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Ethicon Media Monitoring 6/27/2017
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AdvaMed Backs Johnson & Johnson in Supreme Court Appeal of $3m Pelvic Mesh Loss
Jun 26, 2017 | Mass Device
By Brad Perriello
The medical device industry’s largest national lobbying group, AdvaMed, is backing Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon in its appeal to the U.S. Supreme Court over a $3.3 million loss in a product liability lawsuit brought over its TVT-O pelvic mesh. -
'It Was Like Somebody Scratching You From Inside Your Body': NHS Hernia Mesh Repairs Leave Thousands at Risk of Constant Pain
Jun 26, 2017 | Daily Mail
By Daisy Dunne
Thousands of patients have been left at risk of chronic pain after being fitted with hernia mesh repairs by NHS doctors, experts have warned. Thousands of patients have been left at risk of chronic pain after being fitted with hernia mesh repairs by NHS doctors, experts have warned. -
Alarm at Travel Impact of Vaginal Surgery Difficulties for NI Women
Jun 27, 2017 | BBC
By Marie-Louise Connolly and Catherine Smyth
A leading Harley Street gynaecologist has said she is "astonished" that a group of women in Northern Ireland felt they had no option but to seek help in England after vaginal surgery left them with "shocking" complications. -
Medical Monday: Uterine Fibroids (UFE)
Jun 26, 2017 | News Channel 5
One-third of American women experience some type of pelvic health disorder by the time they're age 60. And about 600,000 women every year have a hysterectomy -- removing their uterus to relieve troubling symptoms.
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AdvaMed Backs Johnson & Johnson in Supreme Court Appeal of $3m Pelvic Mesh Loss
Jun 26, 2017 | Mass Device
By Brad Perriello
The medical device industry’s largest national lobbying group, AdvaMed, is backing Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon in its appeal to the U.S. Supreme Court over a $3.3 million loss in a product liability lawsuit brought over its TVT-O pelvic mesh.
A jury in the U.S. District Court for Southern West Virginia awarded Jo Huskey and her husband damages of $3.3 million, finding in September 2014 that the TVT-O transvaginal sling caused her injuries and that the company failed to warn about the stress urinary incontinence treatment’s risks. A federal judge later shot down Ethicon’s bid to overturn the verdict and denied the company’s move for a new trial; Ethicon then appealed to the U.S. Court of Appeals for the 4th Circuit.
In January a 3-judge panel at the 4th Circuit denied the appeal, ruling that the Huskeys proved their case.
Ethicon’s petition for certiorari to the Supremes, filed May 23, alleges that the appellate court improperly excluded product review evidence after misreading the relevant precedent.
Today AdvaMed’s assistant general counsel, Matthew Wetzel, said the trade group filed an amicus curiae brief with the Supremes last week, asking them to review a lower court decision blocking the introduction of evidence that J&J met the FDA’s 510(k) clearance requirements.
“Representing much more than a disagreement over what evidence is admissible, the case provides a chance to restore fundamental principles of fairness and transparency in fact-finding efforts at trial,” Wetzel said in prepared remarks. “We are asking the court to grant a writ of certiorari to hear the case, which could reverse a trend of evidentiary decisions in the 4th Circuit and beyond that prohibit defendants in medical product liability cases from presenting evidence of a product’s 510(k) premarket clearance. In effect, such decisions prevent juries from hearing the full story, which is fundamentally unfair. Worse, it can result in FDA’s assessment of a product’s safety and effectiveness being supplanted by a court ruling.”
“We believe that the Supreme Court has an opportunity to level the playing field and give medical device manufacturers a fair shake at defending themselves,” added Ann Bunnenberg, president & COO of Electrical Geodesics and chairwoman of AdvaMed’s legal committee.
http://www.massdevice.com/advamed-backs-johnson-johnson-supreme-court-appeal-3m-pelvic-mesh-loss/
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Jun 26, 2017 | Daily Mail
By Daisy Dunne
Thousands of patients have been left at risk of chronic pain after being fitted with hernia mesh repairs by NHS doctors, experts have warned.
