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Ethicon Media Monitoring 10/4/2018
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Why do we allow the health system to fail women?
Oct 4, 2018 | InDaily
By Olla Kutieleh
Breast implants, implantable contraceptive devices, vaginal mesh used in pelvic floor repair surgeries and bargain-buy cosmetic procedures… These are meant to improve the health and self-esteem of Australian women. -
Mary Dickson Reports on her Depo with J&J
Oct 3, 2018 | Mesh Medical Device News Desk
By Jane Akre
Mary Dickson claims her mother died from the complications of her two Johnson & Johnson mesh implants.
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Why do we allow the health system to fail women?
Oct 4, 2018 | InDaily
By Olla Kutieleh
Breast implants, implantable contraceptive devices, vaginal mesh used in pelvic floor repair surgeries and bargain-buy cosmetic procedures… These are meant to improve the health and self-esteem of Australian women. However, a poorly-regulated industry with little financial or legal consequence for questionable operators means thousands of women’s lives are being destroyed by health problems resulting from faulty medical devices or poorly-skilled surgeons.
When we think about undergoing surgery, there are many factors we take into account. How risky is the surgery? How long will I need off from work? How much will it cost? Who will look after my children while I recover?
However, there are further important questions we rarely think to ask:How experienced is the surgeon?What device will the surgeon be using?What is it made out of? Is it safe?How do I find out what device is inside me if things go wrong?
The truth of the matter is we place so much trust in doctors that we often don’t ask whether the device being used is safe or whether it has been thoroughly tested. Furthermore, we expect that a record is being kept of the brand and serial number of any medical device that is used in case of emergency such as a product recall – much in the same way global car manufacturers can recall faulty parts that may put lives at risk.
Incredibly, and despite multiple cases of medical devices failing and women becoming sick, a compulsory register is still not in place to record the devices being used in each surgery. When these devices fail, women are forced to deal with the consequences alone, which can involve numerous additional corrective surgeries and treatments, significant medical bills and long-lasting pain and suffering.
After assisting thousands of women who have been devastated by substandard medical devices, I can’t express how important it is for any woman considering surgery to ask these questions and get the medical and legal assurances they need.
Australia has received enough warning signs. In 2012, the PIP breast implant scandal was exposed – a case in which I was heavily involved, both in Australia and internationally. The implants were supplied to Australian women for more than 10 years before it was revealed that they contained industrial-grade silicone, not medical grade, and were prone to rupture, leaking the contents into the body.
The measures needed to protect women from further illness, even death, are clear and easy to implement.
The women who received the PIP implants suffered from a variety of serious side effects including severe pain in the chest, arm and back, silicone storing in the lymph nodes and lymphatic system and resulting arm pain, irregular breast shape, the need for multiple further surgeries, as well as other autoimmune type symptoms.
At the time the fault was discovered many did not know, and had no way of finding out, whether they had received PIP breast implants or not. This was because there was no breast implant registry. Women were commonly not given details of the implants at the time of surgery and by the time the defect became known their surgeon may have either retired or destroyed their medical notes.
Many of these women received PIP breast implants following a mastectomy procedure post-breast cancer, or to remedy asymmetrical breasts. The last thing they wanted was to undergo further surgery just to find out what kind of implants they had. Sadly, for many, that was their only option.
A federal Senate inquiry followed the exposure of the PIP scandal. It published a long list of recommendations including the establishment of “an opt-out Breast Implant Registry as a priority”. Despite the priority status this recommendation was given, a compulsory registry – essential in a time of crisis – has still not been established. This means that if another high risk medical device, such as a breast implant, is recalled it will be impossible to know who and how many women have received the implant in Australia. This is unacceptable. However, one would have thought the need for such a resigtry was obvious, noting that, in an orthopaedic setting, there has been a compulsory register for knee and hip implantable devices since 1999.
A compulsory registry is only now being discussed due to the recent research which found a blood cancer risk associated with breast implant surgery. However, the establishment of a registry has been discussed before, to no avail.
Next, we heard of the substandard Johnson and Johnson vaginal mesh implants. Women received this device, via surgical insertion, to repair pelvic floor damage caused by pregnancy, child birth and menopause, and results in embarrassing symptoms such as urinary incontinence. The complications experienced by the thousands of Australian women who received this implant included the mesh or tape eroding into surrounding tissues and organs, infections, incontinence and chronic pain.“You get what you pay for”
Cosmetic surgery today is big business and the barrier to entry has never been lower for those wanting to work in the field. Recently, the ABC’s Four Corners exposed the race to the bottom that is Australia’s cosmetic surgery industry, where doctors who aren’t trained plastic surgeons can perform a wide range of invasive surgical procedures.
