March 29, 2013 ~

The experts  suggested that because of the number of POP complications at the time (1,503), that mesh for POP be reclassified from Class II to a Class III or high-risk device. That would require a rigorous premarket review process before mesh manufacturers could sell their product, unlike the pre-market notification that is required now. Many critics suspect POP surgical mesh would never be approved for safety and efficacy if that happened.

But no changes were made and at this time surgical mesh for POP and SUI remains Class II or a low-to-moderate-risk medical device.

The expert panel said it would further consider reclassifying SUI surgical mesh and the FDA promised an update at a later time.

With no notification, the FDA on Wednesday, March 27, updated its information on SUI mesh.

What Is New? SUI Adverse Events Increasing

The agency says it has analyzed adverse event reports, conducted epidemiological research on the safety and effectiveness of surgical mesh for POP and SUI and collaborated with professional societies to understand postmarket performance.

The timing is interesting on the latter point. It should be noted that the FDA update comes one day after the American Urogynecologic Society (AUGS) issued a new policy statement that resists any suggestion mesh use be banned or severely restricted. See it here.

What’s new is the FDA has continued to monitor SUI mesh injuries.

Back in July 2011 (here) when the second Safety Communication was issued by the FDA saying mesh complications were “not rare,” it released the number of adverse events that had come into the FDA at that time.

“From Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.”

The agency continued its review of SUI complications and now reports from January 1, 2008 through September 30, 2011, the FDA received “1,876 reports of complications associated with surgical mesh devices used to repair SUI.”

That represents more than a 36% increase in adverse event reports to the FDA in nine months.

Advocating SUI Mesh

While advising not every woman experiencing SUI will need surgery the FDA appears to endorse sling surgery over non-mesh repairs on the What is Stress Urinary Incontinence? page (here) by saying:

“The use of surgical mesh slings to treat SUI provides a less invasive approach than non-mesh repairs, which require a larger incision in the abdominal wall. The multi-incision sling procedure can be performed using three incisions, in two ways: with one vaginal incision and two lower abdominal incisions, called retropubic; or with one vaginal incision and two groin/thigh incisions, called transobturator. There is also a “mini-sling” procedure that utilizes a shorter piece of surgical mesh, which may be done with only one incision.”

Suggested Patient Questions

The FDA update on SUI includes an extensive list of questions a patient should ask her doctor when she’s considering an incontinence repair (here).  Without seeing the original page it is difficult to assess if this is new information. Questions into the FDA media office about that are pending at this time.

Considerations about Surgical Mesh for SUI

The newly updated FDA page (here) says 250,000 SUI surgeries were performed in 2010, according to the industry, and the FDA says the safety and effectiveness of multi-incision slings is well established among patients who were followed up to one-year.  Mini-slings for SUI safety and effectiveness “have not been adequately demonstrated” and have not been compared to multi-incision slings for safety and effectiveness.

Mesh sling surgeries for SUI have a reported 70-80 percent success rate at one year. A similar rate of success is reported at one year for non-mesh repairs. The FDA page does not say what constitutes “success.” As we’ve learned from testimony in the Linda Gross trial, success is sometimes defined as the correct placement of a pelvic organ and not the quality of a woman’s life after the surgery.

The most common complications coming into the FDA for surgical mesh slings for SUI repair, in descending order of frequency, include:

“pain, mesh erosion through the vagina (also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Many of these complications require additional medical intervention, and sometimes require surgical treatment and/or hospitalization. With the exception of mesh erosion, the above complications can occur following a non-mesh surgical repair for SUI.”

The FDA suggests partial removal may be a remedy.

Recommendations for Health Care Providers

What’s new may be an additional recommendation to health care providers that encourages the surgeon receive specialized training for each SUI mesh placement technique. The American Urogynecologic Society (AUGS) in its policy statement just released also recommends more specific training for doctors.

The FDA also encourages doctors to be fully informed about:

• The likely success of transvaginal SUI surgery compared to a non mesh surgery
• The potential postoperative complications and its effect on the quality of lift
• That  there is limited information about outcomes after one year
• The specific product to be used
• That a mesh sling is a permanent implant
• That SUI surgery using mesh can make any future surgeries more challenging and can “put the patient at risk for additional complications and surgeries.”
• Ensure the patient understands the post-operative risks and potential complications
• Provide the patient with the labeling or brochure

You’ll recall that during the Linda Gross v. Ethicon case, it became clear that there was a “failure to provide adequate warning” to her implant surgeon Dr. Benson by a jury vote of  7-yes and 2-no. That means the surgeon also may not have enough information to provide an adequate “informed consent.”

*Editors Note* Without being able to compare the original FDA pages to this newly updated information it is difficult to determine which represents a departure for the FDA in terms of SUI mesh. MDND requested a comparison to answer that question on Thursday. We’ll update you when that is forthcoming. #

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October 17, 2012 ~ Court cases filed around the country naming six mesh makers currently number 10,000 and are growing, some at a rate of 100 new cases filed a week.

MDND has added up the number of lawsuits pending in federal court consolidated in multidistrict litigation (MDL) as well as those cases filed in New Jersey and in Georgia.

There were 200 lawsuits filed against mesh maker, Ethicon (Johnson & Johnson) alone in federal court since September 30.

Here are the numbers of cases consolidated in the Southern District of West Virginia before the Honorable Judge Joseph Goodwin. This is called multidistrict litigation because consistent court rulings allow the cases to move through the courts with more expediency.

Each case can still be tried individually and will be awarded on its individual merit.

