Risk-benefit assessment of onlay and retrorectus mesh augmentation for incisional hernia prophylaxis: A secondary analysis from network meta-analysis

Regulatory policies on drugs have a major impact on patient safety and survival. Some pharmaceutical companies employ all possible methods to achieve maximum sales in relation to the monopoly of their patented drugs, leading sometimes to irregularities and illegal activities. Misinformation on the orphan drug deferasirox has reached the stage of criminal investigations and fines exceeding USD 100 million. Additional lawsuits of USD 3.5 billion for damages and civil fines were also filed by the FBI of the USA involving deferasirox and mycophenolic acid, which were later settled with an additional fine of USD 390 million. Furthermore, a USD 345 million fine was also settled for bribes and other illegal overseas operations including an EU country. However, no similar fines for illegal practises or regulatory control violations have been issued in the EU. Misconceptions and a lack of clear guidelines for the use of deferasirox in comparison to deferiprone and deferoxamine appear to reduce the effective treatment prospects and to increase the toxicity risks for thalassaemia and other iron loaded patients. Similar issues have been raised for the activities of other pharmaceutical companies promoting the use of new patented versus generic drugs. Treatments for different categories of patients using new patented drugs are mostly market driven with no clear safeguards or guidelines for risk/benefit assessment indications or for individualised effective and safe optimum therapies. There is a need for the establishment of an international organisation, which can monitor and assess the risk/benefit assessment and marketing of drugs in the EU and globally for the benefit of patients. The pivotal role of the regulatory drug authorities and the prescribing physicians for identifying individualised optimum therapies is essential for improving the survival and safety of millions of patients worldwide.

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Risk-Benefit Assessment of Technology Transfer in the Poultry Industry

The Journal of Applied Poultry Research ◽

10.1093/japr/10.3.306 ◽

2001 ◽

Vol 10 (3) ◽

pp. 306-312

Author(s):

D.F. Calabotta

Keyword(s):

Technology Transfer ◽

Benefit Assessment ◽

Poultry Industry ◽

Risk Benefit Assessment

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Prevention of incisional hernia at the site of stoma closure with different reinforcing mesh types: a systematic review and meta-analysis

Hernia ◽

10.1007/s10029-021-02393-w ◽

2021 ◽

Author(s):

Roberto Peltrini ◽

Nicola Imperatore ◽

Gaia Altieri ◽

Simone Castiglioni ◽

Maria Michela Di Nuzzo ◽

...

Keyword(s):

Incisional Hernia ◽

Operative Time ◽

Meta Analysis ◽

Short Term ◽

Mesh Group ◽

Closure Technique ◽

Mesh Placement ◽

Mesh Reinforcement ◽

Significant Difference ◽

Significant Superiority

Abstract Purpose To evaluate safety and efficacy of a mesh reinforcement following stoma reversal to prevent stoma site incisional hernia (SSIH) and differences across the prostheses used. Methods A systematic search of PubMed/MEDLINE, EMBASE, SCOPUS and Cochrane databases was conducted to identify comparative studies until September 2020. A meta-analysis of postoperative outcomes and a network meta-analysis for a multiple comparison of the prostheses with each other were performed. Results Seven studies were included in the analysis (78.4% ileostomy and 21.6% colostomy) with a total of 1716 patients with (n = 684) or without (n = 1032) mesh. Mesh placement was associated with lower risk of SSIH (7.8%vs18.1%, OR0.266,95% CI 0.123–0.577, p < 0.001) than no mesh procedures but also with a longer operative time (SMD 0.941, 95% CI 0.462–1.421, p < 0.001). There was no statistically significant difference in terms of Surgical Site infection (11.5% vs 11.1%, OR 1.074, 95% CI 0.78–1.48, p = 0.66), seroma formation (4.4% vs 7.1%, OR 1.052, 95% CI 0.64–1.73, p = 0.84), anastomotic leakage (3.7% vs 2.7%, OR 1.598, 95% CI 0.846–3.019, p = 0.149) and length of stay (SMD − 0.579,95% CI − 1.261 to 0.102, p = 0.096) between mesh and no mesh groups. Use of prosthesis was associated with a significant lower need for a reoperation than no mesh group (8.1% vs 12.1%, OR 0.332, 95% CI 0.119–0.930, p = 0.036). Incidence of seroma is lower with biologic than polypropylene meshes but they showed a trend towards poor results compared with polypropylene or biosynthetic meshes. Conclusion Despite longer operative time, mesh prophylactic reinforcement at the site of stoma seems a safe and effective procedure with lower incidence of SSIH, need for reoperation and comparable short-term outcomes than standard closure technique. A significant superiority of a specific mesh type was not identified.

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