Obstetric and gynecological devices associated with adverse incidents Save

Obstetric and Gynecological Devices Associated with Adverse Incidents

Obstetric and gynecological devices are widely used to diagnose, treat, and manage various conditions related to women's health. However, some of these devices have been associated with adverse incidents that can cause harm to patients. It's important to be aware of these devices and their potential risks to make informed decisions about your healthcare.

1. Transvaginal Mesh: Transvaginal mesh is a surgical mesh implanted to treat pelvic organ prolapse and stress urinary incontinence in women. However, the mesh has been linked to severe complications such as erosion, infection, and chronic pain. The FDA has issued warnings about the use of transvaginal mesh and has required manufacturers to conduct post-market studies to evaluate the safety and effectiveness of the devices.
2. Power Morcellator: Power morcellators are surgical devices used to remove uterine fibroids or perform a hysterectomy. However, the use of power morcellators has been associated with the spread of undiagnosed uterine cancer, leading to advanced and difficult to treat cancer. The FDA has issued a warning against the use of power morcellators in women with suspected uterine cancer.
3. Essure: Essure is a permanent birth control device implanted into the fallopian tubes. However, the device has been linked to severe complications such as chronic pain, perforation of organs, and migration of the device. The FDA has required a black box warning on the device and restricted its use to women who have been fully informed of the potential risks.

It's important to talk to your healthcare provider about any obstetric or gynecological devices that you may need. Ask about the potential risks and benefits of the device and weigh your options carefully. If you have experienced any adverse incidents related to these devices, report them to the FDA's MedWatch program to help improve patient safety.