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Removal of etonogestrel contraceptive implants in the operating theater: Report on 28 cases

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We describe removal procedures for etonogestrel contraceptive implants in the operating theater. In addition, we discuss the management of removal of contraceptive implants that are difficult to palpate or are impalpable. We conducted a retrospective single-center case series analysis of Implanon removals conducted at a university hospital between January 2002 and April 2005. We analyzed case notes for 28 patients who had their contraceptive implant removed in the operating theater. Intermenstrual bleeding was the principal reason for removal (52.4%). Ten patients already had one attempted removal of their implant. Preoperative ultrasound localized the implant in all cases. Half of the removals were done under local anesthetic, with three cases progressing to general anesthesia (11%). Thirty percent of the implants had migrated from their initial implantation, 37% were in intramuscular tissue and 11% were in the humeral neurovascular sheath. The only postoperative complications were one small seroma and transient paresthesia in the territory of the ulnar nerve. The implant was not found in one case. The removal of an implant that is not palpable or difficult to palpate should take place in the operating theater following localization by ultrasound. Patients must be fully informed about the procedure, including its complications and the risk for failure.
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Original research article
Removal of etonogestrel contraceptive implants in the operating theater:
report on 28 cases
Eric Vidin, Olivier Garbin , Brice Rodriguez, Romain Favre, Karima Bettahar-Lebugle
Service de Gynécologie, SIHCUS-CMCO, 67300 Schiltigheim, France
Received 21 December 2006; revised 21 February 2007; accepted 27 March 2007
Abstract
Objectives: We describe removal procedures for etonogestrel contraceptive implants in the operating theater. In addition, we discuss the
management of removal of contraceptive implants that are difficult to palpate or are impalpable.
Design: We conducted a retrospective single-center case series analysis of Implanonkremovals conducted at a university hospital between
January 2002 and April 2005.
Materials and Methods: We analyzed case notes for 28 patients who had their contraceptive implant removed in the operating theater.
Results: Intermenstrual bleeding was the principal reason for removal (52.4%). Ten patients already had one attempted removal of their
implant. Preoperative ultrasound localized the implant in all cases. Half of the removals were done under local anesthetic, with three cases
progressing to general anesthesia (11%). Thirty percent of the implants had migrated from their initial implantation, 37% were in
intramuscular tissue and 11% were in the humeral neurovascular sheath. The only postoperative complications were one small seroma and
transient paresthesia in the territory of the ulnar nerve. The implant was not found in one case.
Conclusions: The removal of an implant that is not palpable or difficult to palpate should take place in the operating theater following
localization by ultrasound. Patients must be fully informed about the procedure, including its complications and the risk for failure.
© 2007 Elsevier Inc. All rights reserved.
Keywords: Contraceptive implant; Etonogestrel; Difficult removal; Ultrasound guidance
1. Introduction
The contraceptive implant Implanonk(Organon,
Puteaux, France) has been available in France since May
2001. The implant is a small cylinder that is 40 mm long
and has a diameter of 2 mm. It contains 68 mg of
etonogestrel, the active metabolite of desogestrel. It is
inserted subdermally in the upper medial aspect of the
nondominant arm. This mode of contraception lasts for
3 years and does not require any further patient compliance.
Many studies have demonstrated its efficacy, and some have
reported a Pearl index of zero [19]. In September 2005, the
Organon Laboratory reported sales of 400,000 implants in
France and of 1.5 million implants in Europe. Soon after
Implanonkwas launched in the market, physicians were
confronted with occasional difficulties with removing the
implant. The Organon Laboratory nominated a referral team
in each French town to deal with difficult retrievals. We
form one of those teams. The aim of this report was to
describe difficult removals in order to define the manage-
ment of implants when they are difficult to palpate or are
completely impalpable.
2. Materials and methods
We conducted a retrospective study at the gynecology
department of a university hospital (i.e., SIHCUS-CMCO).
We analyzed case notes for patients who had to have their
Implanonkremoved in the operating theater between
January 2002 and April 2005.
The data collected include each patient's age, the level of
experience of the physician who inserted the Implanonk, the
site of implantation, the time between implantation and
Contraception 76 (2007) 35 39
Corresponding author.
E-mail address: olivier.garbin@sihcus.fr (O. Garbin).
