OBJECTIVEProvide the suggestion for MDAEs monitoring and the reference to strengthen the medical device administration by analyzing the 1900 reports of MDAEs.

METHODWith retrospective case study, analyze 1900 MDAE reports in Henan province in 2008. RESULT Orthopedic implants and the intrauterine device (IUD) caused the higher proportion of adverse events with serious degree. The scope that the reports covered needs to be raised.

CONCLUSIONFurther focus monitoring on orthopedic implants and the IUD should be strengthened. The medical device adverse events monitoring should be promoted by improving regulations, training and publicity.

The activity of matrix metalloproteinases (MMPs) in the uterine flushing and endometrial tissue of normal adult women wearing FCu-IUD (fixed Cu-IUD) or FICu-IUD (indomethacin-releasing FCu-IUD) was observed by using zymography on SDS-PAGE containing gelatin. The results showed that the activity and kinds of MMPs in FCu-IUD group were increased significantly as compared with themselves before being inserted FCu-IUD. However, compared with the FCu-IUD group, the activity of some kinds of MMPs in the FICu-IUD group was decreased significantly. These data suggest that IUD can enhance the activity of MMPs in human endometrium, intermediated by prostaglandins, and MMPs may have relation to IUD-induced menorrhagia and indomethacin reduces IUD-induced menorrhagia by partly inhibiting MMPs synthesis.
Adult ; Endometrium ; enzymology ; Female ; Humans ; Indomethacin ; Intrauterine Devices, Copper ; adverse effects ; Intrauterine Devices, Medicated ; adverse effects ; Matrix Metalloproteinases ; metabolism ; Middle Aged ; Uterine Hemorrhage ; etiology ; prevention & control

The activity of matrix metalloproteinases (MMPs) in the uterine flushing and endometrial tissue of normal adult women wearing FCu-IUD (fixed Cu-IUD) or FICu-IUD (indomethacin-releasing FCu-IUD) was observed by using zymography on SDS-PAGE containing gelatin. The results showed that the activity and kinds of MMPs in FCu-IUD group were increased significantly as compared with themselves before being inserted FCu-IUD. However, compared with the FCu-IUD group, the activity of some kinds of MMPs in the FICu-IUD group was decreased significantly. These data suggest that IUD can enhance the activity of MMPs in human endometrium, intermediated by prostaglandins, and MMPs may have relation to IUD-induced menorrhagia and indomethacin reduces IUD-induced menorrhagia by partly inhibiting MMPs synthesis.
Endometrium/*enzymology ; Indomethacin ; Intrauterine Devices, Copper/*adverse effects ; Intrauterine Devices, Medicated/*adverse effects ; Matrix Metalloproteinases/*metabolism ; Uterine Hemorrhage/etiology ; Uterine Hemorrhage/prevention & control

OBJECTIVETo provide suggestion for MDAEs monitoring with analyzing the features of the 1028 reports of MDAEs.

METHODSWith retrospective case study, this paper analyzed 1 028 MDAE reports in Guiyang during 2012.

RESULTSThe intrauterine device (IUD) caused the higher proportion of adverse events with serious degree. Monitoring consciousness of grassroots users needs to be improved. The quality of the reports should be enhanced.

CONCLUSIONSMore attention should be paid to monitoring on IUD. The level of MDAEs monitoring should be improved through carrying out targeted training and publicity, establishing and improving MDAEs monitoring network.

Intrauterine device(IUD)migrating to the bladder is rare,especially the migration far away from the uterus into the bladder wall.Due to no obvious clinical symptom in the early stage and being far away from the uterus,the IUD totally embedded in the bladder wall is prone to misdiagnosis and delay in treatment.We reported one case of such migration,aiming to improve the clinical management of the IUD totally embedded in the bladder wall.
Female ; Humans ; Urinary Bladder/surgery* ; Uterus ; Pelvis ; Intrauterine Devices/adverse effects*

