Preview Newsletter
Ethicon 10/7
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Scottish Gov’t to limit pelvic mesh implants
Oct 6, 2015 | Mass Device
By Fink Densford
The Scottish Government’s safety review group said it will no longer recommend 3 of the 4 pelvic mesh procedures performed routinely in Scottish hospitals for patients with pelvic organ prolapse and stress urinary incontinence. -
Shona Robison ‘sorry’ over mesh implant surgery
Oct 6, 2015 | The Scotsman
By Andrew Whitaker
Labour MSP Neil Findlay asked whether the medical establishment should say sorry to women affected by the procedures, carried out by surgeons to treat pelvic organ prolapse and incontinence in women. -
Health minister apologises to mesh implant victims
Oct 6, 2015 | BBC News
Hundreds of women were left in severe pain by operations to implant a surgical mesh. -
Shona Robison apologises to women who have campaigned against controversial mesh implant surgery
Oct 6, 2015 | Herald Scotland
Health Secretary Shona Robison has apologised to women who have campaigned against controversial mesh implant surgery. -
Shona Robison apologises to mesh implant victims
Oct 7, 2015 | The National
By Janice Burns
Health Minister Shona Robison has apologised to women who were left with severe complications following a procedure to treat prolapse and bladder problems. -
Shona Robison apologises to mesh surgery campaign women
Oct 6, 2015 | The Courier
Ms Robison said the women should not have had to resort to petitioning the Scottish Parliament in order for the issue to be brought to light. -
Shona Robison to respond to mesh impants report
Oct 6, 2015 | The Scotsman
The procedure can be used to treat women suffering from prolapse and bladder problems but an independent review was ordered after women who had been left suffering from painful complications took their case to Holyrood. -
Health secretary to respond to report on mesh implant surgery
Oct 6, 2015 | STV News
By Hugh Macknight
An independent review of the procedure was ordered after women who had been left suffering from painful complications took their case to Holyrood. -
Johnson and Johnson Won First Pelvic Mesh Trial
Oct 6, 2015 | Legal Reader
By Jay W. Belle Isle
Carol Cavness, a patient formerly using J&J’s Prosima pelvic mesh had her day in court this week and it didn’t go well. Cavness claimed that the Gynecare Prosima device manufactured by J&J’s Ethicon subsidiary was the direct cause of her injuries. -
Johnson & Johnson wins 1st Prosima pelvic mesh suit
Oct 6, 2015 | Mass Device
By Brad Perriello
Johnson & Johnson reportedly won the 1st lawsuit to go to trial over its Prosima pelvic mesh implant, after a Texas state jury ruled yesterday that the device was not defectively designed and that J&J subsidiary Ethicon’s risk warnings were adequate. -
Cavness Testimony – A Life Today of Pain
Oct 6, 2015 | Mesh Medical Device News Desk
By Jane Akre
...On Monday, she lost her product liability trial against Ethicon/ J&J. This was the first jury decision for the pelvic mesh maker that faces in excess of 30,000 defective product cases filed over its family of pelvic meshes...
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Scottish Gov’t to limit pelvic mesh implants
Oct 6, 2015 | Mass Device
By Fink Densford
The Scottish Government’s safety review group said it will no longer recommend 3 of the 4 pelvic mesh procedures performed routinely in Scottish hospitals for patients with pelvic organ prolapse and stress urinary incontinence.
The change came after the Scottish Government launched an expert review group to analyze the use of the mesh to treat pelvic organ prolapse. The group came to the conclusion that the devices should not be approved for patients, according to Scottish paper Daily Record and Sunday Mail.
“We’re now confident no other woman will be left unaware of the horrific side-effects of mesh implants, We called for a total ban on mesh products as we believe time will show just how dangerous they are. But we’re happy to support the review recommendations as long as they and our petition points are put in place and actioned before any suspension is lifted,” Hear Our voice women’s advocacy group campaigner Elaine Holmes said, according to the paper.
The paper said that it uncovered that hundreds of women had been “left crippled and in agony,” after undergoing a procedure with the devices, which led to an investigation into the mesh implants.
