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This case report from united states was derived from medical literature on 07-may-2014, article entitled "management of complications encountered with essure hysteroscopic sterilization: a systematic review." it refers to a female patient of unspecified age who had fallopian tube occlusion insert inserted for hysteroscopic sterilization and experienced malpositioned device in peritoneal cavity.The tradename was reported to be essure.Case report: one patient experienced 3 years of pain and underwent a laparoscopy before the micro-insert was eventually identified on ct scan, and underwent subsequent removal via laparoscopy with intraoperative fluoroscopy.The patient experienced resolution of pa2n postoperatively.Abstract: essure hysteroscopic sterilization has been fda approved in the united states since 2002.Complications associated with essure include improper placement (malpositioning), unintended pregnancy, pain, infection, and nickel allergy.The rarity of complications, compounded by underreporting, makes it difficult to determine best practices with regards to management.This systematic review synthesizes the national and global experience with management of essure-related complications, and suggests treatment options where data allow.Authors comment: there were 2 patients who experienced prolonged periods of pain, with lengthy evaluations, both of which ultimately required removal of the devices from the peritoneal cavity.One patient experienced 3 years of pain and underwent a laparoscopy before the micro-insert was eventually identified on ct scan, and underwent subsequent removal via laparoscopy with intraoperative fluoroscopy.All patients with pain and malpositioned devices experienced resolution of their pain postoperatively.Related case:(b)(4).Follow up received on (b)(4)2014.This case report is from a literature article titled "complication of the essure implant sterilization procedure: a case report" authored by pyke r, blackwood lr.Case report: a (b)(6) presented with a 3-year history of left lower quadrant pain.The pain was intermittent, occurring in the mid-portion of the left side of the abdomen and left lower quadrant.The pain was relieved by lying down and exacerbated by standing up.The pain was not worse during intercourse or vigorous exercise.The episodes became progressively worse over the course of 1.5 years.She denied nausea and vomiting, and eating had no effect on the pain.She denied diarrhea or constipation, and the pain was not related to bowel movements.She lost 15 pounds over several months, and the pain woke her up at night.The patient had essure implants for permanent sterilization placed in (b)(6) 2004.The marker on the essure implant placed in the right tube was difficult to visualize.According to the surgeon, the blackened marker was unable to be visualized and there were no trailing coils within the uterine cavity.The procedure was continued on the left side and three trailing coils were identified in the uterine cavity.The implant sheath was compared and thought to be identical.The surgeon determined the right micro-insert had been deployed correctly but higher in the tubal canal.As per procedure, a hysterosalpingogram revealed the occlusion of the right fallopian tube but free spillage of the dye in the left fallopian tube.The left essure implant was at the level of the iliac crest outside the tubal ostia with the patency of the left tubal segment.The patient was counseled that the displacement of the implant was probably due to tubal cramping.Following this procedure, the patient began experiencing the above symptoms.Informed consent was obtained for an exploratory laparoscopy and bilateral tubal coagulation.Although the patient preferred to have a repeat placement of the essure implant on the left, her insurance company would not approve it.She was counseled of the risks, benefits, and alternatives to inspect the pelvis and abdomen to find the essure implant, knowing the likelihood was they would not find jt.A laparoscopy was performed to complete the sterilization process.Exploration of the abdomen was performed, which failed to locate the implant.The distal portion of the right essure implant was identified.The upper abdomen, liver edges, gallbladder, and splenic areas were inspected, but there was no evidence of the implant.Both fallopian tubes were coagulated by using the kleppinger forceps.The left tube was coagulated in the mid ampullary portion of the left tube in three sequential areas.The procedure was repeated on the right side, but inferior to the area of the implant, so as not to coagulate the implant itself.The pelvis was again inspected, and there was no evidence of the displaced implant.She continued to have pain and began having a work-up of other organ systems.She had a urinalysis for hematuria and was treated with antibiotics.A work-up for kidney infection was performed and was negative.Mri was performed to evaluate the spine, and there was no evidence of nerve-root impingement.The thoracic spine was essentially normal as well.An intravenous pyelogram evaluation was negative and ruled out evidence of dilatation or obstruction of the ureter.A summary plan description scan of the abdomen was consistent with adenopathy and negative for a foreign body.A computed tomography (ct) scan of the pelvis revealed a metallic structure in the left aspect of the pelvis and adjacent to the anterior portion of the colon.In 2007, the patient was evaluated by a second obstetrician or gynecologist.An ultrasound of the abdomen showed normal liver, gallbladder, and kidneys.A pelvic ultrasound was consistent with a normal-size uterus and normal-appearing ovaries.She had a first-degree uterine prolapse and a pessary was inserted, but there was no improvement in her symptoms.She was referred to a gastroenterologist and a colonoscopy was scheduled.They were not convinced the pain was associated with the bowels, but suggested the colonoscopy, because of a family history of polyps.However, she developed a severe episode of left lower quadrant pain associated with vomiting and was evaluated in the emergency room.Her white blood count was 5700.One (1) month prior to admission, her hematocrit was 42.2 and hemoglobin was 14.8.(b)(6) cultures were (b)(6).Ct scan was performed.She was placed in the supine position for the first study and then prone in the second study.The essure implant was not visualized in the supine position but was seen in the prone position on the left lateral side of the lower pelvis adjacent to the descending colon.There was no evidence of free air or free fluid in the pelvis.This suggested that the essure implant was freely mobile within the peritoneal cavity.An exploratory laparoscopy procedure was performed with fluoroscopy after the insertion of a 10-mm port through an umbilical incision and two 5-mm ports were placed in each lower quadrant of the abdomen.Fluoroscopy was used to visualize the entire abdomen,and the essure implant was located adjacent to the left lobe of the liver.A long probe was used to identify the implant with the aid of the fluoroscopy.It was determined to be located in a portion of omentum, which was in the left upper quadrant on the abdomen under the liver.The omentum was grasped and moved to a more accessible region of the pelvis.Although the implant could not be visualized in the omentum by laparoscopy yet, the fluoroscopy confirmed the implant moved with the inferior portion of the omentum.The coil was finally identified by using fluoroscopy and laparoscopic graspers.The implant was removed with a portion of the omentum and sent to pathology.The colon was free of diverticula or evidence of inflammation.The pelvis was inspected and found to be consistent with a defect in both fallopian tubes from the coagulation.The uterus had a smooth surface, with no evidence of endometriosis of adhesions.Both ovaries were normal in size and appearance.Pathology was consistent with the gross implant, which was intact with attached fragments of benign fibro-fatty connective tissue.Postoperatively, the patient did very well.She no longer complained of the pain.Author's comment: this is a case report illustrating a patient who had the insertion of the essure implant with a perforation into the peritoneal cavity (previously mentioned as malpositioned device in peritoneal cavity) and entrapment into the omentum, causing chronic pain.It illustrates how this small implant can cause morbidity, and the use of fluoroscopy can aid in locating the tiny micro-insert if it is dislodged into the abdominal cavity.Other cases from this article: (b)(4).Follow-up information received on (b)(6) 2014: ptc number provided (b)(4).Follow-up received on (b)(4) 2014: product technical complaint investigation and final assessment were received: this adverse event report is related to a product technical complaint (ptc)- incident report.The bayer reference number for the ptc report is: (b)(4).Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect at this time.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.Additionally, the case reported dislocation of device and complication of insertion due to a medical event.These events are also not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without a batch number.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect".Based on the information available, there is no reason to suspect a quality defect.
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