So. District of West Virginia as of October 16, 2012:

American Medical Systems, Inc. (MDL No. 2325),                                              1,887
Boston Scientific Corp. and Ethicon, Inc. (MDL No. 2326),                                1,179
Ethicon, Inc. (MDL No. 2327) and                                                                      1,854
C.R. Bard, Inc. (MDL No. 2187) and                                                                   1,307
Coloplast  (MDL No. 2387)                                                                                      40

In Atlantic City, New Jersey Superior Court before the Honorable Judge Carol Higbee, as of October 16, 2012:

C.R. Bard is facing there have been 312 cases filed against C.R. Bard

Gynecare, a division of Johnson & Johnson has had 1,693 cases filed

In the Middle District of Georgia:

These are cases filed against Mentor concerning its Ob tape. As of October 16, they number 143 cases.

Total for MDL and New Jersey and Georgia= 8,415 lawsuits filed against seven mesh makers for injuries sustained after women were implanted with synthetic mesh and suffered injuries including mesh erosion, perforation of organs, nerve entrapment, pain, disability, and other outcomes.

This number does not include various lawsuits filed by individuals in state courts around the country.

Background

The U.S. Food and Drug Administration outlined the potential for complications in its July 2011 Safety Communication (here)  and stated that these complications are “not rare” [their emphasis] and that,

“it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with PO and it may expose patients to greater risk.”

POP is pelvic organ prolapse while SUI is stress urinary incontinence, two conditions which are treated with synthetic mesh made of polypropylene.  While the FDA has issued this warning about pelvic organ prolapse mesh, it has not come to the same conclusions about SUI mesh, though it is made of the same material and many of the women who have filed lawsuits have similar complaints or injury and disability.

“The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.”

From January 2008 through December 2010, the agency received 2,874 reports of compolications associated with surgical mesh devices used to repair POP and SUI with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. It is predicted these numbers represent anywhere from 1% to 10% of real-life incidents since the FDA database for adverse events is little known and difficult to navigate.

Deb Contestabile

Mesh patient Deb Contestabile recently asked what’s happened to the SUI conclusions by the FDA? (here).  Mesh Medical Device News Desk (MDND) featured the 46-year-old as its most recent Patient Profile (here).

 

Learn More:

FDA Safety Notification, July 2011
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

 

NJ Superior Court/ Judge Carol Higbee NJ – Bard
http://www.judiciary.state.nj.us/mass-tort/pelvicmesh/bard/bard-case.pdf

NJ Superior Court / Gynecare
http://www.judiciary.state.nj.us/mass-tort/pelvicmesh/gynecare/gynecare-case.pdf

 

Middle District of Georgia
https://ecf.gamd.uscourts.gov/cgi-bin/AsccaseDisplay.pl?75532

Southern District of West Virginia/ Bard Cases
http://www.wvsd.uscourts.gov/MDL/avaulta/cases/recordList.cfm

So District West Virginia/ American Medical Systems
http://www.wvsd.uscourts.gov/MDL/amsinc/cases/recordList.cfm

So. District West Virginia/ Boston Scientific
http://www.wvsd.uscourts.gov/MDL/boston/cases/recordList.cfm

So. District of West Virginia/Ethicon
http://www.wvsd.uscourts.gov/MDL/ethicon/cases/recordList.cfm

So. District of West Virginia/ Coloplast
http://www.wvsd.uscourts.gov/MDL/2387/cases/recordList.cfm

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Deb Contestabile

 February 3, 2012.

That was the day that Deb Contestabile says her health took a downturn from which she has still not recovered.

The 46-year-old mother of two boys led a predictable and comfortable life with her husband of almost 22 years who owns a machine shop.

They have busy lives with the two boys in sports and her full-time job as an administrative assistant at the University of Rochester in Rochester, New York. Deb was about to transfer to another department and thought, why not take time first to fix this small, inconvenient problem of incontinence. She believed it would be minor surgery to treat a “somewhat embarrassing problem,” and besides, Deb’s friend had had the same procedure six months earlier and raved about no longer having to wear pads or worry about sneezing.

Deb wanted to start the new job free and clear of the problem and not need to take time off once in her new position.

She went to the same urologist as her friend.

“I had never gone to him before. He was abrupt with zero communication, like he was in a big hurry, he came in and left. I didn’t worry about that because my friend recommended him” she says.

Was she told about complications? In other words, fully informed so she could give her consent to the surgery?

“I didn’t research a lot which is not like me. I normally research and am skeptical, but I thought this was just minor so I didn’t really think too much about it. He gave me a pamphlet which didn’t say much.  He seemed more concerned that my insurance would qualify me to have it.”

The urologist told Deb the time off would depend since everyone is different. The surgery was scheduled for a Friday and she would go home the same day with a catheter which would allow her to empty her bladder through a tube.  She’d come back Saturday to have the catheter removed.

With those assurances, Deb didn’t even take Monday off in preparation for the surgery.

“After the surgery, I found out I shouldn’t be driving for two weeks. The pre-surgery prep at the hospital just seemed like a lot of paperwork, talking about the hospital and where to go. I knew any surgery has risks, but I had no idea how serious mesh complications could be, how common they were, or how difficult they were to fix.”

“I thought, if there was a problem, they’re going to fix it.”

Deb C. and her husband, Kevin

Surgery

So on February 3 of this year, Deb Contestabile had the American Medical Systems, Monarc TOT, transobturator tape (TOT) sling implanted to support the urethra. Using three small incisions, called “minimally invasive” the synthetic polypropylene mesh is pulled into place through two groin incisions, the obturator membrane and around the ischiopubic ramus region.

The procedure is said to be safer than a “blind” needle passage and does not have to pass through the abdominal wall like traditional slings.  AMS has more on the mesh on its website (here).

