What is Transvaginal Mesh?
This implant is made of a synthetic net-like material and it is used to add support to damaged tissues or organs. Transvaginal refers to the method of implantation, and means via the vagina. This is a less invasive and quicker alternative to some more dangerous surgery options, which is what makes it so popular. This implant has been commonly used to treat POP (pelvic organ prolapse) and SUI (stress urinary incontinence). These conditions usually develop in women whom have just recently undergone child birth, a hysterectomy, or menopause.
Given that these health conditions are far from rare, millions of women across the United States have been on the receiving end of this implant. This device was designed to provide relief for the suffering cause by POP or SUI; however relief is not always achieved. The FDA tells us that this device which is manufactured by several different companies may be associated with some serious and harmful complications and side effects.
What are Common Transvaginal Mesh Side Effects?
Complications of this device are not rare, in fact tens of thousands of Transvaginal Mesh lawsuits are still pending (don’t minimize injuries that actually are serious…). Some of the more common injuries include urinary problems, irregular bleeding, pain during intercourse, and chronic pain and infection.
The most serious issues related to the device are erosion and exposure of the mesh, recto vaginal fistula, and reoccurrence of POP and SUI. The FDA has received thousands of reports throughout the life of the implant regarding negative reactions. In some instances the reactions may have even required additional medical care and even revision surgery. This now turns a quick and minimally invasive procedure into a drawn out process.
Questioning the Safety of this Implant and the FDA’s Approval…
The FDA (U.S food and drug administration) utilized a process known as a 510(k) in the approval of this device. This process simply allows the approval based on the fact that the product is substantially similar to a product that has previously been approved and is in the market. Transvaginal Mesh was similar enough to another product which had already been approved and therefore with minimal review it passed the test. This means that there is an inherent lack of knowledge regarding the safety and effectiveness of the product.
In this case it could be argued that the device should only be implanted in scenarios such as an investigative trial and only when the patient is fully aware of all the risks involved with the procedure and still consents. After the FDA became more aware of the issues surrounding the implant they released advisory warnings regarding the product, and their research continues.
Talk to a Lawyer About Filing a Transvaginal Mesh Lawsuit?
Patients that are suffering from injury related to the implant may be compensated for their damages such as; additional surgery, medical bills, lost wages, emotional distress, pain and suffering and more… As more information continues to emerge regarding this product the litigation continues to grow. If you are a loved one have suffered from an unfortunate complication which you believe may be linked to a Transvaginal Mesh implant you may be entitled to compensation for your injuries.
It is very important to get in contact with a well-versed personal injury attorney that can help you with your possible claim. You will need an attorney that is knowledgeable regarding these particular cases in order to receive legal help that you can trust. d’Oliveira & Associates is working with some experienced Transvaginal Mesh attorneys across the country and will be able to provide you with the help that you need.
Feel free to contact us at 1-800-992-6878, stop by one of our 15 locations, or fill out a contact form for a free legal consultation. There are no legal fees until you receive a settlement or award.