With the change, doctors will no longer be able to use the implants unless authorized by a multi-disciplinary medical team, the paper said. Doctors were also warned that they must report adverse events or “face possible sanctions,” as victims said their problems had been hidden by doctors.
“Stress urinary incontinence and pelvic organ prolapse are conditions which, while not life threatening, cause considerable distress to many women, with disruption of their normal lives. The hope of a treatment which can reduce that distress and return their lives to normal is understandably sought eagerly,” the report reads. “However no surgery is without complications and a number of women have had both minor and major complications due to the surgery itself and some have found their lives transformed completely for the worse, unable to pursue a normal family, personal and working life.”
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Shona Robison ‘sorry’ over mesh implant surgery
Oct 6, 2015 | The Scotsman
By Andrew Whitaker
Labour MSP Neil Findlay asked whether the medical establishment should say sorry to women affected by the procedures, carried out by surgeons to treat pelvic organ prolapse and incontinence in women.
Mr Findlay, speaking at Holyrood’s public petitions committee, said that the women, who have suffered infections, bleeding and ongoing abdominal pain following the surgery, were not believed while the word of senior medics had been accepted.
However, Ms Robison apologised for the fact that women have had to run a high-profile campaign to have their voices heard just days after an independent review expressed “serious concerns that some women who had adverse events found they were not believed”.
Mr Findlay said: “One of the issues throughout this has been that the medical establishment has had a real willingness to believe those who said that this was a fantastic procedure and product, and a real unwillingness to believe those who said they had problems.
“Do you think someone, and I’m not necessarily saying it’s you, do you think someone should apologise to those women who were not believed?”
Ms Robison said: “I am very happy to apologise to women for them having to basically have the campaign they’ve had to have to bring it to everybody’s attention.
“It should never have taken women having to campaign in this way to shine a light on an issue and as I said in my opening remarks I want to thank them for all that they’ve done.”
The apology was reinforced by Scotland’s chief medical officer Catherine Calderwood, who told the committee: “I would reiterate the apology that the cabinet secretary has said to the women behind me here ... but also to the other women who aren’t here but who have been part of this campaign.”
Elaine Holmes and Olive McIlroy, from the Scottish Mesh Survivors Hear Our Voice group, said the apology had been “most welcome”.
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Health minister apologises to mesh implant victims
Oct 6, 2015 | BBC News
Hundreds of women were left in severe pain by operations to implant a surgical mesh.
They felt their symptoms were dismissed by the medical profession.
Shona Robison said they should not have had to lodge a petition in the Scottish Parliament to have their voices heard.
It also emerged that about 80 women have received the controversial procedure since former Health Secretary Alex Neil requested its suspension in June last year.
An independent review into mesh implant surgery was ordered after women who had been left suffering from painful complications took their case to Holyrood.
Find out what the procedure is, and why it has caused a problem for some patients.
Ms Robison, appearing at the public petitions committee at the Scottish Parliament, said: "I'm happy to apologise to the women for having to basically campaign to bring it to everyone's attention.
"It should never have taken women to have to campaign in this way to shine a light on this issue. I want to thank them for all that they have done. They have left a legacy for other women.
"That is probably cold comfort for the ladies sitting behind me."Image copyrightScottish ParliamentImage captionMembers of the Scottish Mesh Survivors campaign previously gave evidence to the Scottish Parliament
Elaine Holmes and Olive McIlroy of Scottish Mesh Survivors - the group which took the issue to Holyrood - want a public inquiry to be held or independent research to be carried out into the safety of mesh devices.
The committee hearing took place after the publication of an interim report by the Independent Review of Transvaginal Mesh Implants, which happened following the campaign.
Ms Holmes, Ms McIIroy and other women affected by the procedure sat behind those giving evidence to the committee.
Many shook their heads when they heard the practice had continued, and were visibly upset at other moments.'Serious concerns'
Ms Robison's apology came after a question by Labour MSP Neil Findlay.
He said: "One of the issues through this has been that the medical establishment has had a real willingness to believe those who said it was a fantastic procedure and product, and a real unwillingness to believe those who said this caused problems.
"Do you think someone should apologise to those women who were not believed?"
He said there were many in the medical establishment who still did not believe them.
