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About Transvaginal Mesh Complications


Surgical mesh is a medical device that is used to provide extra support when repairing weakened or damaged tissue. Most surgical mesh devices are made from synthetic materials or animal tissue.


It is a cloth-like piece of netting made of synthetic material that is used to support the abnormal descent of the pelvis in women; for instance, after childbirth or due to increasing age or hernia.


Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.


Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.


The US FDA has stopped the sale of the surgical mesh. Indian government is also reviewing the situation. “The mesh is among the 23 regulated medical devices in India and a committee has been formed to discuss the US FDA move and its relevance to India.”


In India, however, several players sell these devices. According to an analysis by the All India Drug Action Network (AIDAN), an NGO, the CDSCO has granted registration certificates to over 10 companies to import the mesh.


“As per AIDAN’s analysis, a number of mesh products for use in hernia repair, urinary incontinence and prolapse repair have been approved in India,” said Malini Aisola, co-convenor of AIDAN.


“Given the horrific adverse events associated with the mesh in Western countries, which has led to the US ban, the CDSCO must take immediate measures to protect Indian patients by initiating local investigations and issuing showcause notices before ordering the mandatory withdrawal of these products from India,” she said.


As per Mr Rajiv Nath, forum coordinator of the Indian Medical Device Industry. the move to curb import of unsafe vaginal mesh is overdue, especially after a Netflix documentary and investigative report by a newspaper.


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