A plastic surgeon is a qualified doctor who has undertaken a minimum of five to seven years of additional training, after their medical degree, to perform cosmetic and reconstructive surgeries. On the other hand, a cosmetic surgeon is a doctor who has completed a medical degree but who has not usually undertaken further specific surgical training. Ironically, cosmetic surgery is not even a formally recognised specialty in Australia.
The potential for complications arising from surgery is clear. If the price point seems too good to be true, it is possibly due to the limited qualifications of the doctor performing your surgery. Australian women need to ask themselves if they are willing to pay the price tomorrow for cheap surgery today.
In many instances, Australians are able to travel to parts of Asia, undergo a cosmetic procedure such as a breast enlargement or tummy tuck, spend a week in a luxurious resort by a pool while they recover and come home for less than the cost of the surgery alone here in Australia.
However, while this two-in-one, holiday and cosmetic uplift, sounds great on paper, as always the fine print reveals the serious shortfalls. In this context, the motto ‘you get what you pay for’ could not be more accurate.
Whether at home or abroad, you need to know the qualifications of the surgeon performing your procedure. In addition, when considering surgery overseas you also need to consider the health and safety regulatory framework of the country you are planning to visit for surgery. Australia is known for its high standards, however this is not guaranteed when you travel overseas for treatment and you may be putting yourself at an increased risk of infection and illness.
Issues with female contraceptives continue to mount. In 2014, I was involved in the investigation into the Yaz and Yasmin oral contraceptive pills which reportedly had a higher risk of blood clots and resulted in serious complications for thousands of women.
Furthermore, the Assure contraceptive device, which involves the insertion of metal coils into the fallopian tubes to prevent pregnancy, has recently been found to cause serious side effects. The Therapeutic Goods Administration reported the device causes “changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergy/hypersensitivity, or immune-type reactions. Some of these reports were considered serious and resulted in removal of the device, which involved abdominal surgery”.Questions that can’t be answered
To state the obvious, the one thing these medical devices all have in common is they impact women. So we must ask how are these substandard products making it into our market?
Why are these devices not being thoroughly evaluated before being made available?
What is being done to protect female consumers who have received these devices?
What is being done to reinstate female confidence in the medical device regulatory system?
What compensation is available for these women who receive failed medical devices through no fault of their own?
Who pays for the revision surgery? Who pays for the ongoing medical treatment they now require?
Who covers their income when they are unable to return to work?
Unfortunately, we can’t answer these questions. However, from experience I can say that the women affected by the PIP implants received no subsidy from the government for the further surgery required, no obligation was placed on the surgeon to replace the implants, and there was certainly no avenue in Australia for the women to be compensated for the thousands of dollars they were out of pocket.
Why? Because, under Australian law, a supplier of a high-risk medical devices is not required to have product liability insurance. A breast implant is deemed a high-risk medical device. This leaves trusting women exposed and with no choice but to file their case in France – where the implants were manufactured – in an attempt to recoup some of their losses in a country which seems to have fairer laws in place to protect their female consumers.
Enough is enough. Too many women have suffered from the supply of medical devices that are clearly not suitable and have the potential to be life-threatening. We have seen the benefits of a compulsory implantable device registry for orthopaedics and, logically, this should be required for all implantable devices without any further delay.
We need to ask more of our regulatory bodies to make sure devices undergo more rigorous testing. Furthermore, it should be compulsory for the suppliers of these high-risk medical devices to have insurance so if things do go wrong, innocent women are not left high and dry.
The measures needed to protect women from further illness, even death, are clear and easy to implement. To not do so quickly is nothing short of negligent and heartless. The time to act is now.
https://indaily.com.au/opinion/2018/10/04/why-do-we-allow-the-health-system-to-fail-women/
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Mary Dickson Reports on her Depo with J&J
Oct 3, 2018 | Mesh Medical Device News Desk
By Jane Akre
Mary Dickson claims her mother died from the complications of her two Johnson & Johnson mesh implants. She is taking her case forward Pro Se, without an attorney after she parted ways with two firms. Tuesday, October 2, she was deposed by J&J.
This story is recounted from Mary Dickson and her husband, Rick.
You may never have endured a deposition.
Mary Dickson did Tuesday in her Pro Se (without an attorney) case against Johnson & Johnson. Mary is carrying on her mother’s wrongful death, defective product case against the healthcare giant (2:15-cv-02800 Dickson v. Ethicon, So. District of West Virginia).
Ethicon is the medical device division of Johnson & Johnson (J&J).
Vada Mae Smith died in 2016 from massive infections and organ failure. She had been implanted with two pelvic meshes, both made by J&J to treat her incontinence.
An autopsy finally found one blue mesh deeply embedded in scar tissue and in her bladder. No doctor could ever find the mesh and she went along for years as the Mystery Patient with no one diagnosing what was causing her infections, leg weakness, and pain.
Mary was deposed by Susan Robinson, of Combs & Spann law firm in Charleston, WV. She is a former Assistant United States Attorney and Chief of the White Collar Crime Section, according to her bio on the website.
Husband, Rick says he was very proud of Mary. Without notes she rattled off dates, names, and lot numbers from her keen memory and years of research into her mother’s medical past.
Robinson had printed out all of Mary’s stories on Mesh News Desk. Mary was asked about a conversation in the comments section with Still Standing. Robinson wanted to know if they had ever met. Mary said she’d never met anyone in person, just on the internet.
Please understand the lawyers for mesh makers do watch what you say online.
Mary, Rick and her nephew left their home in Covington, VA to drive to Lewisburg, WV for the 1 pm deposition. The drive took about 35 minutes and at approximately 2,200 feet elevation, the area is still green but getting ready to burst into warm fall foliage.
Also present was a court reporter, a video camera operator, and another woman who said nothing. Mary was told she couldn’t record anything. Her nephew had to wait outside but Rick was allowed to sit in on the deposition.
Tuesday night I asked Mary, “How were you feeling?”
“I was cool a cucumber.”
“I thought you were nervous, I asked.
Mary said she felt exhausted but she wanted to recount the way she felt going into the deposition.
“I think about Sela every day. She was my grandfathers’ mom. Sela Ellen Boon, a Cherokee. She married Ruben Sears, my grandfather’s dad. She sat on the porch and smoked a pipe in the late 1800’s. She lived in Monroe and Summers Co. West Virginia, the southernmost counties of West Virginia and right on the border of several states, Kentucky, Tennessee, and Virginia.
“I talk to them a lot especially at night. I look at the skies and I can feel them looking down at me. Mother too. Mother is the only person ever passed away who showed up in a dream right before (her sister) Ruthie died. Mother was sitting on a hospital bed and had her gown on, feet on the floor.
She took her oxygen off and said, ‘Mary you are doing good.’
“And I woke straight up out of bed. Usually I don’t wake up for nothing, I woke Rick up. I was so excited.
“I felt so sad I had to have Mom cremated. She didn’t get the type of service I wanted to give her. I’m so glad Jesus came and got her.
“After I talked to you the other night, I started breaking down that I couldn’t do it. You thought I’d do really good. When I woke up I was just at peace about it.”
TVT CLEAR
Robinson started out strong.
What if I was to tell you that it was not the TVT-Blue that was put in your mother, Mary says she was told.
Mary replied, “It’s your GyneCare (J&J) stamp on the OR record, that describes the device in my mother.”
How do you have proof, Robinson asked.
I’ve got it in my vehicle, Mary says she replied.
Mary first found her mother’s medical records showing she had been implanted with a TVT (tension-free vaginal tape) in 2001, specifically the TVT Blue System was implanted 70 days before it cleared the FDA for marketing.
Mary made it clear to Robinson, the lot numbers are different.
A TVT-Blue had a lot number of 810041, the TVT clear was 810031. It matched her mother’s OR report. There is one number different between them.
Mary tells MND, “She tried to suggest it was the TVT clear. That was it legal. The TVT Blue she had implanted wasn’t!”
“I stood my ground on the TVT-Blue and I have the Ethicon printout to prove that.”
Mary says, “That’s a big deal. I tried to tell my lawyers that and they wouldn’t listen to me.”
Mary says Robinson’s reaction showed she seemed a bit rattled. Her husband, Rick agrees.
Where did you get this? Robinson reportedly asked about the TVT Blue printout.
