Johnson & Johnson (J&J) and C.R. Bard Inc. have to carry more clinical studies and present more safety data on the transvaginal mesh used to treat prolapsed pelvic organ, FDA said on Friday.
The recent controversy over the transvaginal mesh led to 500 lawsuits against J&J and other companies due to internal injuries caused by the meshes.
Pelvic Organ Prolapse
Pelvic organ prolapse is a painful condition which occurs when the pelvic organ in a female body drops down from its normal position usually due to weakening of the vaginal wall due to childbirth, hysterectomy and menopause. It is common for women of all ages but after giving natural birth, chances of pelvic organ prolapse increases.
Transvaginal mesh is known to give support to the weakened muscle of the pelvic organ to hold it in the right place. However, the mesh produced by J&J and C.R. Bard lacked enough data to prove its efficiency and safety, FDA said.
Thursday, after receiving several reports of injury and seven deaths, the FDA advisory panel recommended the two alleged companies to conduct more clinical studies and put mesh products in the highest-risk category of medical devices.
Until now the pelvic organ prolapse (POP) surgical mesh products were in the Class II medical devices in the 501(k) approval process. As per the regulation, manufacturers were required to show that the meshes were substantially equivalent to an existing device on the market. No preclinical test of the product was required.
Products approved by the 510(k) started being questioned when in July the Institute of Medicine, an independent group that advises the government on health policy, issued a record to the FDA to cross-check the risks and benefits of the products.
According to the FDA, surgery for transvaginal mesh is associated with risks like organ perforation and bleeding and in the long run can cause mesh exposure into the vagina, bladder or rectum, with clinical sequelae that include pelvic pain, infection, painful sex for patient or partner and the need for additional corrective surgeries.
Last year almost 75,000 transvaginal mesh surgeries were conducted in the U.S. despite a lack of sufficient clinical data, said the FDA.