00107824/$ see front matter © 2007 Elsevier Inc. All rights reserved.
doi:10.1016/j.contraception.2007.03.012
retrieval, the patient's reason for removal, the level of
experience of the physician who attempted the removal, the
difficulties encountered at palpation, the information col-
lected during surgery (e.g., type of anesthesia, location of the
implant, difficulties during the operation and operative time),
postoperative complications and type of contraception used
after retrieval of the implant.
3. Results
Twenty-eight cases of Implanonkretrieval in the
operating theater were identified during the study period.
The mean age of the patients was 31±7.5 years (range, 20
44 years). Their mean body mass index was 23.1±4.9 kg/m
2
(range, 1733 kg/m
2
).
The implant was inserted by a French gynecologist in
8 cases, by a general practitioner (GP) in 4 cases, by a non-
French gynecologist in 3 cases, by a GP trainee in 1 case
and by a trainee in obstetrics and gynecology in another
case. This information was missing for 11 cases. Seven
implants were inserted in a hospital setting, and 11 were
inserted in a private practice office. This information was
missing for 10 cases.
The average time between insertion and removal of
Implanonkwas 22.8±12 months (range, 540 months).
The reasons given by the patients for having their implant
removed are listed in Table 1. The most frequently cited
reasons for Implanonkremoval because of side effects were
metrorrhagia in 52.4%, headache in 23.8% and weight gain
in 14.3%. In a third of cases, removal was performed because
the Implanonkhad reached the end of its period of efficacy
(8/21 cases).
Ten patients already had at least one attempted retrieval.
Eight of them underwent an unsuccessful removal in a
clinic, one had an attempt in the operating theater and
another patient had two attempts in the operating theater
(Fig. 1A and B).
A radiologist performed preoperative ultrasound with a
7.5-Mhz high-frequency probe. In two cases, identification
was difficult, with doubt about the presence of the implant in
one case. In that case, the blood level of etonogestrel was
detected and the patient underwent a magnetic resonance
imaging (MRI) scan. A second ultrasound examination
allowed us to locate the implant.
We were able to determine from the patient records that
15 implants were not palpable and that 11 were palpable
albeit with difficulty in the preoperative examination.
Seventeen patients (61%) had local anesthesia initially;
however, for three of them, it was necessary to proceed to the
use of general anesthesia. Eleven patients had general
anesthesia initially (39%). The average length of the
procedure was 21.5±19 min (range, 570 min) for the
11 cases for which the information was available (mostly for
patients who had general anesthesia).
During the surgical procedure, we found that 19 implants
had not migrated from their initial implantation. Eight
implants did migrate outside the original site (30%),
including 1 that moved to the root of the axillary area. One
set of notes did not contain this information. Fourteen
implants were in a subdermal position, and more than a third
(11/28) were in an intramuscular position, most often under
the muscular aponeurosis. Three implants were located in a
Table 1
Reasons given by the patients for having their etonogestrel implant
removed
Reason n(%)
Metrorrhagia 11 (52)
Beyond expiry time 8 (38)
Headache 5 (24)
Weight gain 3 (14)
Spotting 2 (9.5)
Oligomenorrhea 1 (5)
Irritability 1 (5)
The total exceeds 100% because several reasons could have been cited by
the same patient.
Fig. 1. (A) Unsightly scars after two failed attempts at removing Implanonk.
The scars are distant from the Implanonk, whose position is marked by a
dark line on the skin and which was identified by ultrasound. (B) Immediate
postoperative appearance in the same patient. The implant was removed by a
small transverse incision.
36 E. Vidin et al. / Contraception 76 (2007) 3539
perivascular position, near or touching the brachial artery
(11%). Of the 27 cases for which the implant was retrieved in
the operating theater, only 5 were documented as being
difficult to retrieve. In one case, in which the Implanonkwas
in a deep intramuscular position, the implant was not found
and left in place.
The postoperative complications were a 2-cc seroma,
which necessitated drainage, and paresthesia in the ulnar
nerve area, which spontaneously resolved within 72 h.
The types of contraception chosen after removal of the
implant were the combined oral contraceptive pill in seven
cases, a progestogen-releasing intrauterine system in two
cases, a copper-bearing intrauterine contraceptive device in
one case, the progestogen-only contraceptive pill in one
case and high-dose progestogen administered intramuscu-
larly in another case. Four patients asked for a new
Implanonkto be inserted.
4. Discussion
With a Pearl index of 0.006 (range, 0.0040.08),
Implanonkis a safe and reliable method of contraception
[9]. Nevertheless, there can be problems with retrieving the
implant. Removal may be necessary because the implant is
no longer effective after 3 years (2.5 years in the case of
obese women) or because of side effects.
