- Author: Gamal Mostafa Ghoniem, MD, FACS; Chief Editor: Kris Strohbehn, MD more...
Pelvic organ prolapse (POP), including cystocele, is a major health concern, especially in the elderly. In the United States, more than 200,000 operations are performed annually for POP ; reoperation rates reach 30%. Anterior vaginal wall prolapse (AWP) is the most common form of female POP, with 81% of prolapse repairs including the anterior vaginal wall. Furthermore, AWP carries the highest risk for recurrence, with reported recurrence rates as high as 41%. In this article, we use the term "cystocele" to represent AWP.
The vaginal wall is normally supported by strong fascial and ligamentous attachments. Delancey divided vaginal support into the following 3 levels:
Level 1 - The cardinal-uterosacral ligament complex, which functions as suspensory "leashes," holding the cervix and upper vagina
Level 2 - The lateral connections of the vagina to the arcus tendineus fasciae pelvis (ATFP), or "white line," which support the middle portion of the vagina
Level 3 - Fascial connections to the perineal membrane anteriorly and the perineal body posteriorly, which support the lower vagina
Disruption of 1 or more of these support structures might precipitate POP, including cystocele. Depending on the site of fascial detachment, cystocele can be central (midline defect of the pericervical fascia; about 1% of cases), lateral (detachment of the pericervical fascia from the ATFP; about 80-85% of cases), or apical (detachment from the uterosacral ligaments or the pericervical ring; about 15% of cases). A combination of lateral and central defects is also common. Surgical repair should address these defects accordingly.
The risk factors for developing POP include age, parity, obesity, chronic constipation, hormonal status, previous gynecologic surgery and hysterectomy, chronic obstructive airway disease, smoking, high-impact activity, and genetics.
A patient with cystocele may be asymptomatic, especially in the early stages. Symptomatic patients may experience fullness or pressure in the pelvis or vagina, a "ball" or "lump" protruding from the vagina, lower back pain or pressure, problems with bladder emptying or bowel movements, dyspareunia, or vaginal bleeding.
Urinary symptoms associated with cystocele include urinary frequency and urgency (35%), urge urinary incontinence (15%), stress urinary incontinence (60%), and difficulty voiding (23%). Urodynamically diagnosed bladder outlet obstruction was found more frequently with higher-stage cystoceles than with lower-stage cystoceles.
In patients with advanced POP, diagnosis of occult stress urinary incontinence is critical. This can be accomplished by means of urodynamic studies, with and without prolapse reduction. The positive cough (Valsalva) stress test after prolapse reduction during urodynamic studies indicates that an anti-incontinence procedure at the time of prolapse repair is necessary.[5, 6] Several authors have questioned whether urodynamic evaluation is predictive with regards to outcomes compared to less invasive office evaluations such as cough stress testing.
Guidelines for the management of POP have been developed by the American College of Obstetricians and Gynecologists.
Prolapse repair is indicated for relief of patient symptoms, restoration of the normal anatomy and function of the pelvic structures, prevention of prolapse recurrence, and repair of concomitant intrapelvic defects. It should be offered to all patients who are symptomatic, are good surgical candidates, and are willing to pursue surgical treatment. A cystocele associated with bladder outlet obstruction is also an indication for surgical correction.
Cystocele repair is contraindicated in the following patients:
Patients with local vaginal diseases, including vaginitis and neoplasms
Patients who are not surgically fit
Patients who are not willing to undergo surgery
Patients who have early-stage asymptomatic cystoceles
Key technical considerations include the choice of surgical approach and the adoption of measures to reduce complications.
Many surgical procedures have been described for cystocele repair. The surgical approach can be either vaginal or abdominal. The 3 basic techniques for cystocele repair are anterior colporrhaphy, anterior colporrhaphy with graft, and paravaginal repair, of which the first 2 are the most commonly used (see the image below). If apical involvement is noted, cystoceles may often be resolved after resuspension of the apical defect.
The grafts used for cystocele repair are subclassified according to their materials. These materials include autologous tissue (rectus fascia , fascia lata, vaginal wall), allografts (fascia lata, dermis, dura mater), xenografts (porcine small intestine submucosa, porcine dermis, bovine pericardium), and synthetic grafts (absorbable and nonabsorbable). Varying success rates have been reported for all of these. Biomaterials seem to work by providing a scaffold for host tissue growth.