OBJECTIVE: To evaluate the efficacy and adverse effects of levonorgestrel-releasing intrauterine system (Mirena) in the treatment of adenomyosis. METHODS: The clinical data of 75 patients with adenomyosis who had Mirena insertion in Women's Hospital,Zhejiang University School of Medicine from September 2013 to December 2013 were retrospectively analyzed. The patients were followed up to 39 months. The efficacy and adverse effects were assessed. RESULTS: Pictorial Blood Loss Assessment Chart (PBAC) scores were decreased significantly after Mirena insertion both in patients with menorrhea (118±13 vs. 29±33, <0.01) and normal menstruation (82±15 vs. 14±13, <0.01); the patients with menorrhea showed a more significant decrease in PBAC score than those with normal menstruation (90±35 vs. 69±19,<0.01). The visual analogue scale (VAS) score decreased significantly after Mirena insertion compared with pre-treatment[7(6,7) vs. 1(0,2), <0.01]. The expulsion of Mirena occurred in 18 cases (24.0%); 9 cases (12.0%) had no effect and 28 cases (37.3%) had changes of menstruation patterns. Multivariate Cox regression analysis showed that the expulsion of Mirena was not associated with post-treatment VAS score, PBAC score before and after treatment or menstrual stabilization time (all >0.05). CONCLUSIONS Mirena is effective and safe in the long term management of adenomyosis, but about one third patients may require further treatment because of the expulsion or ineffectiveness of Mirena.
Adenomyosis ; Female ; Humans ; Intrauterine Devices, Medicated ; adverse effects ; standards ; Levonorgestrel ; administration & dosage ; adverse effects ; standards ; Retrospective Studies

Intrauterine contraceptive device (IUCD) is relatively safe but still with some serious risks. Uterus perforation is rare and would be fatal. A case of Cu-7 IUCD invading into the sigmoid colon through uterine perforation caused by a pelvic blunt trauma was presented. Our case showed that uterus perforation by an IUCD could induce utero-sigmoid fistula which is likely to be missed. Imaging is required when the patients with IUCD present abdominal pain, particularly with a history of trauma.
Adult ; Colon, Sigmoid ; injuries ; Female ; Foreign-Body Migration ; complications ; Humans ; Intrauterine Devices ; adverse effects ; Uterine Perforation ; etiology ; Wounds, Nonpenetrating ; etiology

Abortion, Induced ; adverse effects ; Adult ; Device Removal ; Embolization, Therapeutic ; Female ; Humans ; Intrauterine Devices ; Pregnancy ; Uterine Artery ; Uterine Rupture ; etiology

OBJECTIVE: An ex vivo study found a copper-containing intrauterine device (IUD) to be safe for women undergoing an MRI examination at a 3.0-T field. No significant artifacts caused by the metallic implant were detected. However, there are still no in vivo data about these concerns. The aim of this study was to evaluate 3.0-T magnetic field interactions of copper-containing IUDs in vivo. MATERIALS AND METHODS: Magnetic field interactions and potential adverse events were evaluated in 33 women using a questionnaire-based telephone survey. Two experienced radiologists performed artifact evaluation on MR images of the pelvis. RESULTS: Eighteen patients were eligible for the survey. One patient reported a dislocation of the IUD after the MR examination. All other patients had no signs of field interactions. No IUD-related artifacts were found. CONCLUSION: MRI at 3.0-T is possible for women with copper-containing IUDs. However, consulting a gynecologist to check the correct position of the IUD and exclude complications after an MR examination is highly recommended. High-quality clinical imaging of the female pelvis can be performed without a loss in image quality.
Adult ; Artifacts ; *Copper ; Female ; Hot Temperature ; Humans ; *Intrauterine Devices, Copper/adverse effects ; Magnetic Fields ; Magnetic Resonance Imaging/adverse effects/*methods ; Middle Aged ; Pelvis

To evaluate the long term effects of an IUD on the human endometrium and find the possible contraceptive mechanism of IUD, histologic, histochemical and ultrastructural studies of human endometrial biopsies from 44 normal controls and 178 IUD wearers were made. Histologic findings included interstitial hemorrhage, inflammatory reaction, hyperplasia, atrophy, focal necrosis and squamous metaplasia. However, all of these findings were either infreqnent or insignificant except for inflammatory reaction. Histochemica1, enzymatic and ultrastructural findings were a1so unremarkable. The most significant finding, was asynchronism between cyclic dating and endometrial histologic dating, showing delayed endometrial maturation in the majority of IUD users. In summary, IUD insertion brings about mild and little histologic alteration in the human endometrium, but the inflammatory reaction and asynchronous endometrial matruation may play some role in the antifertility actifertility action of an IUD.
Adult ; Comparative Study ; Endometriosis/etiology ; Endometriosis/ultrastructure ; Endometrium/ultrastructure* ; Female ; Human ; Intrauterine Devices/adverse effects* ; Middle Age ; Time Factors ; Uterine Diseases/etiology* ; Uterine Diseases/pathology