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US FDA rules manufacturers to stop selling mesh devices
| Content Provider | Semantic Scholar |
|---|---|
| Author | Holt, Ed |
| Copyright Year | 2019 |
| Abstract | For more on the study by Glazener and colleagues see Articles Lancet 2017; 389: 381–392 Ja so n Re ed The US Food and Drug Administration (FDA) ruled on April 16 that two compa nies must stop selling and distributing all remaining surgical mesh products for pelvic organ prolapse repair. “...the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices”, the agency said in a press release. To support a favourable benefit-risk profile, the companies had been asked to demonstrate that surgical mesh for transvaginal repair is more effective than and had comparable safety outcomes to native tissue repair at 36 months. This announcement comes after warnings had been released by the FDA due to “a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal [pelvic organ prolapse] repair”, the agency said. Boston Scientific and Coloplast were not available for interview, but they have issued press releases warning that the move will limit treatment options for women. Controversy has surrounded vaginal mesh surgery for decades. In the USA alone, thousands of lawsuits pertaining to transvaginal mesh have been filed, according to legal firms across the country and national media reports, and patient lobby groups around the world say that women have had their lives devastated by complications related to the surgery. Reported problems include pain (including painful sexual intercourse, known as dyspareunia), infection, urinary problems, bleeding, and organ perforation. Cathryn Glazener, an emeritus professor at University of Aberdeen, who co-authored a study published by The Lancet in 2016 that compared native tissue prolapse repair, use of a synthetic mesh, and biological grafts during prolapse surgery, told The Lancet: “This raises the question of why someone having a first repair would undergo such a procedure when there is now mounting evidence of extra problems with mesh products.” |
| File Format | PDF HTM / HTML |
| DOI | 10.1016/S0140-6736(19)30938-9 |
| PubMed reference number | 31034366 |
| Journal | Medline |
| Volume Number | 393 |
| Alternate Webpage(s) | https://api.elsevier.com/content/article/pii/S0140673619309389 |
| Alternate Webpage(s) | https://www.sciencedirect.com/science/article/pii/S0140673619309389?dgcid=api_sd_search-api-endpoint |
| Alternate Webpage(s) | https://doi.org/10.1016/S0140-6736%2819%2930938-9 |
| Journal | The Lancet |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