Ms Robison said the women who had undergone the procedure since Mr Neil had called for its suspension last summer had asked for the procedures themselves, in light of all available information.
Ms Robison said: "The numbers of procedures have dropped dramatically.
"There have been very, very few carried out in light of the suspension.
"As I have said in parliament, where the women herself was asking for the procedure because of the distress that her condition was causing and the clinician was prepared to continue in that case, then those are the circumstances where the procedure can go ahead."Better training
Ms Robison conceded there may have been an issue with the "communication of the time" as this may not have been the perception of some people, but the minister was clear this was always an option for women.
Catherine Calderwood, the Scottish government's chief medical officer, said that since the suspension call was made, 76 women had undergone procedures for stress, urinary and incontinence and "less than ten" women had received a mesh for a prolapse.
The interim review called for better training to ensure medical staff were more aware of the complications women could suffer after mesh implant surgery.
The report expressed "serious concerns that some women who had adverse events found they were not believed", adding that this added to their distress and meant they had to wait longer for help.
Ms Robison said the Scottish government accepted all the interim report's recommendations. The full report will be published at a later date.
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Shona Robison apologises to women who have campaigned against controversial mesh implant surgery
Oct 6, 2015 | Herald Scotland
Health Secretary Shona Robison has apologised to women who have campaigned against controversial mesh implant surgery.
Ms Robison said the women should not have had to resort to petitioning the Scottish Parliament in order for the issue to be brought to light.
She told Holyrood's Public Petitions Committee the Scottish Government accepted all of the recommendations of an interim report into the procedure, used to treat women suffering from prolapse and bladder problems.
The independent review of transvaginal mesh implants chaired by Dr Lesley Wilkie has called for better training to be put in place to ensure medical staff are more aware of the severe complications women can suffer after surgery, as well as for better research and data.
The report expressed ''serious concerns that some women who had adverse events found they were not believed'', adding this increased their distress and meant they had to wait longer for help.
A Scottish Government suspension on the use of mesh implants remains in place but MSPs were told that about 76 procedures have since taken place for women who were "fully appraised of the risks"
Elaine Holmes and Olive McIlroy, from the Scottish Mesh Survivors Hear Our Voice group, were joined by dozens of campaigners in the committee room to hear Ms Robison's response to the report.
Labour MSP Neil Findlay said: "One of the issues throughout this has been that the medical establishment has had a real willingness to believe those who said that this was a fantastic procedure and product, and a real unwillingness to believe those who said they had problems.
"Do you think someone, and I'm not necessarily saying it's you, do you think someone should apologise to those women who were not believed?"
Ms Robison said: "I am very happy to apologise to women for them having to basically have the campaign they've had to have to bring it to everybody's attention.
"It should never have taken women having to campaign in this way to shine a light on an issue and as I said in my opening remarks I want to thank them for all that they've done.
"We have moved a long way from what's a kind of paternalistic medical model where 'doctor knows best'. We have moved a long way from that but there's still a long way to go and that is about informed consent."
The apology was reinforced by Scotland's chief medical officer Catherine Calderwood, who told the committee: "These women have been injured by something that the medical profession did, albeit perhaps with the best intentions but not with the best information.
"I would reiterate the apology that the cabinet secretary has said to the women behind me here ... but also to the other women who aren't here but who have been part of this campaign."
Speaking after the committee, Ms Holmes said the apology had been "most welcome".
"I think that it will mean a lot to the women because as you know we haven't always been listened to or believed. That was quite unexpected this morning and I would say the fact that it was reinforced by the chief medical officer was appreciated."
She called for the recommendations in the interim report to be strengthened "so that there is no wriggle room".
Campaigners also urged the medical establishment to follow suit with an apology, singling out the UK regulatory body for medical devices, Medicines and Healthcare products Regulatory Agency (MHRA).
Ms Holmes added: "They can't just keep saying the benefits outweigh the risks, that's not on. We've received apologies now, they've got to step up to the mark."
A Scottish Government-led expert group, which includes members of the Mesh Survivors Group, will examine the interim report's recommendations on improved safeguards and how they could be implemented.
