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Ethicon Media Monitoring 9/6/2017
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Philly Jurors Start Work As 6th Pelvic Mesh Trial Wraps
Sep 5, 2017 | Law 360
By Dan Packel
A Philadelphia jury on Tuesday began deliberating whether Johnson & Johnson is liable for a Pennsylvania woman’s incontinence and damaged urethra, in the latest case to go to a jury in the city’s mass tort program for pelvic mesh implants. -
Senate inquiry hears from pelvic mesh implant patients
Sep 6, 2017 | ABC Online
Australian women who have undergone a pelvic mesh implant have been telling a Senate inquiry about the debilitating complications they say they have suffered as a result of the devices. -
Arkansas Woman Suffers Severe Adverse Reaction from Physiomesh
Sep 5, 2017 | The Legal Examiner
By Roopal Luhana
On July 31, 2017, an Arkansas woman filed a Physiomesh lawsuit against manufacturers Ethicon and parent company Johnson & Johnson (J&J). The case was filed in the Eastern District of Arkansas, but transferred to the Northern District of Georgia where there is a coordinated Multi-District Litigation (MDL). -
Dr. Bendavid Answers Hernia Questions
Sep 5, 2017 | Mesh Medical Device Newsdesk
Dr. Robert Bendavid is a leading hernia surgeon with Shouldice Clinic in Toronto, Canada. He also believes in non-mesh repairs for hernia whenever possible and Shouldice does not use mesh in its hernia repairs.
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Philly Jurors Start Work As 6th Pelvic Mesh Trial Wraps
Sep 5, 2017 | Law 360
By Dan Packel
Law360, Philadelphia (September 5, 2017, 5:29 PM EDT) -- A Philadelphia jury on Tuesday began deliberating whether Johnson & Johnson is liable for a Pennsylvania woman’s incontinence and damaged urethra, in the latest case to go to a jury in the city’s mass tort program for pelvic mesh implants.
Kline & Specter PC attorney Kila Baldwin urged the jury to send a strong message to J&J’s top brass by granting plaintiff Ella Ebaugh a hefty amount in punitive damages. She highlighted the scope of Ebaugh’s ailments that resulted from two implants of mesh products made by subsidiary Ethicon Inc.
“Elsa Ebaugh did not deserve to be irreparably harmed by them, chained to a bathroom, in constant pain, humiliated by this condition,” Baldwin said. “You need to make an award to deter them from ever hurting a woman like this again.”
The 12-person jury, composed of seven women and five men, has heard testimony for the last four weeks. Five pelvic mesh cases have already been tried in Philadelphia, and J&J has lost all but one of them. The company faces a total of nearly $50 million in damages.
Ebaugh’s case focuses on two Ethicon mesh products — the TVT- Secur, which is no longer on the market, and the company’s “standard” TVT product, which is still being sold.
Ebaugh was implanted with a so-called TVT-Secur mesh device in May 2007 to treat symptoms of stress urinary incontinence and ultimately received a second implant of TVT in the summer after her condition did not improve.
After reporting to her doctor in 2011 that she was having sudden urges to urinate and significant pelvic pain, it was discovered that the mesh had eroded into her urethra. Ebaugh ultimately received three separate surgeries over the course of five years to remove the mesh.
Baldwin told jurors that these removal efforts had “mutilated” Ebaugh’s urethra, leaving her without little control of her urination. Baldwin produced a four-page list written by the 51-year old woman that listed ailments and consequences of her surgeries including intrinsic sphincter deficiency, cystitis, daily antibiotic usage and depression.
“The joy has been sucked from her life,” Baldwin said. “She can’t even make love to her husband.”
Baldwin emphasized that the risks of both products outweighed the benefits, and she suggested that while J&J was worth more than $73 billion, the company was too cheap to pay for proper studies before releasing TVT-Secur in 2006.
She returned to that figure at the end of her 75-minute closing as she pushed the jurors to “pick a foreperson with loud voice so that the walls will shake with justice,” as Ebaugh sobbed in the front row of the gallery.
Kat Gallagher of Beck Redden LLP responded that TVT, also known as a polypropene urethral sling, was the “gold standard” of treatments for stress urinary incontinence. She sought to discredit Ebaugh’s two expert witnesses by noting that they were among just 1 percent of urinary gynecologists who do not use mesh implants to treat the condition.
She noted that of the four treating physicians that Ebaugh saw, one is retired and the remaining three still use TVT.
“They think it’s the gold standard,” Gallagher said. “All of them think the benefits outweigh the risks.”
Ebaugh is represented by Kila Baldwin of Kline & Specter PC.
Ethicon is represented by W. Curt Webb and Kat Gallagher of Beck Redden LLP.
The case is Ella Ebaugh et al. v. Ethicon Inc. et al., case number 130700866, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Pamela Wilkinson.https://www.law360.com/lifesciences/articles/960448/philly-jurors-start-work-as-6th-pelvic-mesh-trial-wraps
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Senate inquiry hears from pelvic mesh implant patients
Sep 6, 2017 | ABC Online
Australian women who have undergone a pelvic mesh implant have been telling a Senate inquiry about the debilitating complications they say they have suffered as a result of the devices.
For years, doctors have been implanting the devices as a treatment for a range of complaints affecting women — including incontinence and pelvic prolapse.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists maintains for the majority of women — pelvic mesh implants are safe and cause no problems.
But a growing number of women say the implants have caused excruciating pain and even permanently damaged their body.Supporting Information
RN Breakfast contacted the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
They have declined a request for a live interview but have provided us with this statement:
"About the procedure to remove pelvic mesh, the college says: RANZCOG is unable to recommend any particular doctor for any procedure whether that be in obstetrics or gynaecology. We have nominated a number of units in Australia and New Zealand which can perform mesh removal. These units are accredited Urogynaecology training units with a multi-disciplinary team"
"Data from peer-reviewed journals demonstrate that partial mesh removal is often appropriate and in the majority of cases result in symptom resolution"
http://www.abc.net.au/radionational/programs/breakfast/senate-inquiry-hears-from-pelvic-mesh-implant-patients/8877120
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Arkansas Woman Suffers Severe Adverse Reaction from Physiomesh
Sep 5, 2017 | The Legal Examiner
By Roopal Luhana
Roopal Luhana is an attorney with Chaffin Luhana LLP
On July 31, 2017, an Arkansas woman filed a Physiomesh lawsuit against manufacturers Ethicon and parent company Johnson & Johnson (J&J). The case was filed in the Eastern District of Arkansas, but transferred to the Northern District of Georgia where there is a coordinated Multi-District Litigation (MDL).
The plaintiff claims that after being implanted with the Ethicon Physiomesh, she suffered serious injuries. She seeks in excess of $75,000 in compensatory and punitive damages.Physiomesh Used to Repair Hernia Creates Severe Reaction
According to her complaint, the plaintiff underwent a hernia repair on June 29, 2011. Her surgeon used the Physiomesh device to help support stretched and misplaced tissues. A hernia is an area where tissues, muscles, and organs can protrude, sometimes becoming visible as a “bulge” under the skin. It does not always cause symptoms, but it can create pain and even an intestinal blockage.
Ethicon created and sold Physiomesh for the purpose of repairing ventral hernias, which are hernias that develop in the abdominal area. Physiomesh is a net-like device or “patch” that helps support distended tissues. Surgeons place it over the weakened area, after which it is supposed to incorporate into the body to serve as a permanent solution.
The plaintiff states that after being implanted with the mesh, she suffered from a severe adverse reaction, and had to go undergo additional medical treatments due to complications from the product. She claims that the defendants were negligent in failing to properly test the device before releasing it on the market, and for failing to provide doctors and patients with adequate warnings of the serious risks.Physiomesh 5-Layer System Promotes Migration and Infection
There are currently about 100 cases pending in the Georgia Physiomesh MDL, with all plaintiffs making similar claims. At the center of the problem is how the mesh was made. Physiomesh has a unique 5-layer design that the defendants advertised as being superior to other products on the market, but actually seems to be inferior.
There are two outer layers of “Monocryl” film with two underlying layers of polydioxanone film. At the center is the actual polypropylene mesh. The other layers were supposed to prevent or minimize adhesion and inflammation, and facilitate mesh incorporation into the body.
Instead, plaintiffs claim the multi-layer coating works to prevent fluid escape, which can lead to the formation of seromas (pockets of fluid). These, in turn, result in a breeding ground for bacteria, increasing the risk of infection. The layers also seem to prevent incorporation into the body, resulting in migration and tissue damage, as well as improper healing of the hernia.Ethicon Withdraws Physiomesh from the Market
In May 2016, the defendants issued an urgent field safety notice, warning doctors and hospitals that the Physiomesh product had been associated with higher recurrence and reoperation rates after laparoscopic placement than other similar mesh products. They advised doctors to avoid using the products and to return them to the company.
http://pittsburgh.legalexaminer.com/medical-devices-implants/arkansas-woman-suffers-severe-adverse-reaction-from-physiomesh/
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Dr. Bendavid Answers Hernia Questions
Sep 5, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, May 23, 2017 ~ Dr. Robert Bendavid is a leading hernia surgeon with Shouldice Clinic in Toronto, Canada. He also believes in non-mesh repairs for hernia whenever possible and Shouldice does not use mesh in its hernia repairs.
Shouldice Clinic in Thornhill, Ontario, is the only licensed hospital in the world dedicated to tension-free and natural tissue technique for hernia repair.
Please ask your question and we will attempt to have them answered here. This should not be construed as medical device and please always consult with a hernia mesh expert.Hi Dr. Bendavid, I developed abdominal pain spreading thru my low back, groin, inner thigh, and genitals. It grew worse and great intensity hours before a bowel movement, after trying to open or close a door, sex, menstrual cycle, basically anything increasing abdominal pressure.Due to genital and labia pain, a Dr, said I had pudendal neuralgia bilateral. Interestingly, I discovered by accident weeks ago that putting ice all over my mid to lower abs, reduced all my low back pain and groin pain and most genital pain! I did have lumbar fascia hernia 3 yrs ago where during child labor, fascia tore and my inner fat came thru in lumps size of quarters. I am almost positive that if my lumbar abdominal wall herniated, I may have a couple tears and inguinal or femoral and supra pubic hernia. It’s gotten to where I am disabled, can only wear loose dresses, cannot lift even a gallon of milk, and have ice on my abs hours a day to survive it.
I need the BEST abdominal wall hernia specialist as my scopes all came clean. And no major lumps are felt just a ton of tender Ness left of belly button 3 inche’s on left side and 3 inches over on right w 2 inches down.
Who can help diagnose and treat me near Arizona?? Is Dr. Shirin Towefigh in Beverly Hills someone you recomend?
You seem to know soooo much! Im otherwise young healthy, 31 with a 4 yr old. And 120 lbs 5 ft. It’s crazy how intense the pain is.Anything you can share will be gold. I appreciate it!
Hello Jane (reply for patient),
Needless to say that nothing makes any sense and that I do not see the need of a hernia specialist here. This patient needs a good GP and a referral to a good general surgeon who could carry out some basic tests to rule out any common pathology! I don’t know what a “Lumbar fascia hernia” is.A bilateral “pudendal neuralgia” from what? A childbirth 4 years ago? Since various scopes have been negative, what has been done in a way of ultra sounds, X-Rays, CAT scans, hematology etc. I would certainly be most concerned, given the nature and distribution of pain, of ovarian/uterine, retro-peritoneal, spinal cord or spinal canal pathology. I have seen one such which ended up with the diagnosis of a spinal cord tumor!These are important to rule out. She needs to be investigated thoroughly.Kind regards. RobertDr. Bendavid Answers Hernia Questions
Dr. Robert Bendavid, Shouldice Hospital, Toronto
Mesh Medical Device News Desk, May 23, 2017 ~ Dr. Robert Bendavid is a leading hernia surgeon with Shouldice Clinic in Toronto, Canada. He also believes in non-mesh repairs for hernia whenever possible and Shouldice does not use mesh in its hernia repairs.