NHS England said mesh implants are the 'recommended method' for treating a hernia, which occurs when an organ or fatty tissue protrudes through an area of weak muscle in the body.
The treatment, which is carried out on thousands of patients every year, involves pushing the hernia back into the abdomen and covering it with mesh material.
But almost half of those who have received mesh implants are at risk of developing chronic pain, according to a new investigation by the BBC's Victoria Derbyshire programme.
Surgeons warned that the risks of the treatment are 'so bad' that a mesh-free alternative method must be found to prevent thousands from being left in agony.
The warning comes just weeks after 800 women announced that they are suing the NHS over the use of vaginal mesh implants, which left many unable to walk, work or have sex. 'I could feel the mesh'
Mother-of-two Leila Hackett received umbilical hernia mesh repair four years ago.
'Straightaway I could feel the mesh,' she told the BBC.
'It was like somebody scratching you from inside your body, it's so unpleasant and constant.'
Ms Hackett went to her GP in agony many times, but was assured that mesh was not causing her pain.
After two years, she was admitted to hospital after the mesh implant became attached to her internal organs, which caused her bowel to twist.
She said she was left 'screaming' in agony and surgeons took four hours to pick the pieces of mesh from around her organs.Up to half of patients at risk of chronic pain
One in ten people in the UK develop a hernia in their lifetime.
Now experts have warned that thousands of patients could be living with chronic pain after being fitted with mesh implants.
Peter Jones, a former general surgeon from Kent, told the BBC he spent much of his career removing mesh implants from hernia patients.
At least half of patients who have a mesh repair will have a smooth recovery, but in my opinion the risks of a poor outcome are so bad, I wouldn't want to take that risk,' he told the BBC.
He added that more people should come forward to talk about their suffering, saying this could put a 'dent' in the NHS' commitment to hernia mesh repairs. Alternative treatment
Some surgeons have called for the NHS to offer its patients a mesh-free alternative treatment for hernias in the groin.
Doctors in Canada have pioneered a technique called Shouldice hernia repair, which involves covering bulges with overlapping layers of the abdominal wall.
The treatment was developed at the Shouldice Hernia Centre in Toronto and has a 99.5 per cent lifetime success rate for groin hernias.
In comparison, mesh repair treatment has a 90 per cent success lifetime success rate, according to NHS Choices.
But the NHS said Shouldice repair was hard to replicate in its hospitals and that mesh repairs had proved successful for patients over many decades, according to the BBC.
http://www.dailymail.co.uk/health/article-4639024/NHS-hernia-mesh-repairs-leave-thousands-agony.html
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Alarm at Travel Impact of Vaginal Surgery Difficulties for NI Women
Jun 27, 2017 | BBC
By Marie-Louise Connolly and Catherine Smyth
A leading Harley Street gynaecologist has said she is "astonished" that a group of women in Northern Ireland felt they had no option but to seek help in England after vaginal surgery left them with "shocking" complications.
The women had mesh or tape implants.
These are devices used to treat organ prolapse and urinary incontinence, conditions that can be common after childbirth.
Some of the women now have difficulty walking or sitting.
Others have had to give up work and looking after their children.
BBC News NI can reveal that a number of clinicians in Northern Ireland were sufficiently alarmed by reports of complications in other jurisdictions that they are conducting an evaluation of patients who have had the operation in Northern Ireland.
In a statement, the Department of Health said it is "essential that clinicians that conduct these operations carry out audits to ensure they are performing to the highest possible standards".
Dr Sohier Elneil is the consultant urogynaecologist who has seen or been in contact with more than ten women from Northern Ireland.
"I was astonished because these are young women, in their late 30s or 40s or early 50s," she said.
"The shock for me was you would see them but they are unable to function as a mum, a wife or as a member of society and I think that really hit home."
Dr Elneil said she was surprised that the women had to travel to seek help.