Committee convener Michael McMahon said afterwards: "For those whose lives have been seriously affected by mesh implants, and for many others who may be considering this treatment without understanding its potential risks, we now have an independent review that highlights the importance of the provision of evidence-based, properly-audited medical procedures and ensuring that patients' views are heard and believed - genuine informed consent.
"We have heard from the Cabinet Secretary that the expert group will continue its work. Now it is vital the Scottish Government responds effectively and with a clear timetable of action."
An MHRA spokesman said: "We welcome the publication of the interim report. The MHRA continues to sympathise greatly with women who have suffered complications after surgery.
"We are committed to helping to address the serious concerns that have been raised by some patients and have undertaken a great deal of work to continuously assess findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time.Share article
"What we have seen, and continue to see, is that the greater proportion of the clinical community and patients support the use of these devices in the UK in the treatment of distressing conditions of incontinence and organ prolapse.
"We note that the interim report finds that for the majority of woman, serious complications do not occur and we will continue to work in collaboration with patients, the NHS, professional bodies and international partners to ensure emerging issues are detected and acted upon quickly."
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Shona Robison apologises to mesh implant victims
Oct 7, 2015 | The National
By Janice Burns
Health Minister Shona Robison has apologised to women who were left with severe complications following a procedure to treat prolapse and bladder problems.
Hundreds of women were left in severe pain and some are now in wheelchairs because of the damage caused by operations to implant a surgical mesh.
They felt their symptoms were dismissed by the medical profession and Robison said they should not have had to lodge a petition to have their voices heard.
She told Holyrood’s Public
Petitions Committee that the Scottish Government accepted all of the recommendations of an interim report into the controversial procedure.
The independent review of transvaginal mesh implants chaired by Dr Lesley Wilkie has called for better training to be put in place to ensure medical staff are more aware of the severe complications women can suffer after surgery, as well as for better research and data. The report expressed “serious concerns that some women who had adverse events found they were not believed”, adding this increased their distress and meant they had to wait longer for help.
A Scottish Government suspension on the use of mesh implants remains in place but MSPs were told that about 76 procedures have since taken place for women who were “fully appraised of the risks”.
Elaine Holmes and Olive
McIlroy, from the Scottish Mesh Survivors Hear Our Voice group, were joined by dozens of campaigners in the committee room to hear Robison’s response.
Labour MSP Neil Findlay said: “One of the issues throughout this has been that the medical establishment has had a real willingness to believe those who said that this was a fantastic procedure and product, and a real unwillingness to believe those who said they had problems.
“Do you think someone, and I’m not necessarily saying it’s you, do you think someone should apologise to those women who were not believed?”
Robison said: “I am very happy to apologise to women for them having to basically have the campaign they’ve had to have to bring it to everybody’s attention.
“It should never have taken women having to campaign in this way to shine a light on an issue and as I said in my opening remarks I want to thank them for all that they’ve done.
“We have moved a long way from what’s a kind of paternalistic medical model where ‘doctor knows best’. We have moved a long way from that but there’s still a long way to go and that is about informed consent.”
Scotland’s chief medical officer Catherine Calderwood backed the apology, telling the committee: “These women have been injured by something that the medical profession did, albeit perhaps with the best intentions but not with the best information.
“I would reiterate the apology that the Cabinet Secretary has said to the women behind me here ... but also to the other women who aren’t here but who have been part of this campaign.”
Speaking after the committee, Holmes said the apology had been “most welcome”.
“I think that it will mean a lot to the women because as you know we haven’t always been listened to or believed. That was quite unexpected this morning and I would say the fact that it was reinforced by the chief medical officer was appreciated.”
She called for the recommendations in the interim report to be strengthened “so that there is no wriggle room”.
Campaigners also urged the medical establishment to follow suit with an apology, singling out the UK regulatory body for medical devices, Medicines and Healthcare products Regulatory Agency (MHRA).
Holmes added: “They can’t just keep saying the benefits outweigh the risks, that’s not on. We’ve received apologies now, they’ve got to step up to the mark.”
A Scottish Government-led expert group, which includes members of the Mesh Survivors Group, will examine the interim report’s recommendations on improved safeguards and how they could be implemented.
