Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine

Abstract

The use of synthetic mesh to augment vaginal repair procedures for pelvic organ prolapse has increased in large part because of dissatisfaction with the success rates of traditional colporrhaphy. Its use, however, is controversial. Four randomized controlled studies comparing traditional colporrhaphy with vaginal repair using mesh augmentation had conflicting results. This unblinded, prospective, randomized controlled trial investigated whether mesh augmentation during vaginal repair would reduce the rate of recurrent prolapse at 12 months compared with traditional colporrhaphy. A total of 139 women with stage 2 or more prolapse who required both anterior and posterior compartment repair were randomized to mesh augmentation (mesh group, n ϭ 69) or colporrhaphy (no mesh group, n ϭ 70). Study subjects were enrolled between 2003 and 2005 at a tertiary teaching hospital. Prolapse was staged using the pelvic-organ-prolapse quantification (POP-Q) system. The primary study outcome was objective success of surgery defined as the absence of POP-Q stage 2 or more prolapse at 12 months following surgery. Questionnaires were used to assess secondary outcomes including symptoms, quality of life, and patient satisfaction.Of the 139 women, 63 of 69 (93.1%) in the mesh group and 61 of 70 (87.1%) in the no mesh group attended the 12-month follow-up. There was no significant difference at 12 months in objective success (POP-Q stage 0 or 1) between the mesh and no mesh groups (mesh: 81.0% ͓51/63͔ vs. no mesh: 65.6% ͓40/61͔; P ϭ 0.07). Although patients in both groups expressed a high level of satisfaction with the surgery and improved symptoms and parameters of quality of life compared to baseline, there was no statistically significant difference in these outcomes between the 2 groups (P ϭ ns). Postoperative complications in the mesh group included four cases (5.6%) of vaginal mesh exposure. At 12 months, de novo dyspareunia was reported in 27.8% (5/18) of the sexually active women without preoperative dyspareunia in the mesh group and in 41.7% (5/12) of those in the no mesh group. These differences were not significant (P ϭ 0.46).These findings show that anterior and posterior vaginal repair with mesh augmentation at 12 months after surgery does not result in significantly less recurrent prolapse than traditional colporrhaphy. GYNECOLOGY Volume 64, Number 12 OBSTETRICAL AND GYNECOLOGICAL SURVEY ABSTRACTThe presence of myomas can impair fertility. To preserve fertility in women with myomas wanting to become pregnant, myomectomy can be performed with laparotomy, laparoscopy, or hysteroscopy and achieve pregnancy rates of up to 70%. Advantages of laparoscopic techniques compared with laparotomy include shorter hospital stay, more rapid recovery, and less intra-abdominal adhesions. In addition, the overall complication rate is lower. Precise dissection and suturing, however, is especially difficult with traditional laparoscopy for myomas with a deep intramural and/or another unfavorable localization that have a probable impact on fec...

Prophylaxis of Cervical Cancer and Related Cervical Disease: A Review of the Cost-Effectiveness of Vaccination Against Oncogenic HPV Types

“…Yet, a recent analysis of the quadrivalent vaccine found that the overall rates of adverse events were not greater after HPV vaccination compared with background rates following other types of vaccination. 56 However, a disproportionate number of syncope and venous thrombolic events were observed after HPV vaccination. The venous thrombolic events reported fell within a large time window postvaccination, and 90% of subjects reported having pre-existing risk factors.…”

“…4 Persistent infection with an oncogenic strain of HPV is the known cause of cervical cancer, 5 the second most common cancer in women worldwide. Of the 40 HPV types that affect the genital area, at least 15 types are known to be oncogenic (types 16,18,31,33,35,39,45,51,52,56,58,59, 68, 73, and 82). 6 The strength of the association between HPV and cervical cancer is at least 10 times greater than the association between smoking and lung cancer.…”

“…Infection with an oncogenic human papillomavirus (HPV) type is the known cause of cervical cancer. Of the 40 HPV types that infect the genital mucosa, 15 are known to be oncogenic (types 16,18,31,33,35,39,45,51,52,56,58,59,68,73, and 82). Two vaccines have proven efficacy against types 16 and 18, which account for 70% of cervical cancer cases worldwide.…”

Immunogenicity and Safety of a 9-Valent HPV Vaccine

“…Data have shown that prophylactic HPV vaccination is generally safe and well tolerated. [32][33][34][35][36][37][38] The median age of sexual debut is in the late teens (15-19 years) in most countries. 39 Virginal adolescents (#15 years old) were not included in HPV vaccine efficacy evaluations because of low HPV exposure and ethical constraints.…”

Internet-Based Reporting to the Vaccine Adverse Event Reporting System: A More Timely and Complete Way for Providers to Support Vaccine Safety

“…2,[7][8][9] Additional objectives of VAERS include monitoring the safety of newly licensed vaccines, 10 assessing potential risk factors for adverse reactions to vaccines, and ultimately improving the safety of vaccines and vaccination practices. VAERS 1-page reporting form collects demographic information about the reporter and the patient as well as a narrative and clinical descriptors regarding AEs.…”