The balance between tissue regrowth and graft dissolution plays a major role in the success of surgical cystocele repair. Synthetic grafts are permanent and, if properly positioned and secured, yield better long-term success rates; however, they are associated with higher risks of infection, extrusion (into the vagina), and erosion (into the bladder and or urethra). When polypropylene mesh is used for cystocele repair, extrusion rates as high as 25% have been reported.
Graft anchoring techniques also vary. Free grafts are anchored to the vaginal sulcus with absorbable or permanent sutures. The transobturator approach entails the use of suspension arms passed through the obturator foramen, which suspend the graft through the ATFP. Some other grafts are suspended to the sacrospinous ligaments, which provide apical support as well.
Several ready-made kits now on the market make use of the arm suspension concept for graft support. Examples include Perigee and Elevate anterior (American Medical System), Uphold LITE (Boston Scientific), and Prolift Anterior (Ethicon).
On July 13, 2011, the FDA issued a statement that serious complications are not rare with the use of surgical mesh in transvaginal repair of pelvic organ prolapse. The FDA reviewed the literature from 1996-2011 to evaluate safety and effectiveness and found surgical mesh in the transvaginal repair of pelvic organ prolapse does not improve symptoms or quality of life more than nonmesh repair. The review found that the most common complication was erosion of the mesh through the vagina, which can take multiple surgeries to repair and can be debilitating in some women. Mesh contraction was also reported, which causes vaginal shortening, tightening, and pain.
The FDA’s update states, "Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion." The FDA is continuing to review the literature regarding surgical mesh in the treatment of stress urinary incontinence and will issue a report at a later date. See the full update regarding surgical mesh in pelvic organ prolapse here: FDA Safety Communication: Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Graft-associated infection is a major concern. Preoperative antibiotic prophylaxis with an antibacterial that covers gram-positive and gram-negative strains is appropriate. Cefotetan is a good choice; gentamicin plus vancomycin combination is an alternative in patients who have penicillin allergies. The authors use a mixture of neomycin sulfate (2 mL in 500 mL of 0.9% NaCl). The graft is also soaked in the same solution before insertion. Cefotetan is a reasonable alternative if the patient is allergic to sulfa.
In addition to the standard vaginal preparation and draping, the use of an antimicrobial drape (eg, Ioban; 3M) helps isolate the surgical field from the anus and other nearby potential sources of contamination. Intraoperative wound irrigation washes out free clots and tissue debris.
One of the predisposing factors for infection is the development of a hematoma. The authors ensure intraoperative hemostasis by using both hemostatic sutures and an electrocautery. During vaginal skin closure, the authors intentionally close the proximal part of the incision in a continuous fashion to facilitate hemostasis and close the distal part in an interrupted fashion to allow drainage of any potential bleeding and thus avoid hematoma formation.
Preoperative estrogen therapy has been found to help with intraoperative dissection, promote postoperative healing, and decrease the risk of graft extrusion. The dose of estrogen required for treatment of vaginal atrophy is less than that which would be expected to cause endometrial hyperplasia.
Previous vaginal surgical procedures add to the technical difficulty and increase the risk of bleeding. To minimize this complication, the patient should be evaluated for bleeding risk. All anticoagulant medications should be stopped for 7-10 days before surgery if possible. We routinely check the patient's coagulation profile before surgery.
To minimize the risk of nerve injury, the patient should be properly positioned in well-padded stirrups, all pressure points should be padded, overlay stretch should be avoided, and retractor blades should be placed under direct vision. Awareness of the neuroanatomy of the female pelvis is critical for recognizing and avoiding the common sites of nerve entrapment.
As noted (see above), POP is associated with advanced age. The aging population is also at higher risk for deep venous thrombosis (DVT), and the risk increases further with prolonged pelvic surgical procedures in the dorsal lithotomy position. Preoperative anticoagulation with heparin, pneumatic antiembolism stockings, and early postoperative ambulation are the keys to minimizing this critical complication.
The 3 basic techniques for cystocele repair are anterior colporrhaphy, anterior colporrhaphy with graft, and paravaginal repair (see below).
