Curtice couple begins organization for women injured from faulty medical device.
A hotly debated subject in congress and the FDA, is proving to be a concern for Americans as medical devices slip through loopholes and into Americans injuring and destroying lives. The FDA’s 510(k) clearing process is presently under scrutiny by several organizations including the Institute of Medicine.
At the request of the FDA, the highly respected Institute of Medicine (IOM) independent 22 month study revealed that, in their opinion the 510k is flawed and should be “scrapped altogether and start anew”. However, many in the senate believed that the flawed, lethal process should remain so that “the medical device industry can continue to create jobs, develop innovative products, and maintain patient safety” and ‘the elimination of the 510(k) process could be very harmful to innovation”.(1)
A Curtice, Ohio couple, David and Teresa Sawyer continue their outcry against the faulty 510(k) process, and hopes to be heard so that medical devices passed through the FDA’s clearance will get a second look for safety. At present time they are working with Marcy Kapturs office for a meeting with the 9th District representative to discuss ways that Ms. Kaptur can aid sufferers of the TVT medical mesh by standing against the 510K process.
David and Teresa has been in the fight of her life since a medical device, the TVT surgical mesh was implanted in Teresa, over a year ago. The device was implanted into her to relieve symptoms of a Stress Urinary Incontinence. “After having 2 rather large babies and a weight loss of almost 100 pounds my pelvic floor muscles just were not what they needed to be.” says Teresa. Within a few weeks of the implantation, the TVT mesh began eroding through her vaginal walls and making fatally sick.
“My wife is like thousands of women worldwide that are falling prey to the dangers of TVT surgical mesh, mainly because they are not properly warned of the risks involved by the doctors putting them in”.
Mr, Sawyer had begun doing extensive research for over a year on the TVT mesh to try to understand how or what he could do to help his wife recover from the devices malfunction. As his research continued he learned about the 510(K) clearing process set up by the FDA, specifically for medical devices. He quickly learned that the process was flawed as well as the product in his wife’s body.
A loophole in the 510(K) allows medical devices slip through the process with absolutely no human testing! The policy is if a predicate device is cleared than any other products similar to the original can be passed through and deemed safe. Manufacturers of devices do not have to prove that their product works, is safe or cures or heals what it is made for.
The shocker with the TVT device, the predicate device that was used to allow passing of later TVTs was recalled in 1996. Boston Scientific’s TVT’s was recalled soon after its release being deemed unsafe, after numerous complaints by consumers.
Leaving the question why is a product that is known to be unsafe be left on the market?
David has made several outcry’s about this injustice “it is morally wrong to put a device into a person that does not have any form of testing” Said David. “It is injuring women worldwide and nobody is listening to us to get it recalled”. “I love dogs, but it took only 3 dogs for a recall on dog food, a recorded 17 women have died from the TVT surgical mesh and it is still on the market.”
One representative of Massachusetts has heard the outcry from a lady injured by the TVT, Congressman Ed Markey spoke out in March about the 510(K) process calling it the “510Pray” says Markey ““The 510(k) process should really be called ‘510 pray’ since patients should hope and pray that the medical device implanted in them won’t cause serious harm.” (2)
“This is a scandal that is bigger than the breast implant scandal” says Sawyer “and though people are seeing these ambulance chasing lawyers put commercials on for the sufferers of TVT, there is nowhere for these hurt women to run to for education or help, not even a support group”
“We have seen our lives so damaged from this device that it was a call to duty to help other women in our situation” says David.
The Sawyer’s lost almost everything due to Teresa’s potential fatal TVT implant. “We had to sell almost all of our belongings to pay for everyday expenses, my wife was so ill that she could not take care of her daily needs and I had to be there for her.” It took a toll on David’s handyman business as “it is impossible to go to a client’s house tear up their bathroom for a remodel then have to walk away to get Teresa to a doctor, emergency room or surgery” says Sawyer, “and we are not alone, thousands of women are losing their jobs, insurance, their home and even their spouses because of the injuries sustained by the TVT mesh and nobody is speaking out for them!”
David and Teresa are being proactive for the sufferers of the faulty TVT device, the development of a nonprofit group TVT-NO! Meshie Survival Foundation is in the works to help women become more educated on the risks of TVT and help them financially, as they begin the removal process. “The TVT device is put in permanently so taking it out is very risky. However, the benefits of taking this out is worth the risks for most women, if under the right doctor’s care”.
At this time we have only 1 doctor in the world at UCLA , Schlomo Raz, M.D, that can take all of the mesh out and save these women’s lives. Says Sawyer “while women wait to get the TVT out, the sharp and toxic mesh rips at the tissue and organs of the woman, it is also very toxic as the mesh decays in the body, causing an uproar of the immune system and is known to cause autoimmune disorders that worsens the pain that the women are going through.”
Mesh Erosion through the urethra, vaginal wall, bowel and bladder
Constant Urinary Tract Infections
Constant vaginal infections
Deep tissue infections
Du novo urgency and voiding dysfunction
Pain in buttocks and thighs
Swelling in the stomach
Difficult and painful defecation/buttock pain sitting
Allergies reaction to the mesh
Obturator Nerve Damage
Shrinkage of the vagina due to scar tissue caused by mesh removal
Injury to lilac vessel’s
Perforation of the Bowl and Bladder
The Sawyer couple is determined to make a change for other women, “the use of medical devices put on the market that are not tested and proven safe and effective is no different than what the Nazi’s did to people” states Teresa ” The FDA’s 510(K) process has to change”.
For more information on the Sawyer’s potential nonprofit group can be found at TVTNO.ORG.