90-degree lateral-to-medial approach with an
11-gauge vacuum-assisted biopsy device (Mammotome, Biopsys/Ethicon
Endo-Surgery), as the lesion was readily identified in the lateral projection
during mammographic workup, but difficult to visualize in the craniocaudal
view. No significant bleeding occurred during or immediately after the biopsy.
After removal of the bulk of the calcifications during core biopsy, a Gel Mark
Ultra clip was deployed into the biopsy cavity.
Postprocedural mediolateral oblique images followed by craniocaudal
mammographic images (Fig. 1)
confirmed initial accurate clip placement at the biopsy site. Histology showed
infiltrating lobular carcinoma and atypical ductal hyperplasia associated with
microcalcifications in the core biopsy specimens. The patient was informed of
the malignant histology by the interventional breast radiologist 2 days after
biopsy and referred for surgical consultation. She reported no pain, bleeding,
or swelling at the biopsy site.
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Fig. 1 —Immediate postbiopsy craniocaudal film-screen mammogram in
62-year-old woman with previous history of ductal carcinoma in situ in the
right breast shows Gel Mark clip (SenoRx) (solid white arrow) within
biopsy site, as denoted by adjacent density from small hematoma (hollow
white arrow). Air radiolucency (solid black arrow) is noted near
stereotactic needle entry site in lateral breast.
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The patient returned 15 days after initial stereotactic biopsy for surgical
lumpectomy. Using sonographic guidance (HDI 5000 with SonoCT; Advanced
Technology Laboratories), the bioresorbable pellets were localized
[7] under local anesthesia with
a Modified Disposable Kopans Spring Hook Localization Needle (Cook)
(Fig. 2). Postprocedural true
lateral and craniocaudal mammographic images
(Fig. 3) confirmed successful
placement of the reinforced segment of the wire in close approximation to the
region of the initial biopsy cavity. However, the clip had migrated 4 cm
laterally from the biopsy site. After informed consent was obtained from the
patient, the clip was successfully localized with a second Modified Disposable
Kopans Spring Hook Localization Needle using full-field digital mammographic
guidance. Postprocedural craniocaudal and mediolateral oblique full-field
digital mammographic images (not shown) confirmed successful placement of the
reinforced segment of this second wire adjacent to the clip.
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Fig. 2 —With sonogram guidance, antiradial real-time compound breast
sonogram image of left breast at 12 o'clock position shows needle localization
wire (solid white arrows) placed into region of Gel Mark Ultra
pellets (Seno Rx) (hollow white arrows) within recent stereotactic
biopsy cavity.
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Fig. 3 —Initial preoperative needle localization craniocaudal
mammogram shows localization wire to be in region of biopsy cavity; minimal
hematoma is present (hollow arrow). Skin entry site of hookwire is
denoted by round metallic BB placed on breast. Gel Mark clip (SenoRx)
(solid white arrow) has laterally migrated with respect to biopsy
site. Ill-defined density (solid black arrow) is present in mammogram
from injected local anesthesia.
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At surgery, the lumpectomy specimen radiograph (Figs.
4A, and
4B) confirmed the presence of
the two hookwires and the clip. Carefully directed sectioning by the
pathologist showed the malignancy and changes of the recent biopsy site to be
in close approximation to the biodegradable pellets. The pathologic section
containing the clip did not contain any features of the recent core biopsy.
Surgical specimen histology showed residual malignancy separate from the
margin. The patient's postoperative course was uneventful.
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Fig. 4B —Mammogram specimen. Translucent material from pellets
(solid black arrow) within elongated space (black S) is
seen, representative of core needle biopsy cavity surrounded by fibrosis and
inflammation. In region of core biopsy site, pattern consistent with
infiltrating lobular carcinoma (not shown) was identified. After carefully
supervised sectioning by interpreting pathologist, no malignancy was found in
region of migrated clip.
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Discussion
The Gel Mark Ultra biopsy site marker system (SenoRx) consists of an
introducer containing 11 biodegradable cylindric pellets. The pellets consist
of a copolymer of polylactic acid and polyglycolic acid, the same basic
ingredients of a Vicryl suture (Ethicon Endo-Surgery). One of the pellets
contains a stainless steel clip (technical report #2, SenoRx). Immediately
after a stereotactic breast biopsy, the introducer system is placed into the
biopsy probe, and the pellets are deployed into the biopsy cavity in a slow
and steady manner. Embedded within the pellets are carbon dioxide bubbles that
make the marker highly echogenic and visible on sonography for at least 4
weeks [8]. This enables
sonographically-guided needle localization when necessary after stereotactic
breast biopsy [7]. The pellets
are ultimately degraded and resorbed, with the permanent metallic clip left
behind.
Delayed migration is an increasingly recognized complication of clip
placement, and refers to the shift of the marker location after initial
correct placement of the marker into the biopsy cavity. At least four cases of
delayed migration of the MicroMark clip within 5 weeks
[1], 6 weeks
[2], 10 months
[3] and 1 year
[4] of accurate initial
placement have been reported. Similarly, delayed migration of the Gel Mark
clip within 8 days [5], 15 days
[6], and 10 weeks
[1] of initial accurate
placement has been reported.
To my knowledge, this is the first report of delayed migration of the Gel
Mark Ultra clip, which occurred within 15 days of initial accurate placement
confirmed by mammographic imaging.
The delayed migration of the Gel Mark Ultra clip in this case was along the
axis of the insertion of the biopsy needle (i.e., the Z-axis). This
has been postulated to occur from the accordion effect
[9]. In theory, immediately
after the core biopsy, the clip is within the biopsy cavity but does not
adhere firmly to the breast tissue. When the breast is released from
compression after stereotactic biopsy, the metallic-clip shift from the biopsy
site occurs along the trajectory of the biopsy needle, presumably the axis of
least resistance. Other possible mechanisms of clip migration include simple
migration of the clip in fatty tissue, bleeding during or after the procedure
displacing the clip, and resorption of postbiopsy air
[9].
In this case, preoperative sonographically-guided needle localization of
the pellets [7] enabled
successful surgical excision of the core biopsy site and malignancy, despite
clip migration. Initial postprocedure mammographic images confirmed the
localization hookwire to be adjacent to the biopsy cavity, whereas the clip
had migrated 4 cm from the core biopsy site. Radiologic-pathologic correlation
demonstrated that the majority of pellets had stayed within the biopsy cavity,
whereas the metallic clip had migrated. Based on this experience, radiologists
should consider sonographically-guided localization of the Gel Mark Ultra clip
a viable option compared with mammographic guidance. This approach may be
especially helpful in the settings of clip migration and/or mammographic
disappearance of the initial lesion after stereotactic core needle biopsy.
Further research is needed to assure that the sonographically visible pellets
do not migrate.
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Introduction
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