In patients with advanced prolapse (stage III and beyond), restoration of anatomy and function usually necessitates more than 1 repair: concomitant posterior, apical, and enterocele repairs are usually required. Our order of repairs starts with the apical sutures, which are tagged and left untied until the anterior repair is complete. The sutures are then tied, a sling procedure for incontinence is performed if needed, and the posterior repair and levatorplasty are left to the end.
If apical support is indicated, sacrospinous ligament suspension is the authors' preferred procedure. As mentioned (see below), this procedure carries the risk of bleeding and nerve injury. Awareness of the anatomy is critical to minimize these complications. Passing the needle into the ligament is safer from above (proximal to distal). The authors routinely use the Capio device for this purpose.
When performing any of these techniques, care should be taken not to excise excess vaginal skin and thereby potentially compromise the required tension-free closure. Furthermore, excessive excision of the vaginal skin might result in vaginal stenosis.
The authors have found that combining anterior colporrhaphy with a graft yields better results than either alone; accordingly, the authors routinely plicate the endopelvic fascia before inserting the graft.
The basis of anterior colporrhaphy is plication of the pubocervical fascia with the aims of repairing the midline fascial defects and tightening up the stretched-out fascia.
With the patient in the lithotomy position, a 16 French Foley catheter is inserted into the bladder. Appropriate exposure of the vaginal skin is obtained by using a weighted vaginal speculum and labial retractors. The incision is made from a point just proximal to the bladder neck and extended proximally up to a point 2 cm from the vaginal apex.
The incised anterior vaginal wall is then held with 2 Allis clamps, and hydrodissection is performed by injecting the dissecting solution submucosally. Our hydrodissection solution is a mixture of local anesthetic (bupivacaine or lidocaine) and a local hemostatic solution (epinephrine). This mixture ensures local pain relief after surgery, hemostasis, and hydrodissection.
After hydrodissection, the anterior vaginal wall is incised longitudinally with a No. 15 blade. The vaginal epithelium is then separated from the pubocervical fascia by means of Metzenbaum scissors and blunt dissection with a 4 × 4 piece of wet gauze (see the image below).
Dissection should be continued laterally to the vaginal sulci and proximally to the vaginal cuff (if the patient has had a hysterectomy) or the cervix. During this process, hemostasis should be obtained by using both the electrocautery and hemostatic sutures (see the image below). Fascial plication is then carried out with delayed absorbable sutures (2-0 polyglactin). The fascia is approximated from side to side with interrupted sutures.
Care should be taken not to overplicate the fascia; doing so increases the risk of ureteral kinking and obstruction. Usually, 1 layer of plication is sufficient, though more than 1 layer may be required in patients with advanced (stage III and IV) cystoceles. To minimize the risk of recurrence, the detached fascia should be reattached to the supported vaginal apex. If apical prolapse is associated with the cystocele, the plicated fascia should be attached to the apical suspension sutures.
At the end of the plication process and before vaginal skin closure, cystourethroscopy should be performed after intravenous (IV) injection of indigotindisulfonate and furosemide. During cystourethroscopy, attention should be paid to the ureteral orifices; free efflux of blue solution from both ureteral orifices should be visible.
Anterior colporrhaphy with graft
A biologic or synthetic graft (see the images below) may be used to provide extra support to the weakened tissues. It can be sutured to the cardinal-uterosacral ligament complex proximally, the endopelvic fascia distally, and the obturator fascia laterally.
The initial part of the technique is similar to that of standard anterior colporrhaphy (see above). The graft is then trimmed to a trapezoid shape, with the size tailored to the dimensions of the anterior vaginal wall. Proximally, 2 sutures (2-0) polyglactin) are taken through the cardinal ligaments. Distally, another 2 sutures are taken through the pericervical fascia close to the pubic bones, 1 on each side. The graft is secured to these sutures, and lateral sutures (3-0 polyglactin) are used to secure the graft to the obturator fascia.
Ready-to-go kits have been developed to speed up the repair process and reduce the need for extensive dissection and suturing. These kits usually include the graft body (which is designed with specific dimensions), the graft arms and legs, and the passers needed for guiding the graft arms through the supporting structures (see the image below). With the Gynemesh, Prolift Anterior, and Perigee, the graft is secured via the transobturator approach. The Elevate anterior and Uphold LITE are inserted using a single incision. The Elevate anterior has 4 arms with 2 distal arms secured into the obturator membrane and fascia, and the posterior arms are inserted into the sacrospinous ligaments. The Uphold LITE has only 2 anchors that are inserted into the sacrospinous ligaments.