Having irregular menstrual cycles is the most common
reason triggering patients to request for early removal of their
Implanonk[3,10,11]. Affandi [10], in a Europe-based meta-
analysis, reported a rate of 23% for removing the Implanonk
within 2 years of its insertion for irregular cycles.
Intermenstrual bleeding was the principal cause of implant
removal (50% of cases). In France, Sergent et al. [3] reported
abnormal cycles in 83% of 182 patients with an Implanonk.
In this study, intermenstrual bleeding was the main cause of
premature removal of the implant (41% of 29 premature
removals). Irregular cycles seem to be less frequent in Chile
and Southwest Asia [6,10]. Our removal rate due to
intermenstrual bleeding is approximately 50%, which is in
keeping with rates reported in most of the occidental
literature. Other patients required removal of the implant
because of other well-known side effects: headache, weight
gain and irritability. Weight gain and irritability are due to
the androgenic activity of the etonogestrel and, along
with acne, are the most often reported side effects after
irregular cycles [7,12,13].
If a patient wishes so or after 3 years of use, Implanonk
must be removed from the arm because it is not biodegrad-
able. It is correct insertion in a good subdermal position that
will determine the implant's ease of removal. Usually,
removal is performed in a clinic by palpating the implant and
making a 2-mm incision at its caudal end and then pushing
the implant toward the incision. One end will come out and is
grasped with forceps/clips this is known as the pop-out
technique [14]. It is recommended to inject the local
anesthetic under the implant to avoid its disappearance
under the edema after the infiltration.
Times for removing an Implanonkare short according
to the literature between 2.1 and 5 min [6,7]. A meta-
analysis compared the length of time of removing
Implanonk(633 patients) with that of removing Norplantk
(137 patients), which is a similar but older levonorgestrel-
based device and that which includes six elements to insert.
The mean time for the removal of Implanonkwas 2.6 min,
versus that of 10.2 min for the removal of Norplantk[15].
Data regarding difficult retrievals of Implanonkare rare.
For Sergent et al. [3], 10 of 29 removals under local
anesthesia were deemed to be difficult by the patients. Two
were ultimately performed under general anesthesia. Affandi
et al. [6] reported on one difficult case from among 200,
whereas Croxatto et al. [7] did on 19 of 205 cases (3%).
One case of difficult localization of Implanonk, neces-
sitating ultrasound, computed tomographic scan and MRI,
triggered a national pharmacovigilance survey in France [16].
In 16 months, 11 cases of difficulty with or failure of
Implanonkremoval were reported, giving an incidence of
1/100,000 implants (range, 0.050.181). Only 9 of the
implants were finally removed, 2 of them under general
anesthesia. To our knowledge, our series is the largest
published to date concerning removal of Implanonkin the
operating theater. However, it has the obvious limitations
of retrospective descriptive studies.
An impalpable implant must trigger three questions: Has
it really been inserted? Is it in a subdermal or a subcutaneous
or intramuscular position? Has it migrated? The noninserted
implant is responsible for 77% of pregnancies occurring with
Implanonk[16]. In our experience, two patients were
referred for an impalpable implant and were in the first
trimester of their pregnancy. In these two cases, medical
Fig. 2. The implant is best visualized by ultrasound on a transverse plane as
an echogenic spot (white arrow) with a hypoechogenic shadow. The implant
is in a deep intramuscular position. Note the close position of the brachial
pedicle (black arrow).
37E. Vidin et al. / Contraception 76 (2007) 3539
imaging did not help with visualization of the implant. If in
doubt, the etonogestrel blood level can be determined to
confirm the presence of an implant. When present but not
palpable, the device can be difficult to locate with medical
imaging as it is radiotransparent [9]. This type of problem
was already encountered with Norplantk[9,17]. Ultrasound
using a 7.5-Mhz linear probe allows for identification of the
Implanonk, thanks to the presence of posterior acoustic
shadowing [18] (Fig. 2). It has been suggested that the
procedure be conducted in the ultrasound room, having
marked the site on the skin, to facilitate the retrieval of
the implant. This would avoid the difficulties caused
by changing the position of a patient when she moves
rooms [19]. For some authors, MRI is the best diagnostic
tool for locating an implant not seen with ultrasound [20,21].
It should be noted that the implant is only visible with low-
signal MRI.
Impalpable implants may trigger medicolegal actions.
