First Mesh Implant Case Earns $5.5 Million in Damages
August 14, 2012 By Hecht, Kleeger & Damashek, PC
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For some time, the FDA has been aware of side effects related to vaginal mesh implants. The first case involving these side effects went to trial in California and earned a multi-million dollar settlement. According to the FDA, complications with vaginal mesh implants are not uncommon. A vaginal mesh (also known as an urogynecologic surgical mesh implant) is a medical product used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
In short, the implants are permanently implanted to reinforce the vaginal wall or support the neck or the bladder. Last year, the FDA issued a safety communication to health care providers explaining that vaginal mesh implants may not be as safe or effective as the medical community thought they were. In fact, these implants are prone to erosion and other serious side effects. Some women complained that the implants shrank or tightened over time, causing discomfort, pain and other side effects.
Although the FDA has known of these risks, the first vaginal mesh cases as settled in California last month. C.R. Bard, a medical product developing and manufacturing company, will pay a woman and her husband $5.5 million in damages for the pain and stress caused by a faulty vaginal mesh implant. Originally, the couple’s attorney asked the jury to give the husband and wife an $11 million settlement. “They seemed to focus on evidence we produced showing that Bard didn’t properly test the product before putting it on the mark,” the couple’s attorney said about the case. This is the first vaginal mesh implant case that has gone to trial, although hundreds of complaints have been filed about the faulty product. According to the FDA, no particular brand is any more defective than the rest – the basic design of the mesh seems to be faulty.
According to news sources, the officials from C.R. Bard are disappointed and do not believe that their company should be held responsible for the side effects suffered by the woman. “While we empathize with the complication suffered by the plaintiff,” said a spokesman for Bard, “those complications are not the fault of than y conduct by the company. We believe the evidence establishes that our Avaulta mesh products, cleared by the FDA, are safe and effective and provide significant benefits to patients.” Although the product was cleared by the FDA, it is labeled as posing a high risk to patients. This conclusion is based on information gathered from patient complaints between 2008 and 2010. This January, the FDA asked Bard (along with 30 other medical manufacturers) to study rates of damage inflicted by vaginal mesh implants.
ABOUT THE AUTHOR: Hecht Kleeger & Damashek
At Hecht Kleeger & Damashek (HKD), we are whole-heartedly dedicated to giving our clients the high-quaulity legal representation they need. If you’ve suffered the adverse side effects of a vaginal mesh implant, we want to help you collect damages for your pain and suffering. Our lawyers are well-versed in the ins and outs of product liability cases and are ready to help you stand up for your legal rights in court.
Copyright Hecht, Kleeger & Damashek, PC
More information about Hecht, Kleeger & Damashek, PC
Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.
Although the FDA has known of these risks, the first vaginal mesh cases as settled in California last month. C.R. Bard, a medical product developing and manufacturing company, will pay a woman and her husband $5.5 million in damages for the pain and stress caused by a faulty vaginal mesh implant. Originally, the couple’s attorney asked the jury to give the husband and wife an $11 million settlement. “They seemed to focus on evidence we produced showing that Bard didn’t properly test the product before putting it on the mark,” the couple’s attorney said about the case. This is the first vaginal mesh implant case that has gone to trial, although hundreds of complaints have been filed about the faulty product. According to the FDA, no particular brand is any more defective than the rest – the basic design of the mesh seems to be faulty.
According to news sources, the officials from C.R. Bard are disappointed and do not believe that their company should be held responsible for the side effects suffered by the woman. “While we empathize with the complication suffered by the plaintiff,” said a spokesman for Bard, “those complications are not the fault of than y conduct by the company. We believe the evidence establishes that our Avaulta mesh products, cleared by the FDA, are safe and effective and provide significant benefits to patients.” Although the product was cleared by the FDA, it is labeled as posing a high risk to patients. This conclusion is based on information gathered from patient complaints between 2008 and 2010. This January, the FDA asked Bard (along with 30 other medical manufacturers) to study rates of damage inflicted by vaginal mesh implants.
ABOUT THE AUTHOR: Hecht Kleeger & Damashek
At Hecht Kleeger & Damashek (HKD), we are whole-heartedly dedicated to giving our clients the high-quaulity legal representation they need. If you’ve suffered the adverse side effects of a vaginal mesh implant, we want to help you collect damages for your pain and suffering. Our lawyers are well-versed in the ins and outs of product liability cases and are ready to help you stand up for your legal rights in court.
Copyright Hecht, Kleeger & Damashek, PC
More information about Hecht, Kleeger & Damashek, PC
View all articles published by Hecht, Kleeger & Damashek, PC
Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.