A former ambulance technician wept when Robison apologised because she felt someone was finally listening. Debbie McGeachy, from Glasgow, loved exercise and used to take part in charity runs. Now the 46-year-old uses a wheelchair and says she is a “broken woman”. Despite losing her dream of being a paramedic, she has campaigned for justice with hundreds of other women.
She said: “There were a lot of tears because this is them finally admitting what they have done. We and the MSPs are concerned that every woman who has had this procedure should be made aware of the possibility of adverse reactions five or 10 years down the line.”
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Shona Robison apologises to mesh surgery campaign women
Oct 6, 2015 | The Courier
Ms Robison said the women should not have had to resort to petitioning the Scottish Parliament in order for the issue to be brought to light.
She told Holyrood's Public Petitions Committee the Scottish Government accepted all of the recommendations of an interim report into the procedure, used to treat women suffering from prolapse and bladder problems.
The independent review of transvaginal mesh implants chaired by Dr Lesley Wilkie has called for better training to be put in place to ensure medical staff are more aware of the severe complications women can suffer after surgery, as well as for better research and data.
The report expressed "serious concerns that some women who had adverse events found they were not believed", adding this increased their distress and meant they had to wait longer for help.
A Scottish Government suspension on the use of mesh implants remains in place but MSPs were told that about 76 procedures have since taken place for women who were "fully appraised of the risks".
Elaine Holmes and Olive McIlroy, from the Scottish Mesh Survivors Hear Our Voice group, were joined by dozens of campaigners in the committee room to hear Ms Robison's response to the report.
Labour MSP Neil Findlay said: "One of the issues throughout this has been that the medical establishment has had a real willingness to believe those who said that this was a fantastic procedure and product, and a real unwillingness to believe those who said they had problems.
"Do you think someone, and I'm not necessarily saying it's you, do you think someone should apologise to those women who were not believed?"
Ms Robison said: "I am very happy to apologise to women for them having to basically have the campaign they've had to have to bring it to everybody's attention.
"It should never have taken women having to campaign in this way to shine a light on an issue and as I said in my opening remarks I want to thank them for all that they've done.
"We have moved a long way from what's a kind of paternalistic medical model where 'doctor knows best'. We have moved a long way from that but there's still a long way to go and that is about informed consent."
The apology was reinforced by Scotland's chief medical officer Catherine Calderwood, who told the committee: "These women have been injured by something that the medical profession did, albeit perhaps with the best intentions but not with the best information.
"I would reiterate the apology that the cabinet secretary has said to the women behind me here ... but also to the other women who aren't here but who have been part of this campaign."
Speaking after the committee, Ms Holmes said the apology had been "most welcome".
"I think that it will mean a lot to the women because as you know we haven't always been listened to or believed. That was quite unexpected this morning and I would say the fact that it was reinforced by the chief medical officer was appreciated."
She called for the recommendations in the interim report to be strengthened "so that there is no wriggle room".
Campaigners also urged the medical establishment to follow suit with an apology, singling out the UK regulatory body for medical devices, Medicines and Healthcare products Regulatory Agency (MHRA).
Ms Holmes added: "They can't just keep saying the benefits outweigh the risks, that's not on. We've received apologies now, they've got to step up to the mark."
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Shona Robison to respond to mesh impants report
Oct 6, 2015 | The Scotsman
The procedure can be used to treat women suffering from prolapse and bladder problems but an independent review was ordered after women who had been left suffering from painful complications took their case to Holyrood.
Both Ms Robison and Dr Lesley Wilkie, chair of the independent review of transvaginal mesh implants, will give evidence to MSPs on the Scottish Parliament’s Public Petitions Committee today.
It comes after an interim report was published last week called for better training to be put in place to ensure medical staff are more aware of the complications women can suffer after mesh implant surgery.
The report expressed ‘’serious concerns that some women who had adverse events found they were not believed’’, adding this added to their distress and meant they had to wait longer for help.
About 11,000 women in Scotland have had the implant procedure but MSPs have been told that as many as one in five implants can go wrong, with the interim report noting mesh implants ‘’carry a risk of complications which in some cases are life-changing and cannot be corrected’’.
The Scottish Government has already suspended the use of mesh implants, with Ms Robison making clear last week that this remains in place.
Elaine Holmes and Olive McIlroy, of Scottish Mesh Survivors, the group which took the issue to Holyrood, want a public inquiry to be held or independent research to be carried out into the safety of mesh devices.
Dr Wilkie said last week the interim report “points the way forward for improving services for women in the treatment of these conditions”.
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Health secretary to respond to report on mesh implant surgery
Oct 6, 2015 | STV News
By Hugh Macknight
An independent review of the procedure was ordered after women who had been left suffering from painful complications took their case to Holyrood.
Mesh implants can be used to treat women suffering from prolapse and bladder problems.
Both Ms Robison and Dr Lesley Wilkie, chairwoman of the independent review of transvaginal mesh implants, will give evidence to MSPs on the Scottish Parliament's Public Petitions committee on Tuesday.
An interim report was published last week which called for better training to be put in place to ensure medical staff are more aware of the complications women can suffer after mesh implant surgery.
The report expressed "serious concerns that some women who had adverse events found they were not believed", adding this added to their distress and meant they had to wait longer for help.
About 11,000 women in Scotland have had the implant procedure but MSPs have been told that as many as one in five implants can go wrong.
The interim report noted that mesh implants "carry a risk of complications which in some cases are life-changing and cannot be corrected".
The Scottish Government has already suspended the use of mesh implants, with Ms Robison making clear last week that this remains in place.
Elaine Holmes and Olive McIlroy, of Scottish Mesh Survivors, the group which took the issue to Holyrood, want a public inquiry to be held or independent research to be carried out into the safety of mesh devices.
Dr Wilkie said last week the interim report "points the way forward for improving services for women in the treatment of these conditions".
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Johnson and Johnson Won First Pelvic Mesh Trial
Oct 6, 2015 | Legal Reader
By Jay W. Belle Isle
Carol Cavness, a patient formerly using J&J’s Prosima pelvic mesh had her day in court this week and it didn’t go well. Cavness claimed that the Gynecare Prosima device manufactured by J&J’s Ethicon subsidiary was the direct cause of her injuries. The mesh was surgically implanted to resolve Cavness’ pelvic organ prolapse. When all was said and done, Johnson and Johnson won first pelvic mesh trial.
Cavness’ suit alleged that the Prosima mesh was not only defectively designed, but that Ethicon’s warnings were not sufficient to describe the risk of using the product. The Texas jury did not find Cavness’ case to be compelling and decided in favor or J&J with a 10-2 vote. Cavness’ suit asked Judge Ken Molberg to grant $9.5M to cover past and future medical expenses, pain & suffering and punitive damages.
An Ethicon spokesperson, Matthew Johnson, issued a statement saying that the jury’s decision “reflects the facts in this case.” He also said that Ethicon’s actions in research and development of the pelvic mesh were appropriate and responsible.
He added, “We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events.”
Apparently not concerned enough to help cover the costs of such adverse events. Granted, we can’t have everyone who ever used any product suing the manufacturer claiming that, “It gave me a headache!” when, in reality, they’re just out for the money. However, in a case where substantial damage actually has been done, is there no room at the inn for compassion?
Fine, don’t hand Cavness a $9.5M check, but maybe try to help by covering legitimate expenses to have your product removed/corrected? I know, I know… We’re talking about a major medical device manufacturer and product liability law, what’s with all the compassion crap?
Chalk it up to the bliss from having had a great massage this afternoon.
Sadly, Cavness isn’t feeling any bliss this week and that’s a shame. As this case becomes precedent, it’s quite likely that many other plaintiffs won’t be feeling blissful, either.
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Johnson & Johnson wins 1st Prosima pelvic mesh suit
Oct 6, 2015 | Mass Device
By Brad Perriello
Johnson & Johnson (NYSE:JNJ) reportedly won the 1st lawsuit to go to trial over its Prosima pelvic mesh implant, after a Texas state jury ruled yesterday that the device was not defectively designed and that J&J subsidiary Ethicon’s risk warnings were adequate.
The Dallas County District Court jury’s 10-2 verdict rejected claims by plaintiff Carol Cavness that Ethicon’s Gynecare Prosima device, implanted to treat her pelvic organ prolapse, caused her injuries, according to Court TV News, HarrisMartin Publishing and Law360.