Difficult retrievals of Norplantkwere responsible for a drop
in its use in the United States, following patient complaints
[22,23]. In 2003, in France, two gynecologists and a GP had
to utilize their professional insurance because they were
being sued for badly positioning implants [24]. In 2004,
three gynecologists and two GPs had similar experiences
[25]. No complaint was made by any patient in our series. It
is paramount to inform every patient when retrieval takes
Fig. 3. Removal of an intramuscularly positioned implant near the brachial pedicle. (A) The implant was identified by ultrasound, and the skin was marked. After
transverse skin incision across the implant, the aponeurosis was exposed. (B) Muscular exposure after aponeurosis incision. (C) Identification of the brachial
pedicle. (D) The implant was more lateral, in an intramuscular position. (E and F) Removal of the implant.
38 E. Vidin et al. / Contraception 76 (2007) 3539
place in a theater about potential difficulties and the risks for
failure and scarring.
Once identified, an incision of 1215 mm transverse to
the implant is made (Fig. 3). This is performed near the most
superficial end, which needs to be identified by the
radiologist. The incision may need to be longer when the
implant is deeper or near the humeral pedicle. The material
required is not specific, but small retractors, such as Farabeuf
retractors, may prove to be very useful. It is necessary to cut
the subcutaneous tissue, and the incision of the muscular
aponeurosis may often be necessary. The implant is often
located just underneath it. In cases of deeper location,
dissection needs to be progressive and gentle through the
muscular fibers. The use of a right-angle retractor may be
helpful, as is palpation with the pulp of the little finger in the
incision. Insertion within the muscle is unusual. The
dissection needs to be conducted carefully because of
the presence of arteries and nerves, which appear white,
like the implant.
It is worth noting that in the United Kingdom, the
doctors allowed to insert and remove the implant must be
specifically certified and their certificate needs to be
renewed every 5 years [26].
5. Conclusions
Removal of an impalpable or barely palpable implant
must be performed in the operating theater after localizing
the implant using ultrasound. Patients must be fully informed
about the procedure, including its complications and the risk
for failure.
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39E. Vidin et al. / Contraception 76 (2007) 3539
... Complications of implant insertion and removal occur infrequently [2]. Case reports and case series have addressed the complications associated with insertion and removal procedures [3][4][5][6][7]. This case report will support healthcare providers regarding specialist referral if there are any difficulties/complications related to implant removal, such as impalpable contraceptive implants, abnormal sensations, or persistent pain at the implantation site or in the arm and hand on the same side, as removal-related complications are often anticipated with the aforementioned conditions [2,8]. ...
... Many studies on complications related to implant insertion and removal have suggested that proper training for implant insertion is crucial and should be routinely performed, even though the Nexplanon applicator is designed for simpler and easier insertion. Besides, complications associated with implant insertion and removal have led to lawsuits in several countries [4,16]. ...
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Nexplanon is an etonogestrel contraceptive implant that comes with an applicator, making it easier to insert and remove. Complications related to insertion and removal procedures, such as neural-vascular injuries, are rare. We describe a case of reversible median nerve neuropathy and local muscle irritation resulting from blind removal attempts of an iatrogenically migrated implant. The patient presented with an unusual pain at the surgical site along with abnormal sensations and numbness in her left hand that worsened after blind attempts to remove the implant. Radiographs revealed that the rod was 3 cm from her insertion scar and deeply embedded in her left arm. The patient then underwent left arm exploration and implant removal under fluoroscopic guidance by an orthopedic surgeon. The rod was placed intramuscularly, adjacent to the median nerve under the basilic vein. The abnormal sensations and numbness in her left hand could be attributed to median nerve involvement, while the atypical pain at the surgical site could be a result of local irritation from the intramuscularly migrated implant from attempts at removal. The symptoms gradually resolved after surgery. This indicates that patients with impalpable contraceptive implants should be referred for implant removal by specialists familiar with the procedure to prevent further deterioration of adjacent structures from iatrogenic implant migration.
... Complications of implant insertion and removal occur infrequently [2]. Case reports and case series have addressed the complications associated with insertion and removal procedures [3][4][5][6][7]. This case report will support healthcare providers regarding specialist referral if there are any di culties/complications related to implant removal, such as impalpable contraceptive implants, abnormal sensation, or persistent pain at the implantation site, as removal-related complications are often anticipated with the aforementioned conditions [2,8]. ...
... Many studies on complications related to implant insertion and removal have suggested that proper training for implant insertion is crucial and should be routinely performed, even though the Nexplanon applicator is designed for simpler and easier insertion. Besides, complications associated with implant insertion and removal have led to lawsuits in several countries [4,16]. ...
