About Transvaginal Mesh
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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