FDA Group Wants Restrictions on Surgical Mesh Securing Women's Pelvic Organs
![Pelvic Prolapse](https://d.medicaldaily.com/en/full/221366/pelvic-prolapse.jpg?w=450&f=9f378f8200e1b15989a405ef0a22d6a8)
It’s a surgical procedure performed on 75,000 U.S. women in 2010 which had seen over 1,500 “adverse” painful and uncomfortable outcomes in the two prior years.
On Friday, a group of experts convened by the Food and Drug Administration told the governmental body that certain mesh products inserted through the vagina and set surgically to prevent women’s pelvic organs from moving out of place, or prolapsing, must be put through clinical studies and be subject to tougher rules.
Currently, the mesh products do not require clinical trials.
Companies making the product include American Medical Systems, Inc., C.R. Bard, and Johnson & Johnson.
Advocacy group Public Citizen said ahead of Friday’s decision that reclassifying the products as “class III medical devices” so that clinical trials are required was a step in the right direction but not good enough. The group urged the FDA “immediately ban” the products and require a recall of what it called “dangerous and ineffective devices.”
“It is difficult to conceive how any further clinical trial could enroll and randomize patients to receive these operations with surgical mesh based on the knowledge that we already have,” said Dr. L. Lewis Wall, a professor of obstetrics and gynecology and a bioethicist at Washington University in St. Louis who was also a co-petitioner on Public Citizen’s petition.
Pelvic Organ Prolapse (POP) involves the bulging or descent of one or more pelvic organs, such as the bladder, rectum or uterus in the vagina, and sometimes past the opening of the vagina, Public Citizen noted. The result arises from weakness in the connective tissue and muscles surrounding the pelvic organs.
In 2008, the FDA warned of adverse effects such as the mesh becoming exposed or protruding out of the vaginal tissue, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure and urinary problems.
Some reports the FDA became aware of indicated that that additional surgeries were required or hospitalization was needed to treat complications or to remove the mesh.
From 2008 to 2010, the FDA received 1503 "adverse event reports" associated with mesh used for POP repair, five times as many as it received from 2005 to 2007. POP procedures numbered 100,000 in 2010, with three quarters of those being transvaginal procedures.
That type of surgery was the focus of Friday’s announcement.
The experts, with backgrounds in obstetrics and gynecology met on Thursday and Friday to discuss the effectiveness and safety of surgical mesh used to treat POP and stress urinary incontinence (SUI), which entails urine leakage during physical activity.
If the FDA goes forward with stricter requirements, the products, which are inserted through the vagina, would be placed in a category requiring clinical trials and an application seeking the FDA’s approval.
The FDA warned in July that placing the mesh through the vagina to repair POP may expose patients to greater risk than other surgical options. The greater risk comes with no evidence of greater clinical benefit such as improved quality of life, the FDA said.
An FDA expert said in July that the mesh under consideration is a “permanent implant – complete removal may not be possible and may not result in complete resolution of complications.”