Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study

Journal BMJ
Authors Mao J, Pfeifer S, Schlegel P, & Sedrakyan A.
Year Published 2015
Link to publication

Abstract

Female sterilization is one of the most commonly used methods of contraception, and is traditionally performed via laparoscopy to ligate fallopian tubes of both sides. Since the introduction of the Essure device 12 years ago, interval sterilization can be also performed by inserting the device with hysteroscopy. With the increasing use of Essure, there have been reports to the FDA of adverse events, and the efficacy has also been questioned. The present study compared the safety and efficacy of Essure-based hysteroscopic sterilization to the traditional laparoscopic procedure. Short-term adverse events following both procedures were rare. Hysteroscopic and laparoscopic sterilization also had similar risks of unintended pregnancy following surgery. However, the Essure procedure was associated with a 10 times higher risk of reoperation within the first year following surgery.

 

Transvenous implantable cardioverter-defibrillator lead reliability: implications for postmarket surveillance

Journal Journal of the American Heart Association
Authors D.B. Kramer, L. Hatfield, D. McGriff, C.R. Ellis, M.T. Gura, M. Samuel, L.K. Retel, R.G. Hauser
Year Published 2015
Link to article

METHODS/RESULTS: We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow-up

CONCLUSIONS: Currently marketed implantable cardioverter-defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter-defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.

Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal of evidence

Journal BMJ
Authors Sedrakyan, Art; Normand, Sharon-Lise; Dabic, Stefan; Jacobs, Samantha; Graves, Stephen; Marinac-Dabic, Danica
Year Published 2011
Link to article

Abstract

OBJECTIVE: To determine comparative safety and effectiveness of combinations of bearing surfaces of hip implants.

DESIGN: Systematic review of clinical trials, observational studies, and registries.

DATA SOURCES: Medline, Embase, Cochrane Controlled Trials Register, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the United States Food and Drug Administration.

STUDY SELECTION: Criteria for inclusion were comparative studies in adults reporting information for various combinations of bearings (such as metal on metal and ceramic on ceramic). Data search, abstraction, and analyses were independently performed and confirmed by at least two authors. Qualitative data syntheses were performed.

RESULTS: There were 3139 patients and 3404 hips enrolled in 18 comparative studies and over 830‚ÄČ000 operations in national registries. The mean age range in the trials was 42-71, and 26-88% were women. Disease specific functional outcomes and general quality of life scores were no different or they favoured patients receiving metal on polyethylene rather than metal on metal in the trials. While one clinical study reported fewer dislocations associated with metal on metal implants, in the three largest national registries there was evidence of higher rates of implant revision associated with metal on metal implants compared with metal on polyethylene. One trial reported fewer revisions with ceramic on ceramic compared with metal on polyethylene implants, but data from national registries did not support this finding.

CONCLUSIONS: There is limited evidence regarding comparative effectiveness of various hip implant bearings. Results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.

A multinational assessment of metal-on-metal bearings in hip replacement

Journal Journal of Bone and Joint Surgery, American Volume
Authors Graves, Stephen; Rothwell, Alastair; Tucker, Keith; Jacobs, Joshua; Sedrakyan, Art
Year Published 2011
Link to article

Abstract

There is emerging evidence that many metal-on-metal (MoM) bearings, when used with large femoral heads in conventional hip replacement and some resurfacing prostheses, are associated with increased rates of revision arthroplasty. Registries are the main sources of data on MoM prostheses. At the recent International Consortium of Orthopaedic Registries (ICOR) meeting, data were presented from the Australian, England and Wales, and New Zealand registries. All registries reported an increased rate of revision for large femoral head MoM prostheses when prostheses were aggregated compared with the aggregated data of hip prostheses with other bearing surfaces. There was also evidence, however, that the outcome varied, depending on the type of prostheses used, in both large femoral head MoM conventional hip replacement as well as resurfacing hip replacement.The relevance of the recent isolated case reports on systemic metal toxicity was also discussed at the ICOR meeting. Although systemic metal toxicity appears to be a rare occurrence, there is a need to undertake appropriately designed studies to define the true prevalence of this phenomenon. There may be advantages in nesting these studies within registries. The ICOR meeting highlighted the implications of the MoM experience for the orthopaedic industry, regulators, and surgeons.