Preview Newsletter
Ethicon Media Monitoring 11/07/16
-
Mesh Injured Address KY Healthcare Conference
Nov 5, 2016 | Mesh Medical Device Newsdesk
Two vocal mesh-injured women addressed a room full of health professionals at this annual conference with a medical device patient safety focus. -
Transvaginal Mesh Problems in Canada
Nov 4, 2016 | Lawyers And Settlements
By Brenda Craig
Exactly how many women in Canada have had transvaginal mesh implanted to deal with bladder issues or collapsing pelvic organs is not known.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Mesh Injured Address KY Healthcare Conference
Nov 5, 2016 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, November 5, 2016 ~ Two vocal mesh-injured women addressed a room full of health professionals at this annual conference with a medical device patient safety focus.
was called the Conference for Healthcare Transparency and Patient Safety and occurred Friday, November 4 in Lexington, KY. Those in attendance could receive 6.25 hours of Continuing Education Credits.
About 100 doctors, nurses and health care professionals filled the conference room at the Lexington Four-Points Sheraton.
The Goals and Objectives were to describe the problem of adverse events and to develop an appreciation of the importance of a culture of safety and the prevention of adverse events, also known as complications; to identify problems in research integrity and conflicts-of-interest which hampers initiatives; and to discuss medical device patient safety problems.
Janis and Tammy had a lot of experience on the latter.
Both women had been implanted with a polypropylene mesh material to treat incontinence. Both had suffered severe adverse events. Patient advocate, Joleen Chambers of Failed Implant Device Association (FIDA), could not make the conference she let the two women know at the last moment and they enthusiastically took Chamber’s place.
In her address to the room full of professionals, Tammy Jackson of Kentucky said she was implanted with TVT mesh (tension-free vaginal tape) in 2007.
She outlined the complications thousands of women have experienced- mesh erosion, chronic pain from the pelvis down to the feet, bleeding and infections, organ perforation, nerve damage, dyspareunia, vaginal scarring, reoccurring prolapse, and foreign body reaction.
“Its a lot more than you hear in the commercials,” she said.
Jackson used to work in the nursing field, now she is on full disability. She told the attentive crowd there have been 10 deaths in the last two years due to transvaginal mesh, women have lost their jobs, their homes, their husbands and their healthcare.
As many women do, Jackson had to leave the state to have a series of surgeries to attempt to remove her transvaginal mesh. Dr. Sara Daiz from Indiana was her “savior” who got as much of the mesh out as she could, Jackson tells MND.
“Know the risks before you get pelvic or hernia mesh she concluded.”
Tammy was accompanied by her daughter Byonia and husband Byron.
Janis Urban told the crown the foreign body reaction in the body involves inflammation and bacteria.
She was a slender woman all of her life. Now she’s up to 275 pounds and she has experienced what many woman do, a distended abdomen after their mesh implant, which she profiled for the crowd. Her doctor, Dr. Christopher Rooney, a urologist from Akron, Ohio, attempted to remove the TVT Exact, which was implanted in 2011.
The difficulty is these mesh implants are meant to be permanent. A full removal is unlikely, though some of the most experienced doctors have had some success at a mesh excision. Mesh anchors may be another story. Often embedded deep in tissue, many removal surgeons will not attempt to remove the anchors.
“This is toxins in the body. We know something is wrong. Patient engagement where is that?,” asked Urban.
There is no medical device safety in this country, Urban told the crowd. Many may not be aware that medical devices do not go through premarket approval that drugs must pass to ensure safety and efficacy.
Jackson and Urban were the last to speak. The room rose off their chairs and applauded. They appeared to be very thankful to hear first-hand from those very patients who experience the downside of untested medical devices first hand. ###
LEARN MORE:
Facebook Tammy Jackson here.
https://www.facebook.com/tammy.jackson.18062533/videos/1756302254693964/Janis Urban addressing conference.
https://www.facebook.com/janis.urban.7/videos/1424178224278375/Tammy and Janis the night before conference
https://www.facebook.com/janis.urban.7/videos/1423201527709378/Janis Urban – After the conference.
https://www.facebook.com/janis.urban.7/videos/1424553144240883/http://www.meshmedicaldevicenewsdesk.com/mesh-injured-address-ky-healthcare-conference/
-
Transvaginal Mesh Problems in Canada
Nov 4, 2016 | Lawyers And Settlements
By Brenda Craig
Toronto, Ontario Exactly how many women in Canada have had transvaginal mesh implanted to deal with bladder issues or collapsing pelvic organs is not known. Estimates run as high as 60,000 women. What is clear is that there are hundreds of Canadian women who are so unsatisfied with the results that they have filed lawsuits – many of those women have had surgery to remove the mesh.
Attorney Paul Miller took on his first transvaginal mesh case in October of 2011 and currently represents about 180 women in transvaginal mesh lawsuits against Johnson & Johnson and other manufacturers of transvaginal mesh surgery kits. Approximately 50 of those cases although the details of the settlements are not public.
“I’ve learned more about female anatomy than I ever thought I would know,” says Miller and not being glib or insensitive when he says that. “You get a wide range of people. Everyone deals with pain differently. You get people who are in desperate need to people who are trying to carry on with their lives.”
Among those women is 52-year-old Christine Asprey of Winnipeg. In January 2012, Asprey had a mesh procedure to deal with prolapsing pelvic organs and mild urinary incontinence. The weeks and months that followed Asprey began to experience extreme pain. It was so extreme that she had the mesh removed in the United States by an American surgeon.
“The pain was suicidal,” says Asprey. “That is how bad it was. The pain is so unreal. Still today the pain is unreal. I have nerve damage and I have connective tissue damage.”
According to Dr. Roxana Geoffrion, a urogynecologist from the Centre for Pelvic Competence in Vancouver, British Columbia, the number of adverse events from mesh is low in Canada and ranging between 1 and 5 percent depending on the procedure.
However, a number of the types of surgical kits produced prior to 2011 and used in these procedures have been dropped from the market because of issues primarily in the US says Dr. Geoffrion.
Dr. Geoffrion is part of a group currently in the process of updating new guidelines for the use of mesh in Canada.
“With the kits that were taken off the market -- there was just too much mesh used,” says Dr. Geoffrion. “The more mesh you use the more pain and erosion you can have.“The new guidelines are to let people know there have been problems with the kits,” says Dr. Geoffrion. “The way you insert it and the volume of mesh is important. I think if people are involved in doing this type of surgery with mesh it should be evaluated as a part of a research trial – and so people can be really informed.
“There are not enough surgeons in Canada with expertise and the time to deal with the number of women who want the procedure undone. Attorney Miller says a number of his clients, including Christine Asprey, have travelled to the US to have mesh removed. Provincial healthcare systems in Canada, in some cases, where women make an application, have been footing the bill for the surgeries.
“It depends on the circumstances,” says Miller. “I would estimate on average the cost is about $25,000 per patient. When we file complaints on behalf of women with mesh issues we try to claim back the money spent by the healthcare system.”https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/transvaginal-mesh-problems-in-canada-21823.html
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested