Chrissy and Tony Brajcic

Mesh Medical Device News Desk, December 6, 2017 ~ The last years of her life were spent educating and sharing on social media- talking about the life hers had become – one of pain and suffering after a TVT pelvic mesh implant to treat incontinence. 

Christina Lynn Brajcic of Windsor, Ontario had emerged as a leader of Canadian women suffering pelvic mesh complications. Her message was heard internationally and when Canadian television was looking for a representative, Chrissy was chosen.

Always looking well put together and glamorous, she was interviewed and videotaped for a September CTV special on Mesh Misery. (Here).  It reported a 2-15% complication rate following permanent mesh implants, much lower for hernia repair, using the same mesh.

Chrissy’s Post, November 27, 2017.

She launched a Facebook Live with interactive questions to raise awareness, not unlike a Mesh TV show, she said. She wanted to make sure polypropylene (PP) pelvic mesh or hernia mesh also made of PP, was not implanted in anybody else.

Among the last posts of Chrissy the Fab, as she was known, talked about the relentless infections that would return despite treatment with antibiotics.

“Literally couldn’t move talk I was dying, I couldn’t breathe….How did this happen how do I go from infection to heart failure?”

“I’m fighting hard”

“I can’t wait to get back to my old self and get back to being an advocate. I don’t want this to happen to anybody.”

Her last picture appeared on Facebook November 27. She looked pale and weak but held her fist up. She expected two more weeks of antibiotics, “the really strong stuff.”

“But finally beat sepsis again and I’m ready to kick some butt again. This mesh madness has to stop. Thanks for all the love….”

Chrissy lost her fight on November 30th. Her husband Tony says she was a strong fighter right up to the very end.

Ultimately her heart couldn’t continue the fight.

Now her family is planning her memorial. It is scheduled for Friday, Dec. 8th at 2 PM at the Kingdom Hall, 6870 Hawthorne Dr., Windsor, Ontario, N8T 1J9.

Tony asks for privacy during this time and, “Thank you all her friends and family who had given her all the much needed support over the past few year!”

For those who cannot attend, a candlelight memorial is being planned.

 

CHRISSY’S PASSING

Brajcic attorney, Paul Miller

Her attorney Paul Miller tells MND, he is, “Shocked and saddened to hear of her passing. I got the news from a CTV producer… it’s a complete shock”

He will consider amending her complaint filed against Ethicon (Johnson & Johnson), maker of the TVT Exact she received four years ago, but is awaiting the result of an autopsy to determine the cause of death.

Dr. Vladimir Iakovlev, a pathologist from Toronto who has an extensive experience with mesh explants, will share with the Windsor, Ontario coroner his knowledge of which tissues should be preserved to answer any mesh-related questions, now and in the future.

He is not involved directly in this case. See more on the pathologist here. 

The coroner’s office will make its assessment as it routinely does, to determine the immediate cause of death.

Chrissy had recently been hospitalized for a return of sepsis, a bacterial infection which antibiotics could no longer address.

Dr. Vladimir Iakovlev

Dr. Iakovlev tells MND, Information from autopsy alone may determine the immediate cause of death but may not answer all questions. The previous lab tests and history have additional information. For example, if the focus is on chronic infection, it could be urosepsis which can come from recurrent UTI spikes or the cause can be in the kidneys, bladder or other site. 

“It has to be put all together, autopsy findings and previous labs.

Any background conditions, a history of the development of her sepsis and how it’s related to the cause of death will require a thorough analysis of the medical history.

At the time of her death, Chrissy said she was on 15 different drugs and was getting weaker and she experienced right-sided heart weakness. She spent most of her time in bed with her two sons by her side.

Quite a departure from the woman of years earlier. Prior to June 2013, Chrissy was athletic and, according to her videos, she had a six-pack and enjoyed boxing. She was an interior designer and sold Argonne cosmetics on the side. But she lost the ability to work and was unable to participate in athletic, social and household activities with her family.

Chrissy had been undergoing Phage treatment.  Phages are bacterial agents in humans treated with phage therapy. It involves using bacteriophages to target pathogenic bacteria and kill them. Phages are an antibacterial agent that increase in numbers in the presence of bacterial targets.

Phage targeting was largely replaced by the use of antibiotics after World War II but was rediscovered in the 1980s. Phage treatment is an alternative approach when bacterial contamination is increasingly resistant to treatment such as methicillin-resistant staphylococcus aureus (MRSA).