Transobturator surgery, Miklos and Moore

YouTube has a video of the procedure * Warning very disturbing images (here).

Here is a animation from AMS *Warning disturbing images (here) .

She says it’s been all downhill since.

AFTER SURGERY

“I had problems right away. I felt terrible that night. I was so sore I could hardly move, I was bleeding bad. I called my friend that evening and asked her, ‘Were you like this? I can’t move?”  Then I called the surgeon’s after hours emergency care.  An on-call doctor returned my call and told me I was okay to wait until my appointment the next day to be seen.”

Deb was scheduled to come in Saturday morning to have the catheter removed, but when she got there, the clinic was closed.

“I was hobbling around with my catheter and the clinic was closed! I’m in pain right? There was a gentleman there also waiting and I’m on my cell phone calling the after hours care again, what the heck?”

Eventually a nurse showed up, apologizing profusely. She removed the catheter from Deb and told her, “You’re fine.”  Still, no doctor showed up. Deb was told everybody is different and if the bleeding gets worse, call the doctor.

A friend drove Deb to and from work for a couple of weeks and Deb says she felt the stitches. She was still in a lot of pain and thought “Maybe I’m just taking longer to heal.”  Two weeks after her surgery during the follow up she told the surgeon she could still feel the stitches and was in a lot of pain.

Deb and Cleo

“He didn’t even examine me. I asked him what happened on my appointment the day after my surgery when the office was closed.  He acted as if he didn’t know anything. I was concerned by the amount of   pain and how hard it was to walk but he assured me everybody is different. “Give it time”, he said, and quickly ended the appointment.  I called my friend right after, ‘did he examine you?’  I was dumbfounded. I couldn’t believe it.”

Deb was now hobbling around with pain in the groin, left leg and hip area. It grew worse and worse until she felt her leg giving out.

“I started getting shooting pain in my left groin/leg whenever I walked any distance.  The pain stems from what I now know is my obturator muscle area, and then sort of goes out and down my leg.  That same pain just kept getting worse.  I started limping more and more, and by July it got so bad I was using a cane or a crutch.”

Today she can’t walk without using a crutch and regular pain medication.

At work, Deb attempted to hide the fact she felt sharp pain, but the limp was harder to hide. Thinking she might need to get in better shape she tried to walk during her lunch hour, but this just increased her pain and soon any distance at all was impossible.

A visit to her regular doctor at the end of April yielded no answers. She was told she might have bursitis and given anti-inflammatory medication.  Then, at her second follow-up with the urologist in May she pointed to the area where she was experiencing pain. That couldn’t be linked to the sling surgery, she was told.

But that was not enough of an answer for Deb. This pain didn’t just coincidentally start after her mesh surgery.

ROUND OF DOCTORS

By April Deb found herself on the circuit of doctor visits that so many mesh women experience trying to find out why she felt so bad. She visited the original surgeon in May for her second follow-up, and told him she was limping. By this time the internet had yielded some suggestions she might not be fine and that her sudden onset of symptoms since the mesh surgery might be related.

“He immediately said it’s not from the surgery. ‘Everything we did is over here in the abdomen’ he pointed, ‘you wouldn’t be having pain in the leg or hip area’. I said, ‘yeah, but it hurts right here’, pointing to what I know now is the obturator muscle, and said ‘the pain starts here then shoots out and down my leg’. He still looked me in the eye and said, ‘That’s not related’ and told me I should go to a chiropractor,” Deb says today.

Still, she received no internal exam in fact, the surgeon never examined her after his surgery. Later his notes would say she complained of pain “far away from the incision area” and she had no vaginal pain.

Her primary doctor gave her anti-inflammatory drugs and told her to go to an orthopedic doctor, who said she had a mild hip dysplasia in her left hip. All the pain was from that and not the mesh she was told. She had x-rays, an MRI done, received a cortisone hip injection and was referred to another orthopedic specialist. She was too young for a hip replacement but she might be a candidate for a hip osteotomy where bone is cut to change its alignment before it’s put back in the pelvic area. This is major and rare surgery with a long recovery time. She would have to drive or fly to a special clinic in Boston that specialized in that type of surgery.

“They were more willing to discuss that than mesh removal,” said Deb who still suspected her shooting pain must be mesh-related.

Finally, the first confirmation came from a Rochester area urogynecologist that Deb sought out independently and waited months to see. This doctor suggested her pain could be mesh-related, though she’d never seen that complication before. “You’re the first one,” she was told, as so many mesh-injured women hear. The doctor didn’t blame Deb for wanting it out and told her a partial removal might be possible but a total removal wasn’t possible.

Deb and family

Deb’s online reading told her partial removals often left more women in excruciating pain and in need of additional surgeries.  Research yielded more information. The transobturator tape had been known to pinch the obturator nerve and cause groin and leg pain. She watched a video of surgeons doing a Monarc Sling surgery and saw the kit they used. They take a steel hook through the obturator muscle.

“Once I saw that, I thought how could he look me in the eye and say that is not related?” Deb says. Her next move was to call the clinic of Dr. Shlomo Raz at UCLA, hoping for a cancellation appointment. Regarded as the premier mesh removal doctor in the world who sees hundreds of women every month who fly into the clinic from around the world to have their vaginal mesh removed, Deb kept calling and finally got an opening in August.

His comfortable manner made her feel she made the right decision. The Monarc Sling is known to cause the kind of pain you’re describing, she was told. His exam revealed that part of the mesh was thicker than 1 centimeter so it may have bunched up or was shrinking and jabbing her obturator muscle causing spasms. His opinion was to have the entire sling removed, not a partial removal. She might experience an 80 percent chance of recovery and her incontinence may not come back if the urethra stays in place.  If it does come back, he told her she could come back in a few months and they could make another sling using her own tissue – no mesh.

