Patients left in dark after medical recall
Thousands of patients affected
-WPRI News
11/13/2009 - Thousands of patients are affected by a hernia patch recall , but some of those patients say they were never told about the potential danger.
Diane Conetta of Cranston is one of those patients.
"What frustrates me the most is that I wasn't even told. Nobody notified me," Conetta said.
Conetta had a hernia patch implanted during surgery in 2005.
Two years later, the manufacturer, Davol Incorporated, recalled some Kugel Mesh Patches after receiving reports the plastic ring inside the patch can break.
According to the FDA recall notice , "This can lead to bowel perforations" and other serious injuries.
The Target 12 Investigators learned that Davol started recalling larger versions of this patch as early as 2005. Target 12 also uncovered a letter sent by Davol to chiefs of surgery dated March 2006.
In it, Davol said it had received reports of patient injury including "1 reported death".
Conetta said she didn't know any of this.
Reporter: "Did you get a notice from the manufacturer?"
Conetta: "No."
Reporter: "Did you get a notice from your surgeon?"
Conetta : " No."
Reporter: "So how did you find out?"
Conetta: "Newspaper."
Conetta said it wasn't until a year after the recall she saw an advertisement from a law firm looking for patients to add to a class action lawsuit against the manufacturer.
Conetta's medical records confirmed she does in fact have the recalled patch. She is now part of that class action suit along with 100 thousand others.
"If I didn't see that newspaper article, I still today, wouldn't know about it," Conetta said.
"There are still people out there right now with recalled products who actually didn't get a notice," Conettas attorney said.
Davol notified its customers about the recall, but its customers only include the hospitals and doctors the products were sold to, not patients.
"And they left the doctors and hospitals on their own to find out who had these patches and go through the process, but many doctors weren't aware of the process, many didn't actually know the recall had occurred."
We asked the Food and Drug Administration whose responsibility is it to inform patients of a recalled medical device.
"The primary responsibility falls on the manufacturer. They're the producer of the device in question," said Joe Raulinaitis, U.S. FDA Spokesperson.
Raulinaitis says it's up to the manufacturer to let hospitals and doctors know and they pass the news on to patients.
We asked the FDA who makes sure this protocol is followed.
"We expect them to do the right thing, and do the proper notification, and we will do the audit checks depending on the level of the recall," he said.
Not reassuring for patients like Conetta who doesn't know from day to day whether the recalled product in her body is a danger within.
Reporter: "Are you scared?"
Conetta: "Yes, I'm very scared. I am very scared."
According to Davol, removing the recalled hernia patch may pose an even bigger health threat.
The company spokesperson said they rely on hospitals and surgeons to get the word out on recalls, because Davol does not have access to patient records.
In Conetta's case, Rhode Island Hospital admits it neglected to inform Conetta's surgeon of the recall.
The hospital says it is now investigating how that happened and how many other patients may be left in the dark.
If you or a loved one have been injured as a result of a defective hernia repair patch or a recalled hernia repair patch you may be entitled to compensation. Contact the Bard Composix Kugel Hernia Patch attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the repair patch, a possible Hernia Patch class action lawsuit, or any other type of Bard Composix Kugel Hernia Patch litigation.