Mary answered after Vada’s autopsy, when Dr. Nichols (pathologist) said it was Blue, she started looking at her mother’s device number. She printed out documentation on TVT-Blue.
“You can’t find it anymore on their website, and you can’t pull it off the FDA site.”
Robinson said she needed to take a little break and got on the phone.
When Mary returned from the break, Robinson was still on the phone.
Rick tells MND he was really proud of Mary then.
“She kept her cool and took her time to answer the questions, slowly enough so everybody understood it. She didn’t even use notes. The attorney was a little shook up over the Blue TVT.”
Mary didn’t bring up the autopsy photos that clearly show a blue ribbon of mesh remnant weaving through a portion of Vada’s bladder.
PROCTITIS
Mary had never heard of proctitis but Susan Robinson asked about it, allegedly found in Vada’s colonoscopy report.
Proctitis is an inflammation of the rectum and anus caused by a bacterial or viral infection.
‘Did any doctor ever tell you your mother had proctitis? Did any doctor say mesh caused any of that?’ Robinson reportedly asked Mary.
Did they find any mesh in her colon where the proctitis was?
“I wasn’t aware,” Mary replied, “but I will look it up now.”
MESH NEWS DESK
All of the Mesh News Desk stories referring to Mary Dickson and Vada Mae Smith were printed out “like a little neat book,” and presented to Mary.
Robinson asked what Mary told me (your editor) about her mother’s case and whether I gave her any advice?
Mary says she answered, “No mam, she never gave me advice. She was always a confidant and she encouraged me as she does all mesh victims and families. This was about telling mom’s story. I know that’s what moms’ greatest wish was to help other people because of what she went through. I felt those women deserved to hear my mother’s story. I ran it through my attorney first and got permission.”
How did you communicate? Emails and phone. Do you have those, Robinson inquired.
I have them in my computer Mary said. We might need them, Robinson reportedly replied.
REFERRAL TO HOSPICE
Mary says she also told Ms. Robinson about Dr. Patrick Ryan and her mother’s referral to hospice. Because of the many transfusion and UTI’s, Vada had become resistant to antibiotics; that was the reason for her referral to hospice.
In order to be referred, a patient has to have less than six months to live. Dr. Ryan is a pediatrician and hospitalist. Mary says he did not identify what was killing Vada, all he knew is she was resistant to all antibiotics and didn’t have a long time left to live.
There is no code for a mesh-related injury so he referred Vada to hospice using the code for Parkinson’s disease.
Mary says, “I became very upset I realized mesh in place was not being taken seriously. I wanted the victims to know my mother did suffer and die and her mesh was “in place” but doctors couldn’t find it. They did a CAT scan, MRI, and colonoscopy. We kept thinking it was a bad disease, thought it was cancer, but it wasn’t.’
“Her doctors were at the point where the only thing to check was her small intestine they hadn’t checked for bleeding so we took her to hospital, she swallowed a camera and it came out clear. There was no reason for the bleeding.”
Robinson asked what about her hemorrhoids. Mary answered Vada would bleed and need 4 units of blood. “Hemorrhoids don’t do that!” Mary says she answered.
THE INVESTIGATION
Mary told Robinson she has forwarded her mother’s story onto the U.S. Food and Drug Administration for an investigation. There is no doubt in her mind, the TVT Blue was put in before it was supposed to be put in. Mary insists they broke the law by doing that.
“We went over and over it. She was acting like it was grandfathered in because it’s the same material that’s been used in sutures for years. A stitch as opposed to a mesh is a whole different ballgame.”
Mary also has an appointment to meet with a local prosecutor to explore the wrongful death of her mother.
FEELING TONIGHT
“I bet you’re glad it’s over,” I asked Mary.
“I feel like I just hiked a whole mountain. I didn’t poop my pants. Or faint. I started crying one time, something about mother. That kind of touched my heart. She was always very sad. She had always had a rough life. She (Robinson) gave me a break.”
*PostScript* Mary’s case is still filed in multidistrict litigation in Charleston West Virginia. (2:15-cv-02800 Dickson v. Ethicon. Inc. et al.)
I was not among the thousands of cases dismissed without prejudice among women with mesh in place only. See (PTO #293) . They are given five years to have a revision or removal surgery before they can refile.
Mary says her mother obviously didn’t fit into the group because she had died.
https://www.meshmedicaldevicenewsdesk.com/mary-dickson-reports-on-her-depo-with-jj/
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