“He seemed to know exactly what I was talking out,” she told MDND. Finally some good news; the bad news –Dr. Raz is so booked up, he couldn’t operate until January.

Insurance will cover the operation, but not the travel and hotel.

“Every day I wonder how I’m going to make it until January,” Deb says but she adds she is one of the lucky ones, not only to have insurance, but a supportive husband and two kids who can do a lot for themselves.

“I can’t keep up with anything -work, laundry, dinner, anything. The other day my 15-year-old forgot his homework and called me to ask if I could bring it to school. I said, okay. Then, I thought, ‘wait. Is there handicapped parking there? How close?’ I pictured the huge steps up the front of school. I started crying, I can’t even bring my kid his homework.

“My younger son said, “I don’t like you like this.” He wasn’t being mean. I told him I don’t like me like this either. I’ve had a lot of friends look at me funny when we get together and see me with the cane or crutch and say things like, ‘I’m sorry, I can’t get used to seeing you like this. It’s so not you’. My husband’s been a saint through this. I don’t know what I’d do without him.”

WAITING FOR SURGERY

Deb C.

Deb says she is not embarrassed to tell anyone about what she’s experienced and feels like she needs to warn people. Friends are shocked that she is hobbling with the aid of a crutch at age 46. She has joined the online community of Mesh Medical Device News Desk, the same group on Facebook page, TVT No, Medical Mesh Legal Support and other sites, and has talked to hundreds of other women who are suffering, some in silence.

One women has posted a video (here) on YouTube of her travails getting into and out of a car. Deb says that’s how she’s getting.

Deb plans to let all of the doctors who consulted her know what the real cause of her pain was, after her surgery. She wonders if they were entirely unaware of the two Safety Notifications from the U.S. Food and Drug Administration, or if they just didn’t think they applied to her?   The first in 2008 said the thousands of complications such as mesh erosion, perforation of organs, pain and systemic changes. The second mores strongly worded in July 2011, said complications are “not rare” and questioned whether the use of mesh was worth the risk.

While these warnings involve synthetic mesh used for pelvic organ prolapse (POP), the FDA has not issued a similar warning for the same mesh used for incontinence (SUI).

“The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date,” the agency said in July 2011.

So far there has been no update, but an expert panel convened in September of last year seemed to agree that incontinence mesh did not pose the same dangers.  See the FDA July 2011 warning here.

As a result, Deb wonders if this is why she wasn’t fully warned of the risks, and vented her frustration in an article she posted in Facebook as well as MDND called, “Mesh: Definitely risky for POP, but for SUI? Eh? It might be okay still, right?”

Finding a lawyer willing to take a case of SUI mesh injured woman sounds like another hassle to Deb that she’s not sure she wants to take on currently. At the moment, Deb, like other women injured by synthetic mesh used to treat SUI, is not represented.

“Perhaps one of my greatest challenges now is waiting.  My condition only gets worse.  Everything is getting harder and harder, emotionally now, as well as physically. To me, what I’m going through seems like a little personal hell. I’m normally a strong, independent woman. I hate missing my children’s events… not being able to do things like walk my dog. I loved long walks through the woods with my kids and dog but that’s something I haven’t been able to do lately. I hope that my waiting and going to Dr. Raz will save me a lot of time and pain in the future.

“I had this surgery so I could be more active and not have to deal with the minor problem of incontinence, but now I can’t even walk.  Had I known one tenth of what I now know about mesh, I never would have done this.” ##

Patient Summary

Deb C. 46 years old

Mesh: Monarc TOT transobturator tape, American Medical System to treat SUI

Implanted: Feb 3, 2012

Explanted: Not yet, waiting for January 2013 removal surgery, Dr. Shlomo Raz, UCLA

Catheter: yes

Represented: no

File FDA report: yes

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Deb Contestabile

by Deb Contestabile, October 2012

I was reading the FDA alert from July 2011, (yeah, I have strange hobbies lately) and this part gets me.  It says:

“from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP(Pelvic Organ Prolapse) and SUI(Stress Urinary Incontinence), with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.”….

Yet, in spite of those numbers, it goes on to say,

     “The Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.  The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date“.

First of all, isn’t it a “later date” yet?  Where’s this “further communication” about using surgical mesh to repair SUI?  Don’t they already have enough guinea pigs, I mean women, like me, with reported proof of complications from SUI surgeries using mesh??  How can so many doctors still be telling patients that mesh for SUI is ok… and it’s the “other, “bad” mesh” for POP – that is the problem??   Is it because the FDA warnings sort of allow this by not specifically addressing  mesh used for SUI?

Secondly, it’s all so absurd.  Mesh is mesh.  It’s going into the same general area.  If it’s not safe for POP, why in the world would it be safe for SUI???  If there’s no evidence that it “provides any added benefit compared to traditional surgery without mesh” for POP, then WHY would it be better for SUI??  I don’t get that.  Maybe I’m not a genius, and I know I’m not a doctor – but, this just doesn’t make any sense to me.  And, actually, for SUI, often it’s even more of an “elective surgery”…  So, wouldn’t those risks of complications from mesh outweigh the benefits even more for SUI than for POP??