Shouldice Clinic in Thornhill, Ontario, is the only licensed hospital in the world dedicated to tension-free and natural tissue technique for hernia repair.
Please ask your question and we will attempt to have them answered here. This should not be construed as medical device and please always consult with a hernia mesh expert.
Hi Dr. Bendavid, I developed abdominal pain spreading thru my low back, groin, inner thigh, and genitals. It grew worse and great intensity hours before a bowel movement, after trying to open or close a door, sex, menstrual cycle, basically anything increasing abdominal pressure.Due to genital and labia pain, a Dr, said I had pudendal neuralgia bilateral. Interestingly, I discovered by accident weeks ago that putting ice all over my mid to lower abs, reduced all my low back pain and groin pain and most genital pain! I did have lumbar fascia hernia 3 yrs ago where during child labor, fascia tore and my inner fat came thru in lumps size of quarters. I am almost positive that if my lumbar abdominal wall herniated, I may have a couple tears and inguinal or femoral and supra pubic hernia. It’s gotten to where I am disabled, can only wear loose dresses, cannot lift even a gallon of milk, and have ice on my abs hours a day to survive it.
I need the BEST abdominal wall hernia specialist as my scopes all came clean. And no major lumps are felt just a ton of tender Ness left of belly button 3 inche’s on left side and 3 inches over on right w 2 inches down.
Who can help diagnose and treat me near Arizona?? Is Dr. Shirin Towefigh in Beverly Hills someone you recomend?
You seem to know soooo much! Im otherwise young healthy, 31 with a 4 yr old. And 120 lbs 5 ft. It’s crazy how intense the pain is.Anything you can share will be gold. I appreciate it!
Hello Jane (reply for patient),
Needless to say that nothing makes any sense and that I do not see the need of a hernia specialist here. This patient needs a good GP and a referral to a good general surgeon who could carry out some basic tests to rule out any common pathology! I don’t know what a “Lumbar fascia hernia” is.A bilateral “pudendal neuralgia” from what? A childbirth 4 years ago? Since various scopes have been negative, what has been done in a way of ultra sounds, X-Rays, CAT scans, hematology etc. I would certainly be most concerned, given the nature and distribution of pain, of ovarian/uterine, retro-peritoneal, spinal cord or spinal canal pathology. I have seen one such which ended up with the diagnosis of a spinal cord tumor!These are important to rule out. She needs to be investigated thoroughly.Kind regards. Robert
Dear Dr. Bendavid:
Hello, I had double and Diep Flap reconstruction in Feb 2017. I’m waiting to have MRI to confirm a hernia. Anytime I bend over, I feel like something is in the way in my lower left abdomen. Very painful. My plastic surgeon has suggested a general surgeon to join him in 2nd phase of reconstruction to repair hernia with mesh. After doing some research I know I don’t want this mesh in my body. Are there any other options to this polypropylene mesh? I read about “tissue-to-tissue” repair, but sounds like it’s only used for certain hernias. And if they can perform this surgery, I’m curious as to what the sutures are made of.I appreciate any help and direction. Thank you, Michele
Dr. Bendavid replies:
Michelle likely had bilateral mastectomies for breast cancer. In the creation of a TRAM (here called a Diep), muscle is taken from the lower part of the abdomen and swung up to the breast area with its blood supply for the reconstruction of an artificial breast. The donor site invariably develops a hernia because a significant portion of the lower abdominal wall is removed.
