New Delhi: The Modi government has written to American pharmaceutical giant Johnson & Johnson asking it to furnish details of the number of surgical pelvic meshes it has imported into India in the last three years.
The government’s move has been triggered by the U.S. Food and Drug Administration (FDA) ban on the transvaginal pelvic mesh last week.
“We have written to J&J to seek data on the number of mesh imported in India in the last three years. The company’s license expired last month (in March) and it also hasn’t submitted an application for renewal yet,” said a senior official at Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for drugs and medical devices.
The mesh is a medical device popularly used to support the abnormal descent of the pelvis in women. It is a cloth-like piece of netting made of synthetic material that is used to provide additional support to weakened or damaged tissue; for instance, after childbirth or due to increasing age.
While the government is examining the data on sales of the transvaginal mesh in India, it has figured out that not many such products are available here.
“A majority of the licenses have already expired and never came up for renewal. We are also checking with domestic manufacturers about their latest production numbers but they are also not actively manufacturing this product,” said the senior official quoted above. “Moreover, mesh makers such as Boston Scientific and Coloplast (under scanner in the US) were never registered for the import of mesh in India.”
Various sellers at Indiamart.com, an online marketplace, do, however, claim to sell pelvic mesh.
“Our regulators approve import of notified medical devices on basis of US FDA regulatory approval as shortcuts. They have confidence in the regulatory processes of the USA and the European Union,” said Rajiv Nath, forum coordinator of the Indian Medical Device Industry.
“Hence, when these countries ban the sale of specific devices, Indian regulators also need to cancel import licenses (if any active) and otherwise, impose an official ban to protect the public.”
ThePrint reached J&J, through email, to confirm whether the company had received the letter from CDSCO but there was no response despite repeated reminders. This report will be updated when J&J responds.
Controversial mesh products that J&J has launched in India
In India, J&J registered its product as “Gynecare Gynemesh PS” in 2011 but the licence expired in 2013. It renewed the license, which expired in 2016 and then in 2019.
While the product was launched as a transvaginal mesh, the company made significant changes in its controversial Gynecare product after increased complaints and class action suits against it.
It changed the way that mesh is implanted, from a transvaginal approach to a transabdominal one.
“The product is no more available for transvaginal administration but we need to check if the doctors are still using it through vaginal insertions, which will be its off label use,” said the CDSCO official.
Till February 2019, J&J’s Ethicon had around 34,800 vaginal mesh lawsuits where many women have named the company’s Gynecare TVT Abbrevo product as responsible for their injuries, according to ConsumerSafety.org, an organisation that provides legal help to individuals suffering the consequences of problematic medical devices.
The same product was also registered in India between 2014 and 2017. However, there is no clarity if the registration was renewed as data on the CDSCO’s website has not been updated for 2017 and 2018.
“We have written to the company to share the sales and imports of all pelvic mesh to gain further clarity,” the official said.