In my case, and I’m sure many other women like me, it wasn’t like I HAD to have surgery for SUI.  I chose to.  I kick myself in the ass for that now, but yeah, I chose to.  No, I did NOT really research it before hand. I didn’t think I needed to.   I just heard it was quick and easy, that it would alleviate the kind of problems most women my age with kids have (SUI). I had a friend who had it done, and I thought – “cool.  sounds easy enough.  I’m going to do that”.  I assumed a doctor wouldn’t put something in me, or perform a surgery that might really harm me, especially for SUI.  I thought it was suppose to be “minor surgery” to fix a minor, somewhat embarrassing, and mostly just inconvenient problem.  To “improve your quality of life”.   It never dawned on me that “they” (you know… “them”… “those guys”… whoever “they” are) would allow a product with such devastatingly high risk complications to be used for a surgery like this?  Especially, without trying all other options first, AND without fully explaining the risks?

Can you imagine if they DID warn people about all the risks?  What it they just really laid it all out for you?  What if they just told the truth about POP AND SUI surgery using mesh and the high risks involved… and just what those complications entail?

I mean, what if a doctor had said to me,

“well, ya know, if this works… Great!  You won’t pee when you sneeze, or when you laugh!  And  you will be able to jump up and down on a trampoline and never have to worry about wearing a pad again!!  =)  YAY!  right??  Right!!  =) ….  And, we really DO think it will work.

BUT, well, just so ya know… if it DOESN’T work…  ummmm……

I should probably warn you that you might never walk normally again, if at all,  aaaaaand you could be in constant severe pain… you also just might get really sick with chronic infections…      but, really,  it’s actually MUCH more likely that it will just erode through your vaginal wall and you won’t be able to have sex…  but before you realize that, your husband or significant other might just have to find that out the hard way.

Did I mention the soft mesh turns into more like a wire screen, with sharp jagged edges, once it hardens in your body?  Yeah, it’s true..  looks like a piece of screen from your window, and, well, it could possibly work it’s way through your vaginal wall.. or into your colon, bladder or other soft tissues…… *shudder*

Of course, we certainly HOPE this doesn’t happen to you…

BUT…..,

….you probably should know that the FDA put out a warning in July 2011 that said complications are NOT rare.  So, yeah… “not rare”…?  What exactly does that mean?  We don’t really know.   “Not rare”.  ?  I know, right?  Vague, but still doesn’t sound good, huh?

And, get this… if you DO have any of these problems?  Well, you might just have to deal with it because we don’t really know a lot about this, and there’s a lot of mixed messages out there.  There’s not really very many doctors that have a lot of experience removing it once it’s in there…  because, you know, it’s not really SUPPOSE to be removed. Personally?  I wouldn’t dream of removing it… so, don’t look at me if there’s a problem!  You see, it literally “meshes” with your tissues and errr… stuff… so, it’s very tricky to remove it once it does that, let me tell you!

Most women who do need it removed because of complications wind up needing to have multiple surgeries to remove it… often resulting in more complications, and often permanent damage.  Terrible, I know…  What’s worse is there are some docs that might even just tell you that you’re crazy and wash their hands of you when they don’t know what to do to “fix” the mesh of a mess you’re in, rather than refer you to an expert who maybe CAN remove it all.  Not me.  I wouldn’t do that, but I hear it happens… but, hey… that “expert”?  well, they are probably no where near where you live anyway…  probably “out of your network”… and also booked solid for months and months… so, good luck getting to see them!  And besides, by then, you may or may not still have a job  or health insurance anyway.  So, yeah.. that sucks even more I guess right?… Yeah.. well…. Sorry to have to tell you all that…  but… well?…

WHEW!!  Do I feel better getting all THAT out in the open!!

Now, back to if it DOES work…

Did I mention you can actually jump up and down on a trampoline again without a wearing a pad!  And SNEEZE or LAUGH without peeing!!  Won’t THAT be cool?! =)  You BET it will be!   So!?!  Are ya ready to do this?  Let’s do this!!”

Can you imagine?   Yes, I wrote this tongue in cheek… I have to amuse myself with sarcasm and humor.  I can only WISH my doctor was cool enough to have said this to me.  If he had, I sure as hell would NOT have had the surgery.  Call me chicken… but, I’m pretty sure I would have ran like hell.  Which reminds me, I really MISS being able to run like hell!  Anyway, unfortunately no…  no one mentioned all these serious “not rare”, terrible risky, complications to me beforehand! Granted, no one mentioned the trampoline either… but, I thought it.. and, well, you get the gist.

Now, maybe, “they” didn’t need to “warn” me, because the FDA specifically talks about POP and not SUI mesh surgeries?  Maybe, they didn’t even know about the FDA warnings?  I don’t know. All I do know is that the more I learn about MESH and hear first hand from women suffering such terrible complications – not to mention the longer I deal with my own pain and problems walking (which really isn’t THAT long compared to a lot of women), the more frustrating it all is.

To me, using mesh for SUI is sort of  like someone with yellow teeth wanting whiter teeth, but using a product that has a “not rare” risk of making all your teeth fall out, and maybe your face melt off too.  But, hey… ya might have a great smile IF it works.  ?!  Besides, it won’t kill ya.. so, it’s not life-threatening… you can LIVE with NO teeth, can’t ya ?!?

Ok, maybe that’s not the best analogy, but again… you get the gist, right??

References:
Full FDA alert:   http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

Short FDA notice:   http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079028.htm6

 

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Sept 25, 2012

The doctor doesn’t let the facts get in the way.

For some reason the doctor, an Ob/Gyn at Oakdale Obstetrics & Gynecology in the Minneapolis, Minnesota area tells patients (here) that “plaintiff lawyers are in “attack mode” and have demonized the MESH rather than the PROCEDURES that were ineffective.”

In other words – blame the bad lawyers and bad doctors, not the mesh.

That is not the only information that is demonstrably untrue. He says “most of these surgical products have also been removed from the market,” referring to mesh that erodes through the vagina.

That simply is not true. Most synthetic surgical mesh remains on the market.

