Frequently Asked Questions - Transvaginal Mesh Complications
1. How did Avaulta mesh products get FDA approval?
The Avaulta products received expedited approval from the FDA through a legal loophole known as the 510(k) process. Through the FDA’s 510(k) process, a manufacturer certifies that its product is substantially equivalent to another legally marketed product, avoiding the more lengthy pre-market approval process. By going this route, Bard, the manufacturer of Avaulta surgical mesh products, did not have to demonstrate the safety of their vaginal mesh products through clinical trials prior to their release on the market.
The FDA’s oversight of medical devices has been called into question by auditors with the U.S. General Accounting Office. In 2009, federal auditors listed the FDA’s oversight of medical devices as a high-risk area warranting the attention of Congress.
2. Has the FDA recalled Avaulta?
No, the U.S. Food and Drug Administration has not ordered a recall of the Avaulta surgical mesh products. But in October 2008 and February 2009, the FDA issued warnings to physicians and healthcare providers that women implanted with vaginal mesh may suffer serious complications, including mesh erosion, pain, infection, urinary problems and puncture of the bladder or bowel. The FDA said it had received more than 1,000 reports of complications from nine manufacturers. They include Bard. The FDA said patients should be informed that some complications may require additional surgery and some complications may affect a woman’s quality of life.
If your quality of life has been harmed by mesh complications, a compassionate mesh injury attorney at Blasingame, Burch, Garrard, and Ashley P.C., may be able to help you. Contact us for a no-obligation confidential review of your case by calling toll-free at 877-312-1753 or using our convenient online form.
3. What are the complications commonly associated with vaginal surgical mesh?
You may experience a number of serious complications after having a transvaginal mesh sling implanted to repair dropped pelvic organs or relieve stress urinary incontinence. The surgical mesh can cause vaginal infection, abscesses, spotting, urinary leakage, bowel or bladder dysfunction, scarring, pain and altered pelvic anatomy. Unfortunately, some women have to undergo repeat surgeries and have the mesh removed.
4. Since I had pelvic surgery to correct a dropped bladder and urinary leakage, sexual intercourse has become very painful. That has harmed my marriage. Why wasn’t I told that this was a potential complication?
Patients should be told about the potential complications before undergoing surgery for vaginal prolapse or urge incontinence so they can make an informed decision. Medical device manufacturers that don’t provide accurate information to doctors or women about the risks and potential side effects of their products should be held accountable. The implanting of transvaginal mesh poses the risk of several qualify-of-life issues, including the loss of enjoyment of physical intimacy. Some women report pain during intercourse after having the mesh implanted. Fortunately, the law gives legal rights to people who are harmed by defective medical devices to seek compensation for their injuries.
5. How much will it cost for you to review my medical records and advise me on whether I have a case?
In cases involving personal injury and defective medical devices such as defective surgical mesh, you do not pay an attorney’s fee unless we collect money. This kind of arrangement, known as a contingency fee arrangement, allows injured patients to get the same high quality legal representation as medical device manufacturers. If you decide to hire us, we’ll thoroughly research your case and aggressively represent you. We believe that negligent medical device manufactures that put profits ahead of patient safety should be held accountable for the harm they cause. If we obtain compensation for you, we’ll receive a portion of the settlement agreed upon in advance.
At Blasingame, Burch, Garrard, and Ashley P.C., we understand the serious medical complications of transvaginal mesh products and work aggressively to help women regain their quality of life. A defective transvaginal mesh product lawyer will provide you with a free and confidential review of your case. You may be entitled to compensation for the harm or complications you’ve suffered. Our law firm is based in Athens, Georgia and we represent clients injured by Bard Avaulta products nationwide. Contact us for a no-obligation confidential review of your case by calling toll-free at 877-312-1753 or using our convenient online form.
6. How do you know if a doctor used an Avaulta product during your procedure?
We ask each prospective client to obtain her product implant sticker from the hospital in which the pelvic procedure was performed. The operating room nurse recorded on your medical record the name of the mesh used and its catalog number, lot number and size. This information should be included in the medical records you received from the hospital and doctor.
7. What are the different types of pelvic organ prolapse?
One or more organs may fall out of place and put pressure on the vagina if the pelvic muscles and ligaments are weakened. Pelvic organ prolapse has different names depending on which organ drops or falls. The condition is known as cystocele or bladder prolapse if the bladder drops, uterine prolapse, rectocele or rectal prolapse, and enterocele if the small bowel prolapses. Vaginal prolapse may occur after a woman has a hysterectomy or after childbirth.
Contact Our Defective Transvaginal Mesh Product Lawyers Today
The product injury lawyers of Blasingame, Burch, Garrard & Ashley, P.C. are dedicated to delivering answers and financial relief for women who have suffered injuries from these faulty mesh products, including compensation for medical expenses, lost income, physical pain and emotional suffering. We recently settled a group of mesh product cases for over 100 women after one week of trial in federal court.
We are an Athens, Georgia-based law firm that has been widely recognized for our ethics, skill and professionalism by Martindale-Hubbell®, The Best Lawyers in America, American College of Trial Lawyers, Super Lawyers and Law & Politics Media/Atlanta Magazine. Since 2006, our defective transvaginal mesh product lawyers have used their expertise and resources to secure recoveries for women in the U.S. and Canada who have been injured by defective surgical mesh products.
If you believe you are or a loved one is suffering complications from a transvaginal mesh product, such as the Bard Avaulta Solo, Avaulta Plus and Avaulta Biosynthetic systems, contact us today for a free case evaluation by calling us toll-free at 877-312-1753 or using our convenient online form. We have trained, female consultants available to discuss your situation and circumstances confidentially. Because we represent clients on a contingency fee basis, we will advance all expenses throughout the lawsuit process.