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Full-text available
Nexplanon is an etonogestrel contraceptive implant that comes with an applicator, making it easier to insert and remove. Complications related to insertion and removal procedures, such as neural-vascular injuries, are rare. We describe a case of median nerve neuropathy resulting from blind removal attempts of an iatrogenically migrated implant. The patient presented with an unusual pain and an abnormal sensation in her left arm that worsened after blind attempts to remove the implant. Radiographs revealed that the rod was 3 cm from her insertion scar and deeply embedded in her left arm. The patient then underwent left arm exploration and implant removal under fluoroscopic guidance by an orthopedic surgeon. The rod was placed adjacent to the median nerve under the basilic vein. The symptoms gradually resolved after surgery. This indicates that patients with impalpable contraceptive implants should be referred for implant removal by specialists familiar with the procedure to prevent further deterioration of adjacent structures from iatrogenic implant migration.
... Patients may present for removal for a number of reasons, such as weight gain, desire to become pregnant, or unfavorable bleeding pattern. 2 The device is typically removed in an outpatient setting by manipulating the rod out of a perpendicular incision made at the distal end of the implant after injection of local anesthetic. When the practitioner cannot successfully remove the implant, however, the patient may be referred to a specialized center with family planning expertise 3,4 or an upper extremity surgeon for surgical removal. 2 Prior case reports have described proximal migration of the device into the axilla, 5 in the deep compartments of the arm, and even into pulmonary vasculature. ...
... When the practitioner cannot successfully remove the implant, however, the patient may be referred to a specialized center with family planning expertise 3,4 or an upper extremity surgeon for surgical removal. 2 Prior case reports have described proximal migration of the device into the axilla, 5 in the deep compartments of the arm, and even into pulmonary vasculature. [6][7][8] Factors associated with difficult removals include weight gain and longer duration of device placement. ...
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Purpose: Etonogestrel subdermal implants are a commonly used contraceptive device placed in the medial upper arm. Plastic and orthopedic surgeons may be consulted for difficult implant removals. We performed a case-control study comparing patients undergoing surgical and uncomplicated in-office removal at our institution. Patients and methods: We identified patients who underwent operative removal of implantable contraceptive devices by plastic or orthopedic surgeons at our institution from January 2014 to October 2019. Patients who underwent uncomplicated office removal during the same time were compared. Demographic and surgical variables were collected, and descriptive statistics were calculated. Univariate and multivariate logistic regression was performed with surgical versus outpatient removal as the outcome of interest. Results: A total of 669 patients undergoing etonogestrel subdermal implant removals were identified during the five-year study period, of which thirteen patients required surgical removal (1.9%) and 326 were selected as uncomplicated removal comparisons. There were no significant differences in median (IQR) body mass index (BMI) (31.1 [28.2, 35.2] versus 29.3 [24.0, 35.1], p = 0.19), median (IQR) weight gain since device placement (5 [-0.6, 14.7] kilograms versus 1.6 [-1.2, 5.8] kilograms, p = 0.15), or length of time since device insertion (2.3 [0.8, 2.8] years versus 1.0 [0.4, 2.2] years, p = 0.17). Of those who needed surgical removal, the most common indication for implant removal was device expiration (n = 5, 38.5%). Devices placed by OBGYN attendings were less likely to require surgical removal (p = 0.02). Family medicine attendings were more likely to refer patients for surgical removal (p = 0.02). No significant findings were detected on univariate or multivariate regression. Among surgical removals, radiography was the most frequently used imaging modality. Implants were most frequently subdermal (n = 11, 84.6%) though intramuscular placement was also identified (n = 2, 15.4%). Only one patient had residual paresthesia along the length of the incision. No other complications were identified. Conclusion: We did not identify risk factors associated with the difficult removal of etonogestrel subdermal implants. Practitioners should consult upper extremity surgeons if they encounter difficult removals.
... The implant is easily located by its posterior acoustic shadow [24]. The most common procedure is for the radiologist to draw a skin landmark before the surgical extraction [21,23,[25][26][27]. However, surgery involves soft-tissue dissection and a mean 15-20-mm incision for subfascial implants [23] and may still end up in failure in difficult cases [28]. ...