On point one:

It was in 2008 and again in 2011 that the federal watchdog agency, the U.S. Food and Drug Administration (FDA) issued a Public Health Safety Notification (here) that said mesh complications are “not rare” and may include “pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems.” There were also reports of “recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.”

Many of these problems required additional surgeries, more mental and physical anguish and hospitalization as well as expense often added to a woman who can no longer work.

It doesn’t sound like a problem caused by a lawyer.

On point two:

Most synthetic polypropylene mesh remains on the market with the exception of four meshes that Ethicon is gradually discontinuing (background story here) and the Bard Avaulta that the company decided in July to stop selling in the U.S.

Why then does the doctor say, “the vast majority of this information (mesh controversy) comes from lawyer offices trying to secure business. Second, the mesh is not the problem, only certain surgeries using the mesh.”

In reality there were nearly 4,000 mesh-related injuries the FDA found in a three-year period from January 2008 to December 31, 2010.  And many of those mesh injuries were associated with “mid-urethral slings” used to treat incontinence which he says “are not criticized or questioned by the FDA.”

In fact the FDA’s July notification says, “The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.”

More and more women who go online and read about their complications tell MDND they are deciding to opt out of having a plastic mesh permanently implanted and go for a pessary or suture surgery alone.

Litigation over synthetic mesh used for the transvaginal treatment of prolapse and incontinence is growing. There are five cases consolidated in multidistrict litigation in the Southern District of West Virginia and a sixth MDL in the Middle District of Georgia.

Plaintiffs are filing defective product litigation in both state and federal courts with the first cases to be heard sometime in 2013.

On July 20, jurors in a Bakersfield, California state court determined that the Avaulta Plus Biosynthetic Support System vaginal implant caused Christine Scott’s chronic pain, mesh erosion, and incontinence and that she and her husband deserve the $5.5 million damage award after the Bard mesh eroded into her vagina, perforated her colon, leading to eight surgeries so far and ongoing, severe pain.

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Christine Scott, KGET-TV, Bakersfield, CA.

July 24, 2012 ~ BREAKING NEWS!

“Thank You God. We can finally get the word out to women.”

Those are the words of Christine Scott, 53, a former runner who had a vaginal mesh implant to treat stress urinary incontinence in 2008. After that her health went downhill as the synthetic mesh eroded into her colon.

KGET-TV 17 in Bakersfield reported late Monday night (here)  that the Bakersfield woman won a $5.5 million lawsuit she filed against mesh maker C.R. Bard. In the product liability action, Scott said she had the Avaulta Plus Biosynthetic Support System to correct some urine leakage, but it left her in chronic pain, incontinent, and unable to have intercourse.

“I don’t know if I have one or 100 surgeries ahead,” she said to the tv station.

The jury returned the verdict late Friday in Kern County Superior Court before Judge William Palmer. Scott told jurors she could only urinate with a catheter for five months. She then had to undergo eight additional removal surgeries. The Avaulta remains in her body as many surgeons feel the permanent implants cannot be safely removed.

The jury awarded Scot $5 million and her husband $500,000 for the loss of their relationship.

The lawsuit is a landmark victory and the first of its kind in the nation against a major mesh manufacturer. There are another 650 mesh cases pending against C.R. Bard and thousands pending against five other mesh manufacturers consolidated in multidistrict litigation.

Tested on Rabbits and Sheep

Attorney Elaine  Houghton said, “ They tested this on they tested 16 rats 12 rabbits 4 sheep  and by their own research the next living product this went into was a women.”

Houghton and her law partner, Gene Lorenz represented Scott.

KGET reports Bard stopped selling the Avaulta medical device on July 1, 2012 in the United States because the FDA wanted more clinical trials done.

The Bakersfield woman said the hardest part was having to keep quiet watching women continue to be hurt. In 2010 an estimated 200,000 women had synthetic mesh implanted to treat stress urinary incontinence. The actual complication rate is unknown since the U.S. does not monitor medical devices after they are implanted.

Synthetic meshes used to treat incontinence are  petroleum-based polypropylene. They are considered a Class II medical device and manufacturers are not required to conduct clinical trials for safety and efficacy before they are marketed.

When I got that verdict it was, Thank you God. Now we can do something,” said Scott.

FDA- Complications “Not Rare”

Scott filed a lawsuit against Bard and her doctor in January, 2009. In October 2008, the U.S. Food and Drug Administration filed the first of two Safety Notifications warning the public that there was a  degree of “rare” but “serious” complication association with mesh placement in some women. One year ago, the federal agency revised that notification and said that complications were “not rare.”

Many doctors have assumed that the FDA warnings primarily focus on synthetic transvaginal mesh for pelvic organ prolapse, not incontinence. This judgment flies in the face of that assumption.

Scott says she will start a support group. Patient Right to Know.org for people who have questions about surgical mesh.

C.R. Bard of Murray Hill, New Jersey plans to appeal. The Avaulta Plus is no longer sold in the U.S. but is sold globally.   #

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May 29, 2012

She blames a mid-urethral sling implanted in May 2008 on injuries that followed including debilitating pain and infections which necessitated corrective surgery in 2010.

Natick-based Boston Scientific is facing about 300 such lawsuits filed all over the country. The federal cases have been consolidated in Charleston, West Virginia along with federal cases filed against Ethicon, American Medical Systems and C.R. Bard.

In Middlesex County, Mass. another 100-plus lawsuits have been filed in state court, hoping the wheels of justice will turn quicker there than in federal court where the first bellwether trial is set for February of 2013.

The paper says there are nearly 1,300 federal lawsuits filed so far that all claim complications from synthetic mesh used to treat pelvic organ prolapse and incontinence in women.