Cavness had asked Judge Ken Molberg to award $9.5 million for past and future medical expenses and pain & suffering, and an unspecified amount of punitive damages.
Ethicon spokesman Matthew Johnson said in a statement that the jury’s decision “reflects the facts in this case” and that Ethicon acted appropriately and responsibly in the research, development and marketing of the Prosima mesh, Courtroom View Network reported.
“We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events,” Johnson told the website.
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Cavness Testimony – A Life Today of Pain
Oct 6, 2015 | Mesh Medical Device News Desk
By Jane Akre
Carol Cavness did testify to the jury in her trial on the afternoon of September 28th. Previously Mesh News Desk had reported she appeared by voice only.
On Monday, she lost her product liability trial against Ethicon/ J&J. This was the first jury decision for the pelvic mesh maker that faces in excess of 30,000 defective product cases filed over its family of pelvic meshes.
The Plaintiffs may have the option to appeal the verdict but vow this case is not yet over.
Here is an excerpt from her testimony from the witness chair before the jury rendered its decision.
She is short, with short spiky hair wearing a dark grey suit. She is obviously nervous. Plaintiff Carol Cavness lives in Greenville, Texas where she recently moved after her divorce. She and Graham were married 15 years.
For almost 24 years she has worked as an airline mechanic at L-3 Communications. She started as a trainee and then advanced through the system to become the highest level, an A mechanic.
Attorney Bill Blankenship for the Plaintiff questioned the Plaintiff. His questions are leading because she is brief and hesitant in her delivery.
In April 2012, Ms. Cavness experienced pelvic organ prolapse as she lifted a heavy concrete pot out of the trunk of her car. She told jurors she experienced a sharp “ouch” pain. She went to work the next day then on Saturday, also at work, she kept going to the rest room. One time she felt something coming out of her body. She has an inspection mirror and saw something pink coming out of her vagina. Her female supervisor told her to to the emergency room.
Cavness said she felt a lot of pressure. It was uncomfortable while she was talking. On cross- the Defense would try to describe that as intense pain.
Ms Cavness speaks in a halting way. She is very nervous. The ER doctor told her bladder was falling out of her vagina. But days later visiting Dr. Kowalczyk she was told it was her colon descending in her body. ” I remember her saying she could fix that,” Ms. Cavness said of Dr. K.
Surgery was performed April 24, 2012 and Dr. Kowalczyk implanted a Prosima pelvic mesh made by Ethicon. She also did a native tissue repair at the same time. After surgery she had typical surgery pain but after six or seven weeks, Ms Cavness said she experienced a different kind of pain – sharp stabbing pain.
Q: Had you ever had that type of pain before? No.
Since Dr. Kowalczyk didn’t see anything wrong and she didn’t understand what was causing the pain, she sent her patient to pain management. Ms Cavness sought another surgeon. Dr. Carley gave her steroids but they didn’t help. He told her what he thought was causing the pain. He said he thought it was the mesh and Dr. Carley recommended it come out. He did surgery to try and take mesh out but Dr. Carley said he couldn’t remove it all because it was embedded in tissue and muscles. He retrieved about 65% of the mesh. It did not relieve that pain.
She had a lot of urinary tract infections and had leakage of urine. She had discharge and odor and Ms. Cavness winces when she says that. How many UTI’s since the mesh? About ten of them and she was hospitalized 3 times as a result. Dr. Carley did a second surgery to try and remove the rest of the mesh but was unsuccessful. The pain continued. Then a visit to a new doctor, Dr. Phillippe Zimmern of Dallas.
Even though she is not computer savvy, Ms. Cavness found Dr. Zimmern, a well known mesh removal doctor. “I wanted this pain to stop, I wanted the mesh out,” she said emphatically. Dr. Zimmern saw the mesh and performed removal surgery in December 2014. But the surgery was very brief. By the time her family went to the cafeteria, they were paged. She was coming out of surgery. Dr. Zimmern did not remove any mesh.
“I was devastated because I knew the pain wouldn’t stop.”
Q: “Do you continue to have vaginal pain today?”
