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. See the videos below.
It 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. ###
Facebook Tammy Jackson here.
Janis Urban addressing conference.
Tammy and Janis the night before conference
Janis Urban – After the conference.