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Objectives The aim of this study was to assess the feasibility, performance, and complications of a non-surgical, minimally-invasive procedure of deep contraceptive implant removal under continuous ultrasound guidance. Methods The ultrasound-guided procedure consisted of local anesthesia using lidocaine chlorhydrate 1% (10 mg/mL) with a 21-G needle, followed by hydrodissection using NaCl 0.9% (9 mg/mL) and implant extraction using a Hartmann grasping microforceps. The parameters studied were the implant localization, success and complication rates, pain throughout the intervention, volumes of lidocaïne and NaCl used, duration of the procedure, and size of the incision. Between November 2019 and January 2021, 45 patients were referred to the musculoskeletal radiology department for ultrasound-guided removal of a deep contraceptive implant and were all retrospectively included. Results All implants were successfully removed en bloc (100%). The mean incision size was 2.7 ± 0.5 mm. The mean duration of the extraction procedure was 7.7 ± 6.3 min. There were no major complications (infection, nerve, or vessel damage). As a minor complication, 21 patients (46.7%) reported a benign superficial skin ecchymosis at the puncture site, spontaneously regressing in less than 1 week. The procedure was very well-tolerated, with low pain rating throughout (1.0 ± 1.5/10 during implant extraction). Conclusions Minimally invasive removal of deep contraceptive implants under continuous ultrasound guidance alone is feasible, effective, and safe. In the present cohort, all implants were successfully removed, whatever the location, with short procedural time, small incision size, low pain levels, and no significant complications. This procedure could become a gold standard in this indication. Key Points • Minimally invasive removal of deep contraceptive implants under continuous ultrasound guidance alone is feasible, which led to a success rate of 100% whatever the location (even close to neurovascular structures), with only a small skin incision (2.7 ± 0.5 mm). • The procedure was safe, quick, without any major complications, and very well tolerated in terms of pain. • This minimally invasive ultrasound-guided procedure could become the future gold standard for the removal of deep contraceptive implants, as an alternative to surgical extraction, even for implants in difficult locations such as subfascial ones or those close to neurovascular structures.
... Intraoperative US (IOUS) has become increasingly common across a wide range of specialties since its introduction in 1961 to facilitate the detection of renal calculi [2]. It has since been used within the field of gynecology to facilitate various operations from procedures as minor as removing a lost contraceptive implant [3][4][5] or intrauterine device [6], to more complex, invasive procedures including surgical termination of pregnancy, hysteroscopy and laparoscopic myomectomy [7][8][9]. More recent developments in US technology have resulted in greatly enhanced image quality and real-time IOUS has become increasingly utilized within the gynecological setting. ...
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Ultrasound is a readily available, safe and portable imaging modality that is widely applied in gynecology. However, there is limited guidance for its use intra-operatively especially with complex gynecological procedures. This narrative review examines the existing literature published on the use of intraoperative ultrasound (IOUS) in benign gynecology and in gynecological oncology. We searched for the following terms: ‘intraoperative,’ ‘ultrasonography,’ ‘gynecology’ and ‘oncology’ using Pubmed/Medline. IOUS can minimize complications and facilitate difficult benign gynecological procedures. There is also a role for its use in gynecological oncology surgery and fertility-sparing surgery. The use of IOUS in gynecological surgery is an emerging field which improves visualization in the surgical field and aids completion of minimally invasive techniques.
... From Norplant® to Nexplanon®, tremendous improvement has been made to combat the complications during removal of non-degradable implants at the end of treatment. Nevertheless, challenges still exist during implant removal [109]. Median and ulnar nerve injury have been reported while removing these non-degradable devices [110,111]. ...
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... Despite symptoms related to implant migration are rarely described, worldwide growing use of subdermal contraceptive implants makes this complications more and more studied and prevented (31)(32)(33). For this reason subcutaneous contraceptive implant migration represents a debated topic in current obstetrician and gynaecological oriented literature. ...
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Subdermal contraceptive implant is approved in more than 60 countries and used by millions of women around the world. Although relatively safe in nature, their implantation and removal may be associated with potential complications, some of which may require surgical intervention. Two types of peripheral neurological complications are reported: complications related to compressive neuropathy caused by device decubitus and complications related to device improper removal. An healthy 35-year-old woman come to our attention for paresthesia from medial side of right elbow to fourth and fifth fingers. Tinel sign was positive on medial side of distal third of right arm, above the elbow, as well. Clinical history of patients revealed a subcutaneous placement of a etonogestrel implant 3 years before. Patients reported disappearing of tactile feeling of subcutaneous contraceptive implant since two months. At clinical examination, implant was not felt in its original subcutaneous place. X-rays control revealed its proximal and deep migration. Surgical exploration for subcutaneous contraceptive implant removal revealed it lying on the ulnar nerve. Patient referred immediate paresthesia disappearing after surgery. At 1 month follow up no motor or sensory alteration were evident. Removal of implants inserted too deeply must be carefully performed to prevent damages to nervous and vascular structures and it should be performed by operators who are very familiar with the anatomy of the arm. In case of chronic neuropathy caused by implant nerve compression only an appropriate patients information about rare but possible neuropathic symptoms related to device migration and a careful medical history collecting can avoid a mistaken diagnosis of canalicular syndrome.