“Yes.
Q: The same type you told us about earlier, the stabbing cutting pain you described?
Every day.
Ms Cavness is involved with pelvic therapy at UT Southwestern where a therapist massages pelvic muscles and tissues. Is it painful? She wipes her eyes with a tissue and answers yes.
What followed was a series of questions by Mr. Blankenship about injuries on the job. Yes, there had been many, shoulder surgery, elbow, ankle surgery. She also took time off to care for her husband after he was burned. She was always able to return to the same level of performance as before.
Today, to make accommodations at work, her co-workers help her and she is transferred to phase 4 interior finishing where she doesn’t have to do a lot of heavy lifting or crawl into cells. “I just cant do the things I used to do,” she said. That includes climbing on ladders and shooting rivets into a bucket bar.
She is prevented from taking hydrocodone on the job so instead she takes ibuprofen and Aleve. Work now leaves her in pain and exhausted. “I love my job” she said more than once and is afraid of losing it, especially at her age of 60. Ms. Cavness frequently squints like the light is too strong, like she is in pain.
Before the mesh was implanted what did you enjoy? I enjoyed life, everything I did a lot of house remodeling landscaping, do it yourselfer, I did everything with the grandkids, swimming, fishing, biking, playing games.
Are you able to remodel around the house now, she was asked. No she is not.
Q: “What do you enjoy now in your spare time?
“I don’t much of anything. I’m with my daughter and her family. We watch movies.”
As far as her husband, Ms. Cavness said there was no affection, closeness, and the couple stopped doing things together like gardening, family get-togethers, barbecuing, fishing and hunting. Her chin quivers. She appears to be holding back tears.
How has the pain effected how you feel about yourself, Mr. Blankenship asks.
“I’m sad, I’m depressed I don’t feel like a woman anymore,” she said.
Your ability to eat and sleep? Your relationship with your family, is it all affected?
“I’m not active with them anymore I don’t want to be around them and show my weakness, things like that,” she says wiping her eyes.
Q: “Carol why do you blame J&J and Ethicon for this?
“Because they made a bad product that’s inside of me.” She is holding back tears now.
Q: “And are you asking this jury for punitive damages to punish J&J?”
“Yes, so no other woman has to go through this.”
For the Defense, J&J and Ethicon, attorney Kat Gallagher jumps in. She asks about the day of the initial prolapse and asked if Ms. Cavness had described her pain as a 7 out of 10. I was having pressure, she said correcting her.
Ms. Cavness saw no brochures or videos of the Prosima before agreeing to an implant, and she didn’t seek a second opinion.
Gallagher then went through the litany of on-the-job injuries and a previous hysterectomy in 1985 though the abdomen. She had back pain had taken her out of work for awhile but it got better. And didn’t Dr. Carley recommend physical therapy? Yes, she said but she was afraid of losing her job and didn’t go. Did he also recommend psychiatric therapy to help with the pain? “I don’t remember that.” said Ms. Cavness.
Gallagher then suggested Ms. Cavness and her husband had marital problems before the Prosima and pointed to her deposition, page 31. She also asked how much she smokes (half a pack a day) and asked if she had been a smoker since high school (yes).
Q: “They warned you smoking could hurt your recovery?”
A: “I didn’t smoke a lot during my recovery.”
Q: “You smoke today?”
A: “Yes.”
On a final redirect, Bill Blankenship established that Mr. and Mrs Cavness lived together as husband and wife until December 2014 when they divorced. Her husband had accompanied her to all of her procedures and surgeries. “We had our ups and downs but we worked them out,” she said. She filed for divorce. she didn’t want to be around her husband with the unpleasantness of UTI’s and other mesh complications.
Her face tightens and she softly cries.
Q:”Are there times you were confused in your deposition?” “Yes.”
Q: “Were you and Graham considering divorce before April 2012?”
“Never. I still loved him and I still do today,” she cries and wipes her eyes.
Q: “Are you worried about the future? About losing your job?”
“Yes, because there’s restrictions there if I can’t do my job, I can’t work there. I’m too old to do anything else.”
She’s crying now. Kat Gallagher concludes her questioning and Ms. Cavness leaves the witness stand.
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