After anterior vaginal wall dissection is completed, the skin is marked to indicate the puncture sites for the graft passers. The 2 anterior sites, 1 on each side, are marked at a point 1 cm below the insertion of the adductor longus muscle and approximately at the level of the clitoris. If a transobturator sling is being placed, the anterior skin punctures for the graft passers are made slightly posterior to those for the sling. The posterior puncture sites are placed 3 cm posterior and 2 cm lateral to the anterior ones.
After infiltration of local analgesics, the skin is punctured at these marked sites with a No. 15 blade. The anterior passers are passed first, guided by the index finger of the other hand in the vaginal incision. The posterior passers are then passed, again guided by the index finger close to the ischial spines. Cystoscopy is performed to rule out bladder or urethral injuries and to confirm ureteral patency.
With the Perigee kit, the 4 different passers are passed next, and cystoscopy is performed before the graft arms are connected to the passers. With the Avaulta and Gynemesh kits, the graft arms can be passed first because 1 reusable needle is used. After the graft arms are passed, tension is adjusted, the graft arms are cut flush with the skin, and the skin punctures are glued. The vaginal skin is trimmed as needed, the wound is copiously irrigated, and the vaginal incision is closed.
Paravaginal approach may be carried out via either an abdominal or a vaginal approach.
Abdominal paravaginal cystocele repair was redescribed by Richardson in 1976. after initial description by White in 1909. It is performed with the patient in the dorsal lithotomy position. A 16 French Foley catheter is inserted into the bladder. The bladder should be well drained.
A midline or Pfannenstiel suprapubic abdominal incision is made. The incision is continued through the layers of the anterior abdominal wall. The bladder is freed from the pelvic sidewalls by means of blunt and sharp dissection. The space of Retzius is exposed. Care should be taken to avoid the retropubic venous plexus. At the end of the dissection, the posterior border of the symphysis pubis, Cooper’s ligaments, the white lines, and the bladder neck should be visualized.
The needle, with a nonabsorbable suture, is passed through the full thickness of the vaginal epithelium (avoiding the mucosa). A finger is placed in the vagina to guide suture placement. The suture is then passed through the obturator internus fascia, including the white line. Finally, the needle is passed through the pericervical fascia.
Sutures are placed in an interrupted fashion, proceeding from proximal to distal. Before they are tied, cystourethroscopy is performed to rule out suture passage through the bladder and to confirm ureteral patency. After cystourethroscopy, the sutures are tied and cut.
This procedure is performed on both sides. If hysterectomy is to be performed, the peritoneum is closed before the paravaginal repair. Laparoscopic paravaginal repair can also be performed in a similar fashion.
Vaginal paravaginal repair is aimed at repairing the lateral vaginal wall defects. This can be accomplished by using the grafts as described above, with the lateral edges of the grafts being secured to the obturator fascia by means of 3-0 polyglactin sutures.
Complications of Cystocele Repair
Complications may occur either during or after repair of a cystocele.
Most surgeons define excessive vaginal bleeding as that which necessitates blood transfusion. The reported blood transfusion rate for prolapse surgeries (including cystocele repair) was 3 out of 519 patients. Bleeding is more common in patients undergoing concomitant vaginal reconstructive procedures, especially sacrospinous ligament fixation. Likewise, concomitant hysterectomy increases the chance of excessive bleeding. Increased body mass index is another risk factor that increases bleeding during vaginal hysterectomy.
If bleeding occurs, good exposure with appropriate retractors and the use of headlights will facilitate location of the bleeding structures and further management. Packing, electrocauterization, suture ligation, and embolization by interventional radiology are treatment options. Lost blood should be replaced. The complete blood count and vital signs should be checked regularly after surgery until stability is assured.
Injury to bladder, ureter, or urethra
The reported incidence of injury to the bladder, ureters, or urethra was between 4% and 11%, with bladder injury being the most common of these.[15, 16] Other forms of urinary tract injuries related to vaginal reconstructive surgery include ureteral obstruction (when the ureters are tied or kinked), urethral traumas, and suture transfixation to the bladder. Kwon et al reported a 2% incidence of ureteral obstruction after anterior colporrhaphy.