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An open, multicentre study was performed to assess efficacy, safety and acceptability of the single-rod contraceptive implant Implanon®. The study involved 635 young healthy women, who were sexually active and of childbearing potential. The women were followed up every 3 months over the entire study period. Originally the study was designed for 2 years, but was extended to 3 years in a group of 147 women from two centres. Altogether, 21 centres in nine different countries participated. The average age of the women was 29 years (range 18–42 years), of whom 83.5% had been pregnant in the past. No pregnancy occurred during treatment with Implanon®, resulting in a Pearl Index of 0 (95% confidence interval: 0.0–0.2). In the first 2 years, 31% had discontinued the treatment. Of the 147 women in the study extension, nine discontinued (6%) treatment. Bleeding irregularities was the main reason for discontinuation during the first 2 years of use (17.2%) and adverse experiences in the third year (3.4%). Implant insertion and removal were fast and uncomplicated in the vast majority (97%) of cases. Return of fertility was prompt. In conclusion, Implanon® has excellent contraceptive action during its lifetime of 3 years. The safety profile is acceptable and not essentially different from progestogens in general.
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This review article summarises and describes four techniques for the removal of Norplant ®. There follows a detailed discussion of those factors, classified into four groups, which are likely to complicate Norplant removal.
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Objectives To estimate the exact satisfaction of women toward Implanon®, the sole contraceptive implant available in France. To clarify the indications of this type of contraception. Material and method Among a population of 182 women with Implanon® inserted in a same family planning service between May 22, 2001 and February 14, 2003, 108 women agreed to answer a questionnaire of satisfaction. Implants were inserted in one third of cases after childbirth, in another third after abortion. The average duration of use of the implant was of 16 months (2 in 24 months). Twenty-nine removals among the 108 insertions (27%) were recorded. Results Possibility of a long-term and easy -to-use contraception was the most common reason for choosing Implanon® (74% of the women). Eighty-one percent of the women were globally satisfied with Implanon® but one out of two women had side-effects. Only 62% of the women were ready to use it again. Adverse events were first, menstrual disturbance in 83% of the women, mainly amenorrhea (26%) and bleeding irregularity (40%). Bleeding irregularity was one of the main motives for discontinuing the implant in 41% of cases. Except weight gain present for 37% of patients, the other side-effects, even though they were frequent, were less often the reason for removal. Headache, acne, breast pain, mood and decreased libido were the main reasons for removal. Conclusion Implanon® has certainly a place among current contraceptive methods. Because of the frequency raised by adverse events and by their lower tolerance in Europe, this place has to remain limited to the incapacity of classic methods. Preinsertion counseling announcing Implanon®'s benefit and risk effects is necessary to minimize the early discontinuation rates.
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Implanon® is a single-rod contraceptive implant containing the progestin etonogestrel. Implants require insertion and removal by medical professionals. Detailed and unbiased counseling before insertion is essential, and should include contraceptive efficacy, insertion and removal procedures, and possible adverse events. Insertion and removal times have been measured in six open studies and in seven comparative studies in which Norplant® (the six-capsule levonorgestrel implant) was used as the reference product. In comparative studies, the mean time needed for insertion of Implanon was 1.1 min and removal took 2.6 min. Insertion as well as removal of Implanon was four times faster than with Norplant. Complications with insertion and removal are rare in the hands of medical professionals familiar with the techniques.
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Objective. – Describe the initiation and follow-up of Implanon® insertion in current office-based practice in France and estimate the rate and causes of early removals.Patients and methods. – A prospective cohort study of 1000 women having been inserted with Implanon® by a representative national sample of prescribers (gynaecologists and general practitioners) was designed. The follow-up period was 3 years and the enrolment was planned for 2 years starting July 2002 according to a naturalistic design.Results. – The results are related to an intermediate analysis describing the situation of the cohort at the date 31 December 2003. 872 women were enrolled, of whom 784 (89.9%) by gynaecologists and 88 (10.1%) by GPs. Implanon® was inserted in 691 (79.2%) and 360 (52.1%) had at least one follow-up visit at this date. The mean follow-up period after insertion was 10.5 months. 38 early removals were recorded (actuarial rate at 16 months of 8.8% [CI 95% 5.0–12.7]), integrating the distribution of follow-up duration and the assumption that women with no follow-up visit the still had device.Discussion and conclusion. – The estimated early removal rate was lower than the result of the meta-analysis of international clinical trials but this figure should be confirmed in the final analysis of the study.
