- Gene Therapy Improves Vision in People With Inherited Blindness
- Parental Deaths to Guns, Drugs Harmed Nearly 100,000 U.S. Kids in 2020
- Money Worries Top Seniors’ List of Health-Related Concerns: Poll
- Scientists Developing Vaccine Against Present and Future COVID Viruses
- ERs Often Missing Epilepsy in Kids With ‘Non-Motor’ Seizures
- Parents of Infants With Cystic Fibrosis Often Feel Confused, Unsupported: Survey
- Avoid Some ‘Project Watson’ Dog Eye Wipes Due to Infection Danger
- New Test Might Alert Pregnant Women to Preeclampsia Danger
- Combo Therapy May Be Advance Against Liver Cancer
- How ‘Unruly’ Sports Parents Harm Their Kids’ Mental Health
FDA Tightens Rules for Using Mesh Implants in Women’s Surgery
The U.S. Food and Drug Administration has strengthened rules regarding the use of vaginal mesh implants to treat pelvic organ prolapse in women.
The devices were reclassified on Monday from a “moderate” to “high” risk category. Manufacturers must now submit pre-market approval applications to the FDA to help the agency better assess the implants’ safety and effectiveness.
Pelvic organ prolapse involves a weakening or stretching of internal structures that support organs such as the bladder, bowel and uterus. It can happen in women after childbirth, a hysterectomy or menopause. It can cause pelvic pain, constipation and urinary leakage, and often affects sexual activity.
Surgeons have long used the mesh implants to reinforce weakened pelvic floor muscles and repair pelvic organ prolapse. But, problems afterwards such as pain, infection, bleeding, urinary problems and pain during intercourse are common, the agency said.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” Dr. William Maisel, deputy director of science and chief scientist at the FDA Center for Devices and Radiological Health, said in an agency news release.
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures,” he added.
The updated requirements apply to surgical placement of the mesh implants through the vagina (transvaginal) to treat pelvic organ prolapse. The new rules do not apply to other uses of surgical mesh.
Makers of transvaginal mesh implants already on the market now have 30 months to submit pre-market approval applications, while makers of new devices must submit an application before they can be approved for sale in the United States, the FDA said.
More information
The American Urogynecologic Society has more about pelvic organ prolapse.
Source: HealthDay
Copyright © 2024 HealthDay. All rights reserved.