This is an issue she has to discuss with a general surgeon/plastic surgeon she trusts. I would also recommend she talks to former patients who had the procedure done. I personally feel it is a high price to pay because the defect left behind in the abdominal wall can be large and demand mesh for replacement. Mesh is no longer as benign as we thought it to be originally.The patient must also discuss the issue with her partner since that is where the problem may also lie! I hope the patient finds a balance with the choices.
Kind regards,
Robert
Dear Dr. Bendavid:I had open umbilical hernia surgery two weeks ago..A mesh was used…..I am still having pain in the area, especially when laying on it at night..I also have pain in my groin and what appears to be a very painful urinary tract infection. My surgeon said he used the “new’ mesh and that is not whats causing extra pain.
Dr. Bendavid Replies:
Hello Jane, Re the patient:Two weeks since surgery … not enough time has elapsed to be totally free from pain. Pain in the groin presently should not have any relationship to the previous surgery. Especially if there is suggestion of an infection?! “New mesh”, just like all polypropylene meshes, may be just as much of a problem. Pain will be considered chronic if it lasts more than 3-6 months.
Some recommendations suggest to wait a year. There is no consensus yet since we know that pain can occur years after insertion of the mesh! You may have to obtain a second opinion re: pain but I suggest a little patience yet. RB.
Dr. Bendavid:My granddaughter, age 16, is scheduled to have an umbilical hernia repair at the end of August 2017. I have been told that they will not be using a mesh (at the family’s request) and the surgeon states she will be coapting the wound with sutures. My questions are: Is that the best procedure for this condition? Is the shouldice procedure indicated for an umbilical hernia and if so, are there any hospitals that can offer this procedure in the New Jersey area? Also, what pertinent questions should I be asking the surgeon regarding the surgical technique? I want to be prepared for this as much as possible to avoid any surgical complications that I heard about on the Ralph Nader Radio Show. Please advise. Thank you.
Dr. Bendavid Replies:
What a luxury to have a grandmother who is so protective of her family!
The Shouldice repair is an operation which applies to the groin (inguinal hernias). Umbilical hernias can of course also be done with a pure tissue repair (i.e: without the use of mesh). It will depend on the size of the hernia and it would be unusual at 16 to have one that would require mesh. Even if mesh were necessary, it can be done by an open method which must not enter the peritoneal cavity as is often done laparoscopically! No need for such extensive invasion, especially in a primary umbilical hernia. I would consult with a surgeon you trust near you.
If need me, you can contact me and I will provide you with the name of someone in New York who has worked at Shouldice Hospital. Of course there will always be our hospital in Toronto!
Good luck,
R. Bendavid MD.
Dr. Bendavid:How long should I wait for the pain to go away before I inquire about taking out the mesh?Dr. Bendavid replies:
Two weeks since surgery … not enough time has elapsed to be totally free from pain. Pain in the groin presently should not have any relationship to the previous surgery. Especially if there is suggestion of an infection?! “New mesh”, just like all polypropylene meshes, may be just as much of a problem. Pain will be considered chronic if it lasts more than 3-6 months. Some recommendations suggest to wait a year.
There is no consensus yet since we know that pain can occur years after insertion of the mesh! You may have to obtain a second opinion re: pain but I suggest a little patience yet. RB.Hello Mesh News Desk, Thank you for any information.
I had a left unguinal hernia surgery w. mesh 6 months ago. about 3 months after i did incur a sharp “ripping” pain when i did a heavy awkward lift. surgeon days he doesn’t feel any re-herniation. i have pain only sometimes, hard/heavy work related usually. the area of the hernia feels very different than prior to incident, prior to incident, i felt ‘great’. is there any actual test (ct, x-ray, ?? than can actual know for sure, or even if probable damaged ?? or, did i just “temporarily strain myself” ?? thanks… bill
Dr. Bendavid Replies:It always helps to know what was exactly done in a way of mesh repair and whether the previous surgery was done through an open procedure or laparoscopically. Certainly, following mesh or mesh free repairs, after three months, there should be no limitation of activity. The onset of pain can and does occur on occasions, perhaps associated with heavy activity and may also take place whether mesh was used or not. Nothing is more accurate than a physical examination to confirm absence/presence of a recurrence. An ultra-sound may reveal a recurrence but they can be fraught with false positive/negative results.