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Objective. – Analysis of the results of a national pharmacovigilance study on Implanon®, a contraceptive implant containing 68 mg of etonogestrel.Patients and methods. – This survey concerns cases of pregnancies (contraception failures), of migrations and of insertion or removal problems with Implanon® reported to French Regional Drug Pharmacovigilance Centres and to Organon SA between May 2001 and September 2002.Results. – In France, 39 unintended pregnancies were reported over 17 months. The pregnancies were in 77% of cases (N=30) due to an insertion technique error (implant not found when pregnancy has been diagnosed). For 3 patients (7,6%), pregnancy was due to a failure of etonogestrel contraceptive effect, explained twice by its association with an enzymatic inductor drug. For 4 patients (10%), pregnancy was due to an untimely insertion (insertion after day 5 of menstrual cycle or woman already pregnant). For two patients, no information was available. The incidence of reported pregnancies in France is estimated at 0.359 / 103 implants [0.246–0.482], in accordance with a typical Pearl Index of 0.06 [0.04–0.08]. Twenty-eight suspected migrations (N=11), problems or failures in removal of the implant (N=11) and insertion difficulties (N=6) were notified, corresponding to an incidence of 0.257/103 implants [0.162–0.363].Discussion and conclusion. – Occurrence of pregnancy is possible with Implanon®, due to errors in the insertion technique (device not really inserted) or to a non-respect of the SPC recommendations (drug-drug interaction or untimely insertion). Insertion problems can lead to localisation problems (implant not visible by X-ray) then needing further tests and even harmful practice (removal under general anaesthesia). That is why a real and strict training is highly recommended to physicians.
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Thirty years ago, the International Committee for Contraceptive Research of the Population Council began sponsoring research into a long-acting implantable contraceptive device. Several progestins were considered for application in such a device, but levonorgestrel was ultimately chosen due to the nature of its pharmacodynamics, its high efficacy, and its low incidence of side effects. More than 60,000 women participated in worldwide clinical trials using levonorgestrel in implantable silastic rods, making Norplant the most thoroughly studied contraceptive agent prior to release upon the general market. US Food and Drug Administration approval was granted in December 1990, and since 1991, approximately one million US women have had the implants inserted and more than three million women worldwide have used Norplant. Norplant is marketed in the US by Wyeth-Ayerst Laboratories and the silastic component of the system is manufactured by Dow Corning. The author discusses Norplant's mechanism of action, pharmacokinetics, effectiveness, legal challenges, side effects, other specific concerns with Norplant, continuation rates, insertion, removal, removal techniques, patient selection and counseling, and the future, and notes that the device still faces challenges four years after its introduction.
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Deeply inserted, nonpalpable contraceptive implants can often be removed easily using 6-8 cm3 of 1% lidocaine and a single 1 cm incision. There is no need for suturing of the incision. The location of nonpalpable implants not retrieved by this procedure can be determined by a plain, soft tissue x-ray (standard AP and lateral and internal oblique; 45-55 kVP) of the area where the implants are inserted. Removal can then be accomplished several weeks later. PIP Between October 1992 and January 1995 clinicians removed 48 deeply inserted, nonpalpable contraceptive implants at Grady Health System in Atlanta, Georgia. They used 6-8 cu. cm of 1% lidocaine and a single 1-cm incision. No suturing of the incision was needed. The incision scars were small and the women found the scars cosmetically acceptable. 90% of the removals were conducted in no more than 30 minutes. No complications occurred. One clinician used soft tissue X-ray, plain X-ray, fluoroscopy, and ultrasound to locate the nonpalpable implants in one volunteer to determine the most cost-effective method of locating them. Neither fluoroscopy nor plain X-ray located the implants. The soft tissue X-ray, low KVP X-ray, and ultrasound detected the implants. These findings indicate that the technique used to identify and remove nonpalpable contraceptive implants at Grady Health System in Atlanta is simple and cost-effective and also benefits patients and clinicians.