Most Well-Known Product Recalls by US Vaginal Sling Device Makers Two of the world’s bladder sling developers from the United States, Boston Scientific and Johnson & Johnson, seem to have been affected by all-out product recalls, online media reports. Research reveals that the firms’ move to recall their products have been due to unusually high failure rates, post-surgery injury reports, and a growing public outcry against complications. Mesh devices, also known as vaginal or bladder slings, are often transvaginally inserted in women in surgical procedures as means to address pain and discomfort from disorders that involve the bladder or the pelvis, according to medical experts. Initially designed and used to treat abdominal hernias in the 1950s, medical devices now known as vaginal meshes or bladder slings were cut and reformed into the appropriate shape that would work as support to women affected by stress urinary incontinence (SUI) – a condition of uncontrollable urinary leaks, and pelvic organ prolapse (POP) – a disorder that occurs when pelvic organs move or shift from their places. However, these medical devices have been surrounded with different controversies, increasing post-surgery complication complaints, and a slew of lawsuits brought by women from different parts of the country against major device makers. Constantly growing number of complaints corresponding to malfunction and injuries such as device erosion, organ perforation, bleeding, debilitating pelvic pain, and painful sexual intercourse have been reported and received by the US Food and Drug Administration. It was only a matter of time,
particularly in 1999, when the a major surgical mesh manufacturer first came to the decision of a product recall due to safety issues tied to their device. The first surgical mesh product to have been recalled was the ProteGen Vaginal Sling by Boston Scientific, online media reports, explaining that the move was conducted in response to unusually high device failure rates, and postimplantation complication complaints, reaching up to 500 between the time it was used and recalled. Boston Scientific removed another one of their pelvic sling products from the market in August 2011, a bladder repair sling known as Pinnacle Pelvic Floor Repair Kit, because of mechanical concerns. ObTape, a bladder sling distributed in the American consumer market in 2003, was also reported with safety concerns by women who have received them in surgery, according to online news reports. Manufactured by Mentor Corporation (a company that was eventually acquired by Johnson & Johnson), the firm has also reportedly discontinued sales of ObTape, without completely removing all ObTape products from the market, in 2006. At the height of injury complaints involving four of their vaginal sling products, Johnson & Johnson\â€™s (J&J) division, Ethicon, has also decided to discontinue selling Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift, and Gynecare Prolift+M in July 2012 â€” a vaginal sling device recall anticipated by most legal experts to fully take effect in the first quarter of 2013. In a 2011 Safety Communication by the US FDA, the agency highlight an increasing number of adverse-event reports linked to the use of bladder slings for POP repair. See bladderslingrecall.us to know more about mesh slings and the potential hazards they have been reported to cause. Sources: everydayhealth.com/health-center/pelvic-organ-prolapse.aspx fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ UroGynSurgicalMesh/ucm284109.htm health.usnews.com/usnews/health/articles/020729/archive_022087.htm accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=100416 imb.ie/images/uploaded/documents/fsn/FSNMay2011/V11930_FSN.pdf nytimes.com/2009/05/05/health/05tape.html?pagewanted=all&_r=0 bloomberg.com/news/2012-06-04/j-j-tells-judge-it-will-stop-selling-vaginal-mesh-
Published on Jan 19, 2013
In a 2011 Safety Communication by the US FDA, the agency highlight an increasing number of adverse-event reports linked to the use of bladde...