Intraoperative cystoscopy is performed during most vaginal surgical procedures to diagnose and treat possible urinary tract injuries and prevent long-term consequences. The 70º lens is used with a full bladder and after the injection of 1 ampule of indigotindisulfonate and furosemide 10 mg IV. Attention is directed to the anterolateral bladder walls, the ureteral orifices, and the urethra. Moving the trocars while they are in place can reveal their exact sites and confirm that bladder perforation has not occurred.
Intraoperative cystotomy should be repaired primarily, and bladder drainage should be maintained for 5-7 days. Cystotomy caused by the passed trocars is managed by removal of the trocars and repositioning after complete emptying of the bladder. The trocars should “hug” the bone as they are passed. Ureteral obstruction, as diagnosed by failure to see free fluid efflux, can be managed by revising the sutures. Urethral trauma is managed by urethrorrhaphy, avoidance of synthetic slings, and long catheter drainage of at least 1 week's duration.
Nerve can occur after improper positioning, improper use of abdominal retractors, or direct nerve trauma. Pain at the buttock and back of the thigh that radiates downward, with or without foot drop, suggests sciatic nerve injury. This complication usually occurs after prolonged use of free-hanging stirrups. It could also occur during sacrospinous ligament fixation procedures. Taking the sutures out usually solves the problem.
Inability to flex the hip or extend the knee is usually a presenting symptom of femoral nerve injury. This is usually associated with pain or paresthesia at the anteromedial aspect of the thigh and leg. Femoral nerve injury may occur as a result of long compression by abdominal retractor blades; it may also occur with prolonged overabduction of the hips. Other common nerve injuries after female pelvic procedures include peroneal, iliohypogastric, ilioinguinal, obturator, and pudendal nerve injuries.
To avoid these complications, the patient should be properly positioned using well-padded stirrups, all pressure points should be padded, overlay stretch should be avoided, and retractor blades should be placed under direct vision. Furthermore, awareness of the neuroanatomy of the female pelvis is critical to recognize and avoid the common sites for nerve entrapment.
This is generally rare during vaginal prolapse repair. The rectum is most commonly injured during rectocele repair. Small bowel injury can also occur during enterocele repair or sacrospinous ligament fixation procedures. Small rectal tears can be closed primarily, especially if the patient was bowel prepped before surgery.
Anesthesia-related complications are possible, as in any other surgical procedure. One of the major complications that accompanies cystocele repair is deep venous thrombosis (DVT), with the subsequent risk of pulmonary embolism (PE).
Vaginal surgery is a clean-contaminated procedure and carries a risk of postoperative infection. Infections may involve the wound or graft or may be systemic. Prolonged procedures, excessive intraoperative bleeding, advanced patient age, and reduced overall immunity increase the risk of infection after surgery. Preoperative antibiotic prophylaxis and appropriate intraoperative field preparation decrease the potential for this complication.
Mesh erosion refers to the extrusion of mesh into any part of the urinary tract or vagina. Mesh extrusion is initially managed by the application of local estrogen. Drake et al reported a 10.9% mesh extrusion rate after dermal allograft use; 13 weeks of local estrogen therapy was 100% successful in treating the extrusion. If local estrogen fails, partial or complete mesh excision may be required. Dyspareunia, pelvic or vaginal pain, vaginal narrowing, vaginal bleeding, and discharge are other possible mesh-related complications.
As noted above in the Procedural Planning section, on July 13, 2011, the FDA issued a statement that serious complications are not rare with the use of surgical mesh in transvaginal repair of pelvic organ prolapse. The FDA reviewed the literature from 1996-2011 to evaluate safety and effectiveness and found surgical mesh in the transvaginal repair of pelvic organ prolapse does not improve symptoms or quality of life more than nonmesh repair. The review found that the most common complication was erosion of the mesh through the vagina, which can take multiple surgeries to repair and can be debilitating in some women. Mesh contraction was also reported, which causes vaginal shortening, tightening, and pain.
See the full update regarding surgical mesh in pelvic organ prolapse here: FDA Safety Communication: Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.