It would be wise to simply treat conservatively with heat, massage, anti-inflammatory medication for two-three weeks and avoid the activities which you know give pain. Often, the pain is due to adductor pain or lower rectus insertion strain. More and more, pain is being reported following mesh repairs and may contribute to a “chronic post-herniorrahphy pain syndrome”.
Proper assessment should be made by a hernia specialist. RB.
Hello Dr. Bendavid,Do you remove mesh from women? I have had a total of 3 inguinal hernia repairs, two on my left side (one laparoscopic and one open). I’m in chronic pain and the Dr’s really don’t care, and the ones that do can’t help you. I also had purple plastic found during my second left surgery. The Dr claimed that material could not have been from her. I had Dr Shirin Towfigh review my records (I live in Seattle) and she said that material has to be from the secure straps (or tacs?) used in my first left sided inguinal hernia repair. I believe that and the mesh are causing wierd problems. About a month after each surgery I had weird things happen. For example, I stared having panniculites in my inner thighs. I want to have the mesh removed, but I’m scared to make things even worse. Most Dr’s say mesh causes no problems.
Hi Jane (for your patient):Mesh definitely causes problems. Not in everyone, granted, but when it does it can be quite the challenge. Since you live in Seattle, if you do not know anyone near you who has removed meshes (make sure they do not insert a new one after removing the old one… which often happens and doctors may convince you that the new meshes are lighter and cause no problem. They will if you have had issues with polypropylene) you could consult Dr Kevin Petersen in Las Vegas who removes quite a few and in fact has supplied me with many explants to study.
It is difficult in Canada to do surgery on US patients as the system (State medicine) will not protect surgeons against any suits brought on by US patients. Also, in some states, patients can sue Canadian surgeons and hospitals from their hometowns! It is a conundrum. Your US insurers generally will not cover you for surgery outside the US unless that type of surgery is not done in the US! It would also have to be approved beforehand.
Good luck, R. Bendavid MD.
Dr. Bendavid,
I am a 36 year old woman and was told yesterday in the ER that I have a small inguinal hernia. I was referred to a surgeon because the hernia gives me pain when I carry anything over 5 lbs. I was wondering which type of repair you think someone in my situation should receive?
I am worried because I have a three-year-old who needs her mother and also I very delicate skin. I react with rashes to many creams, wools, and some non gold jewelry. I was told this type of hernia is rare in women, mostly men set it. So, I would like to find an experienced surgeon who has repaired these on Women.
Do you recommend anyone in the Chicago area or in Illinois? I would prefer to just get sutured with no mesh, but I am worried it will. It hold. It so close to my uterus that I am really worried because I had always hoped for one more child. of coarse, I am more worried about my long term health and trying to avoid the horror stories related to mesh.
Please help. Thank you and God Bless you.
Dear Reader,
It is possible that you have a femoral hernia and that is present in 16% of women. The majority of female patients however have an indirect inguinal hernia (70%) which do not need mesh or a direct hernia as in 14% of women. If a femoral or a direct hernia is/are present, they may require mesh but there are safe ways to do it. Laparoscopic surgery does not represent a safe way to do it as it lays indiscriminately mesh against femoral vessels and bladder. An open technique would directly and accurately cover the defect only.
I do not know anyone in the Chicago area in particular. I do in New York. Many US patients consider that surgery in Toronto, when all is said and done, turns out to be cheaper than in the US. You may contact Ms Nancy Law at atnlaw@shouldice.com.
If you decide on New York, you may contact Dr Samer Sbayi atsamersbayi@gmail.com. He did train with us and can be recommended.
Good luck. R. Bendavid MD, FACS.
https://www.meshmedicaldevicenewsdesk.com/dr-bendavid-answers-hernia-questions/
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