"I think it was a bit of a shock for a lot of us in the field just how bad the situation was and as Northern Ireland is part of the UK I am not surprised that the problems exist there.
"It was just people hadn't realised it was as big a problem as it is currently.
"I would have expected that they would have had access to the care they needed as I know there are many great and capable doctors there."
Dr Robin Ashe, a retired gynaecologist, is chairing the audit into mid-urethral tapes in Northern Ireland.
He described the situation regarding the operation as "evolving".'Pathway of care'
"It's come to light in the past number of years and, for us, the UK and the Scottish experience has been telling," he said.
"So, a group of clinicians came together and thought - let us look at Northern Ireland and see are we in the same boat, we need to find out where we stand.
"I will say this though that the vast majority of patients undergoing the operation have a straightforward progress and do not experience problems."
The audit is studying a group of women in Northern Ireland who had mesh implants in 2013.
It is examining their preparation for the operation, consent issues, and any complications during and immediately afterwards.
The audit would also like to look at longer-term implications but has not yet received permission to do so.
Dr Ashe said the evidence shows that the mesh itself is safe to use.
One woman who paid privately to have her mesh removed said her life has been transformed. She does not want to be identified because she works for the police.
"I no longer feel like a 90-year-old woman - the stiffness, the pain in my pelvic area, hips and my groin and my lower back has reduced massively.
"In fact the back pain has gone, my psoriasis has gone from nails and head, I don't use steroids any more," she said.
"I feel more positive and feel that over the next few months that I will improve. I would hope I will get into doing some form of exercise since I haven't been able to do that for years."
For Dr Elneil, it is important that the women's voices are now heard
"I would like to see a concerted effort by us as a professional group, by the regulatory authorities, to work with us and with the patients because one of the issues the patients face is not the anger about the device directly but the fury they cannot get help when the problems arise," she said.
"So if we had a very well stipulated pathway of care put in place when things go wrong that would go a long way to making patients feel they are being listened to and they are getting the right access to care they need."
http://www.bbc.com/news/uk-northern-ireland-40410835
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Medical Monday: Uterine Fibroids (UFE)
Jun 26, 2017 | News Channel 5
Dr. Dan Wunder explains what are uterine fibroids and the process of uterine fibroid embolization. Medical Mondays is sponsored by AdvancedHEALTH.
News Notes via www.webMD.com
One-third of American women experience some type of pelvic health disorder by the time they're age 60. And about 600,000 women every year have a hysterectomy -- removing their uterus to relieve troubling symptoms. Overall, an estimated 20 million women have had a hysterectomy. But if you have painful periods with excessive bleeding, fibroids, endometriosis, or another pelvic health problem, you should know that there are alternatives to hysterectomy to consider.
HYSTERECTOMY ALTERNATIVES
Uterine Fibroids
These tumors, usually benign, are generally found on the smooth muscles of the uterus, and can cause pelvic pain, infertility, and heavy menstrual bleeding. Uterine fibroids are a major reason why women have hysterectomies, accounting for between 177,000 and 366,000 of the annual total.
If your fibroids are causing no symptoms, it's entirely reasonable to adopt a strategy called "watchful waiting" -- monitoring their status with your doctor and not having any surgery unless problems develop. But if you are experiencing pain, discomfort, or pressure, there are several less-invasive options for treating fibroids: · Myomectomy. This is the surgical removal of the fibroids alone. It can be done through an abdominal operation, laparoscopically (entering through the navel), or via hysteroscopy (inserting a thin, telescope-like instrument called a hysteroscope through the vagina). A laparoscopic or hysteroscopic approach is least invasive, and these are also less costly and require shorter recovery time. The da Vinci robotic myomectomy is another technique that offers precision and smaller incisions. There is a small chance that what was thought to be a fibroid could instead be a cancer called uterine sarcoma. For this reason, the FDA recommends not cutting the fibroid into small sections before removing it, a process called laparoscopic morcellation.
