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Submit report on any adverse reaction to pelvic mesh, J&J told

Days after the U.S. Food and Drug Administration (FDA) banned surgical pelvic meshes — used to support the abnormal descent of the pelvis in women — following reports of adverse reactions, the Union Health Ministry has written to pharmaceutical giant Johnson & Johnson seeking information on the import, sale and stock of the product in the last three years.

“We have also requested for information/report on any adverse reactions,’’ said a senior health official.

The Ministry is also looking at the fact that the company’s licence to import it expired in March 2019 and it hasn’t come up for renewal yet.

While the Indian manufactures claim that they aren’t making vaginal mesh, an official added that other international mesh makers — Boston Scientific and Coloplast — were not registered for the import of mesh in India.

Seeking an immediate ban on the use of the product, Rajiv Nath, forum coordinator of the Indian Medical Device Industry, said: “Our regulators approve import of notified medical devices on the basis of the USFDA and other such regulatory approval so when these countries ban specific devices, Indian regulators too need to automatically cancel import licences and impose the same restrictions. It is distressing when these reputed overseas manufactures continue to sell in India suspect quality batches of products that they have recalled or been asked to recall by their regulatory authority abroad.’’

Explained Malini Aisola, health researcher, co-convenor of the All India Drug Action Network (AIDAN): “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. Given the horrific adverse events associated with the pelvic mesh in Western countries which has led to the ban, the Indian regulatory body must take immediate measures to protect patients — by initiating local investigations and issuing show cause notices on the way to ordering mandatory withdrawal of these products.’’

She added that it was tragically ironic that the Indian regulator willingly relies on the decisions of foreign regulatory authorities to grant companies access to the market, but was reluctant to act on the decisions of those same agencies to protect patient safety.

Source: thehindu.com

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