 

THE LAWSUIT

Christina Brajcic filed her lawsuit against Johnson & Johnson Inc, Ethicon Inc and Gynecare Worldwide in Ontario Superior Court of Justice on April 29, 2015. Case No. CV-15-22181.

The complaint seeks general damages in the amount of $346,154 and punitive damages in the amount of $5 million.  Special damages in an amount to be determined.

“The particulars of which will be provided prior to trial.”

She received no informed consent, even after the Health Canada warning? Doc said there was nothing to worry about the bad mesh was off the market.

Attorney Paul Miller, then at Will Davidson, filed the action. It says:

Brajcic lives in Windsor, in the Province of Ontario.  She received a Gynecare Tension Free Vaginal Tape “Exact”, also known as TVT on or about June 25, 2013. It was used to treat her stress urinary incontinence.  Almost immediately she suffered pelvic pain, infections and dyspareunia. She had trouble urinating and suffered ongoing infections.  She continued to take pain medication on an ongoing basis.

“As a result of having the mesh implanted, Christina has experienced significant physical psychological and emotional pain and suffering, and has sustained permanent and debilitating injuries. Furthermore, despite having the procedure, Christina continues to experience problems with incontinence.”

Attempts to remove the mesh have failed.  Christina continues to lose income as she is unable to work.

The complaint outlines what Gynecare/Ethicon knew or should have known:

  • Whether mesh would withstand movement within the pelvis
  • Whether mesh would erode within the body causing pain, suffering and infections
  • Whether mesh erosion could cause nerve and vascular damage
  • Who would have adverse reactions to a foreign body implanted
  • How to completely remove the mesh
  • It was impossible to implant mesh through the vagina without an infection
  • The mesh could cause sexual relations to become extremely painful or impossible
  • How to train specialized surgeons to implant mesh properly
  • There was insufficient scientific information with no studies longer than six months
  • That a study on mesh had to be discontinued because of the rate of complications
  • Post market studies were essential
  • That risks to women were extremely high and the extent of damage mesh could cause
  • That blind insertion of mesh could damage the Plaintiff
  • They knew it was their duty to conduct appropriate testing of the mesh before introducing it for use to the public
  • That their representatives had an obligation to make accurate statements about safety and efficacy but failed to do so
  • That abdominal muscles are stronger and thicker than the tissue of the anterior and posterior vagina
  • That the mesh used on the plaintiff was too inelastic and infeasible for tissue and motion of the pelvis
  • Unpublished studies were proof the mesh should not be implanted in women
  • And that they had an obligation to adequately warn doctors of mesh’s known dangers
  • That they had a continuing obligation to conduct testing and studies and update the medical community

“As a result of the negligence of the Defendants, Christina has suffered and will continue to suffer a loss of enjoyment of life as a result of her injuries.”

And as to punitive damages:

The Plaintiff, Christina, pleads that the Defendants have conducted themselves in a highhanded, wanton and reprehensible manner which warrants the awarding of punitive and/or exemplary damages.”

 

Chrissy outpouring on FAcebook

MEANING IN DEATH

It will be up to Chrissy’s followers to turn grief into meaningful long-term action.  See Monday Mindfulness – in memory of Chrissy.  A petition is underway in her honor to reach the inner chambers of Canadian Parliament.

Her story is being echoed across the internet and there will be wreaths of flowers from her followers at her Friday memorial service.

I don’t want this to happen to anybody” was Chrissy’s true wish. Knowledge, information, education were her goals, and by all accounts, she did it brilliantly, as her many followers attested.

“Chrissy, your passing has given the world greater awareness of mesh destruction. You didn’t die in vain. We will keep fighting. 

A request for comment from Ethicon, (J&J), the maker of her pelvic mesh, had gone unanswered by publishing time.

In the September CTV story on mesh injuries, the company responded:

We empathize with all women suffering from stress urinary incontinence, a condition that can be serious and debilitating. Pelvic mesh devices have helped millions of women suffering from stress urinary incontinence. There are limited treatment choices for women with stress urinary incontinence seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment. Ethicon is confident in the positive impact our pelvic mesh products have had on the vast majority of women who have chosen this treatment option. In addition, the evidence shows that Ethicon acted appropriately and responsibly in the research, development and marketing of its TVT device for the treatment of stress urinary incontinence.”   ###