It was July 2011 that marked the beginning of the multimillion dollar litigation wave when the U.S. Food and Drug Administration said complications from the transvaginal placement of mesh are not rare and that vaginal mesh may be no more effective than traditional repair using sutures alone. Many women who knew they suffered complications after their implant surgery had somewhere to turn, however, despite the warning,  mesh remains on the market and is implanted everyday.

An analyst for Northland Securities tells the reporter it’s taking longer for Boston Scientific and other medical devices to get a medical device cleared for market these days, though there is no expansion on that thought. The rules for approval have not been tightened to make marketing a device any more difficult.

Vaginal mesh represents less than five percent of Boston Scientific’s $7.6 billion in revenue last year, the paper reports.

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Andre Picard, Globe & Mail Columnist

The Toronto, Canada newspaper, The Globe and Mail, on May 7, Monday night published, “Time to discuss risks of surgical meshes.”

These are embarrassing issues to discuss says newspaper columnist, Andre Picard, because they involve so-called “private parts.” Most reporters don’t usually write about organs that protrude through the vagina or urine leakage when one moves, or coughs, which may explain why you haven’t heard much about synthetic mesh (unless you read this site and others!).

Getting to the facts, Picard says that 25,000 Canadians undergo surgery to treat stress urinary incontinence (SUI) every year and about 5,000 women undergo surgery for pelvic organ prolapse (POP).

Picard says “more than 90 percent of the SUI surgeries and 30 percent of the POP surgeries include the insertion of a mesh.”

The Globe and Mail story adds that in 2010 Health Canada, that country’s version of our Food and Drug Administration (FDA), issued a warning that complications from mesh are possible including pain, vaginal and urinary infections, injuries to the bowel, bladder, and vagina.

(A July 13, 2011 FDA Safety Notification came out strongly suggesting that these complications are Not Rare and that a mesh repair may present more risks than benefits.)

CTV, April 18, 2012 story on mesh class actions

Picard says the complication rate of mesh repair ranges from 2 to 15 percent, (though there is no data that has been made clearly available to date). Manufacturers say the complications may be due to “the skill and experience of surgeons, not the product itself.”

The Globe and Mail makes reference to a CTV News (Canadian television) story done April 18, by reporter Avis Favaro, who profiled two women injured by synthetic mesh who have joined a class action lawsuit in that country.

Favaro told MDND today, “We didn’t expect the response we got. We were flabbergasted by it and taken aback by the level of complications and their similarities.”

After her April story she says a flood of women began emailing and calling the station. CTV News did a second story about some of the women who had come forward. One Canadian lawyer told her his cases went from 15 to 200.

Favaro and the Globe and Mail report on a women suffering constant burning pain from her knees to navel. Another had been unable to work and has been on long-term disability for two years.  Another had her mesh pierce her vaginal wall. One woman who contacted the station reported that bits of purple mesh fibers were being expelled in her urine. Thoughts of suicide were a constant message.

MDND reported in November 2011 about the first Canadian mesh cases to be filed. Since then at least two class actions have been formed.

The Globe and Mail reminds readers that mesh is not intended to be removed so a long-term implant may be especially difficult to remove.

“In fairness, it has to be said that most patients have had good results with meshes. And, of course, every surgery involves risks.”

“But there are some basic questions that remain unanswered: Were the products properly tested before being used extensively? Were women adequately warned about the potential complications? Were other treatments such as Kegels (pelvic-strengthening exercises) and pessaries (small plastic devices inserted in the vagina or rectum for pelvic-floor support) discussed with patients who were given meshes? Were surgeons implanting the mesh competent?”

At least the columnist admits that the media is reluctant to talk about problems “down there” and that may have contributed to a lack of public awareness.

Learn More:

Globe and Mail, “Time to Discuss Risks of Surgical Meshes”  – May 7, 2012
http://www.theglobeandmail.com/life/health/new-health/andre-picard/time-to-discuss-risks-of-surgical-meshes/article2425399/

Globe and Mail Comments:
http://www.theglobeandmail.com/life/health/new-health/andre-picard/time-to-discuss-risks-of-surgical-meshes/article2425399/comments/

MDND: Canadian Courts Take Aim at Ethicon, April 23, 2012
http://meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices/canadian-courts-take-aim-at-ethicon/

MDND:  CTV – Canadian Class Action Lawsuit, April 18, 2012
http://meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices/ctv-canadian-transvaginal-mesh-class-action-lawsuit/

MDND: First Canadian Transvaginal Mesh Case Filed, November 9, 2011
http://meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices/first-canadian-transvaginal-mesh-case-filed/

Health Canada, Safety Notification, February 4, 2010
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/advisories-avis/prof/2010/surgical-mesh_nth-aah-eng.pdf

FDA, Notice, July 13, 2011 – FDA Safety Communication: UPDATE  on Serious Complications Associated with Transvaginal Placement of Surgical mesh for Pelvic Organ Prolapse:
This is a much more strongly worded (compared to the 2008 FDA notice) caution about surgical mesh, questioning whether benefit is worth the risk, but falls short of a recall.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htmDA,

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CTV story on mesh lawsuits

April 17, 2012 ~ CTV National News on Tuesday, April 17, ran a taped story of two women who are involved in a multimillion dollar class action lawsuit in Canada over vaginal mesh. The women are now disabled and unable to work as a result of being implanted with synthetic surgical mesh as a treatment for incontinence.

Carol Kouyoumjian had the Johnson & Johnson mesh made by Ethicon inserted around her bladder to treat incontinence six years ago. Since then she’s developed chronic leg pain she says is a “12” on a ten scale.  She can no longer work as a nurse because she can’t stand for any period of time.