De novo voiding symptoms
Voiding symptoms occur de novo in 10% of women who undergo anterior colporrhaphy. This might be related to dissection and nerve injury, plication resulting in bladder outlet obstruction, or both.
One study reported an 18% rate of dyspareunia resulting in deteriorated sexual function after anterior colporrhaphy concomitant with posterior colpoperineorrhaphy. A study from Taiwan suggested that transvaginal mesh repair, though effective and safe for severe cystocele, may have effects on sexual activity, as well as voiding. A prospective study from Germany found that surgical repair of symptomatic pelvic organ prolapse using mesh implants results in improvement of major parameters of sexual function.
Patient education/informed consent
Patients should be actively involved in the decision-making process with respect to cystocele repair. They should be counseled regarding expected surgical outcomes, potential mesh-related complications, and the possibility of recurrence after successful repair.
The equipment required for vaginal cystocele repair includes the following:
Vaginal preparation - Chloroxylenol (PCMX) at 3% (Techni-care)
Drapes - Lingeman and Ioban drapes
16 French Foley catheter
Basic laparotomy set (for abdominal repair) or basic vaginal surgical set (for vaginal repair)
Retractors - A weighted vaginal speculum and labial retractor (eg, Lone Star); Breisky-Navratil retractors help during vaginal suspension procedures; malleable retractors can also be helpful
Needle holders - A standard bulldog needle holder is frequently used; a Haney needle holder is the type most commonly used in vaginal surgery
Forceps - A DeBakey forceps is frequently used in vaginal procedures
Scissors - Standard Metzenbaum scissors; tenotomy scissors have finer points and sharper tips for more precise cutting; heavy-duty Mayo and Jorgensen scissors are used to cut sutures, excessive meshes, and slings, as well as for mass tissue cutting
Local infiltration solution - 1% lidocaine with epinephrine and 0.5% bupivacaine in a 50:50 mixture
Irrigation solution - 2 mL of neomycin sulfate and polymyxin P dissolved in 500 mL of normal saline
Other necessary intraoperative medications - Intravenous (IV) indigotindisulfonate (Indigo Carmine), furosemide 10 mg IV, topical skin adhesive (eg, Dermabond; Ethicon), and either estrogen cream or metronidazole gel (MetroGel)
Sutures and needles - 3-0 polyglactin (Vicryl) on a small half CR-8 needle and 3-0 polyglactin on a UR-6 needle
Dressing - Vaginal packing, usually soaked in estrogen cream or metronidazole gel
Appropriate choice of anesthesia and patient position is important for optimal results.
The choice of anesthesia mainly depends on the patient's condition and the surgeon’s preference. Regional and general anesthesia are commonly used for vaginal prolapse repair. Local anesthesia with sedation has also been described. Local anesthesia is an attractive option for cystocele repair and is associated with lower complication rates.
In a population-based, retrospective study that compared local anesthesia with general and regional anesthesia in 1364 patients who underwent cystocele repair, local anesthesia was found to be associated with a reduced hospital stay, a shorter duration of use of postoperative analgesic drugs, and a quicker return to regular activity. Postoperative complications did not differ among groups. Patient satisfaction was not related to the method of anesthesia employed.
The dorsal lithotomy position is preferred for vaginal surgery. The patient is placed first in the supine position, with the buttocks slightly beyond the end of the operating table to ensure that the weighted vaginal speculum is secured and will not slip out during the procedure. The hips and knees are flexed, with each knee and leg aligned with the patient’s opposite shoulder. The feet are strapped in position in padded stirrups. All pressure points should be well padded with soft pillows or alternative materials.
Monitoring and Follow-up
Vaginal packing soaked with estrogen cream is inserted and left in place for 24 hours. The Foley catheter is removed the next morning, and a trial of voiding is performed before the patient is discharged home. A regular diet can be resumed as tolerated.
Postoperative instruction should include a specific recommendation to avoid sexual intercourse for 6 weeks. The patient should also refrain from lifting heavy (>10 lb) objects for at least 3 months. Follow-up visits are scheduled according to the surgeon's preference. The authors perform the first vaginal examination 6-8 weeks after the operation and subsequent examinations at 2 months, 6 months, 12 months, and every 12 months thereafter.
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