Diane McLaughlin says the mesh, inserted in 2006, solved her bladder problem but it left her with severe leg pain. Both women say they were never warned about the long-term and debilitating problems either by their doctor or in the product literature.

There has been one warning about transvaginal mesh complications issued by Health Canada, however many doctors remain unaware of the warning. Synthetic meshes to treat pelvic organ prolapse, (POP) and stress urinary incontinence (SUI) are still on the market.

In July 2011, the FDA issued its second, stronger warning about complications.

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” the agency wrote to health care providers.

“Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

CTV reports the meshcomplication rate may be 15 percent, however the actual number of complications is unknown because patients are not tracked after surgery. In the states, the FDA database of  ‘adverse events’ is thought to represent about ten percent of actual injuries. Mesh is still in wide use with thousands of implants put into unsuspecting women every year.

Ethicon, the mesh manufacturer and a subsidiary of Johnson & Johnson, told the network:

“We are convinced the evidence will show we acted appropriately and responsibly in the research, development and marketing of these products.”

Both women in the CTV story have been told they will have to live with the mesh and the pain because it has now become part of their body.

The Canadian law firm, Siskinds LLP says they want better warnings for women considering mesh.

The Statement of Claim alleges that Johnson & Johnson failed to adequately warn patients and physicians of the magnitude of the risk of serious side effects when using one of their transvaginal mesh products compared to alternative treatments.  Possible side effects include mesh erosion through the vaginal wall, infection, pain, bladder perforation, vaginal scarring, pain during sexual intercourse, and other problems which may lead to a significant decrease in quality of life due to discomfort and pain.

Matthew Baer, a lawyer with Siskinds ^LLP, describes the purpose of the proceeding as:

 ”We believe that through this lawsuit Johnson & Johnson will be required to explain to Canadians what it knew about the risks associated with using their transvaginal mesh products and when they first became aware of those risks.  In this case, as with all of these types of cases, we are concerned about whether Canadians were adequately warned of the risks associated with using the products in question. These products are alleged to have high failure, injury and complication rates which could result in frequent and often debilitating re-operations and potentially cause severe and irreversible injuries, conditions and damage.”

Learn More:

CTV- Top Story
http://www.ctv.ca/CTVNews/TopStories/20120417/transvaginal-mesh-women-lawsuit-incontinence-120417/

Health Canada warning, February 4, 2010
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/surgical-mesh_nth-aah-eng.php
“Health Canada is concerned about Canadian and international reports of various intraoperative and postoperative complications associated with the use of these medical devices.”

Canadian News Wire on Transvaginal Mesh Class Action, April 17, 2012
http://www.newswire.ca/en/story/956349/transvaginal-mesh-class-action-commenced-in-canada

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Here is the Notice of Hearing.

The proceeding will consider whether the injured women should have their cases centralized before the U.S. District Court for the Southern District of West Virginia before Chief Judge Joseph R. Goodwin.

The Honorable Joseph R. Goodwin

The women all claim injuries following surgery with synthetic transvaginal mesh which range from intense pain, disability, mesh erosion and shrinkage, nerve damage, and infection, among other injuries.

The companies named in lawsuits include Boston Scientific Corp., American Medical Systems (acquired by Endo Pharmaceuticals Holdings), and Ethicon (Johnson & Johnson). The Food & Drug Administration (FDA) has received more than 4,000 reports of injuries to women who received the permanent implants to treat pelvic organ prolapse and incontinence which have led to hundreds of lawsuits, background story here.

The plaintiffs argue that claims by the injured women are substantially similar and Judge Goodwin is familiar with the Bard Avaulta mesh injuries and will understand how to handle claims where multiple mesh devices from different manufacturers were used on the same female patient.

Multidistrict Litigation (MDL)

An MDL is a special procedure in which noncriminal cases are consolidated into one court. An MDL is different from a class action lawsuit in that the MDL allows those injured to file individual product liability lawsuits while at the same time sharing discovery and experts and to benefit from a uniform set of rules and rulings.

An MDL cuts down on the cost of bringing a case forward.  One judge oversees discovery, rules and procedures while the cost of duplicating documents for thousands of plaintiffs is reduced making litigation more cost and time effective.

There must be common questions of facts pending in federal courts around the country to have the cases consolidated.

The Judicial Panel on Multidistrict Litigation meets in various cities to decide which request should be consolidated.

Benefit of MDL

For a large corporation an MDL is cheaper and allows fewer expert depositions, decreasing the change the person with knowledge will be inconsistent.

In an MDL, the damage amount awarded will be tailored to the individual’s damages they suffered as opposed to a class action where everyone is awarded the same amount regardless of their injury.

Plaintiff attorneys say that the costs of bringing the case forward is reduced for each plaintiff because the various law firms representing the women will be allowed to share the information they uncover during the discovery process in documents and depositions with the defendants, in this case the mesh makers. And a MDL does not preclude a woman suffering from damages from transvaginal surgical mesh to end up having her own trial.

The product liability litigation charges the companies knew or should have known their products were defective in their manufacture, their design and in their marketing materials in a failure to warn the public about the potential dangers.

The public became aware about the dangers of defective surgical mesh on July 13, 2011 when the FDA issued a safety notification warning that complications from the plastic petroleum-based mesh are “not rare” and questioning whether mesh provides any benefit over non-mesh surgery for pelvic organ prolapse and incontinence.

As recently as January 4, 2012, the FDA said in a notification

“Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.”

A Class III designation would required mesh manufacturers to conduct premarket approval, scientific studies for safety and efficacy on the permanent transvaginal mesh implant before they reach consumers. Presently mesh is a Class II device and those safety assurances are not required. #

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