· Uterine artery embolization (UAE), also known as uterine fibroid embolization (UFE). This is a fairly simple, noninvasive procedure in which small particles are injected into the uterine arteries feeding the fibroids, cutting off their blood supply. Unlike a hysterectomy, this procedure preserves the uterus and helps women potentially avoid surgery. It's been used for years to help stop hemorrhage after childbirth or surgery. Symptoms improve in 85% to 90% of patients, most of them significantly. · Hysteroscopy. The insertion of a thin, telescope-like instrument through the vagina can be used if the fibroid is primarily within the cavity of the uterus. This is a minor surgical procedure with minimal recuperation time, but can only be offered to women who have fibroids within the lining of the uterine cavity.
Medical management. Painful symptoms of uterine fibroids can be initially treated with nonsteroidal anti-inflammatory drugs (NSAIDs), like Motrin. If that isn't effective, another option is a class of drugs that blocks the ovaries' production of estrogen and other hormones. Their side effects can include symptoms of premature menopause and a decrease in bone density. This is done only prior to scheduled fibroid removal, not long term. The fibroids will grow again after therapy is stopped.
Menorrhagia Menorrhagia means heavy vaginal bleeding. In many cases, the bleeding has a known cause, like uterine fibroids (see above), but in other cases the cause remains unknown. There's a medical threshold for menorrhagia -- losing more than 80 mL of blood in each menstrual cycle -- but most doctors now tend to define menorrhagia by how much it affects your daily life: causing pain, mood swings, and disruptions in your work, sexual activity, and other activities.
Some options for treating menorrhagia, short of hysterectomy:
Medical management. Menorrhagia's first treatment of choice is medical, using either oral contraceptives or an intrauterine device (IUD) that releases a hormone called levonorgestrel. Both of these treatments reduce menstrual bleeding significantly, although women report being generally more satisfied with the IUD. If you're still planning to have children in the future, these are probably your best options. · Endometrial ablation. There are a variety of techniques that can be used to remove the lining of the uterus. You should only consider these options, however, if you are done with childbearing. New, "second-generation" methods like thermal balloon ablation, cryoablation, and radiofrequency ablation have success rates up to 80%-90%. These are all outpatient procedures mostly done in the doctor's office, so they don't have the same complication rates and extended hospital stays involved in hysterectomy.
· Occasionally, an NSAID is prescribed during menses to help reduce blood flow to the uterine lining.
Uterine Prolapse
Uterine prolapse happens when your uterus drops from its normal position and pushes against your vaginal walls. It can be caused by a number of things, but one of the most common causes is vaginal childbirth. Advancing age, smoking, pregnancy, and obesity are also significant risk factors.
Obviously, a hysterectomy will solve this problem -- but there are less drastic approaches that you can also consider. One treatment option is a vaginal pessary -- a removable device placed into the vagina to support areas where prolapse is happening. There are several different kinds of pessaries, and your doctor can help you decide which is best for your situation. They don't cure the prolapse, but can relieve symptoms partially or completely. Often, they can be helpful in pregnancy, holding the uterus in place before it enlarges and invades the vaginal canal.
There are also multiple surgical methods for treating uterine prolapse, and surgeons may use more than one technique. Sometimes, they will have to be combined with a hysterectomy, but for some women it is possible to avoid this step.
The risks of placing mesh through the vagina to repair pelvic organ prolapse -- a procedure done roughly 75,000 times in 2010 -- may outweigh its benefits, according to the FDA. However, the use of mesh may be appropriate in some situations.
Other types of surgery include paravaginal defect repairs and repairs of enteroceles, rectoceles (hernias of the intestine or rectum into the vagina), and cystoceles prolapse of the bladder into the vagina.
Endometriosis About 5 million American women experience endometriosis, which occurs when tissue that behaves like the lining of the uterus -- the endometrium -- grows in other areas of the abdominal cavity, such as the ovaries, fallopian tubes, or outer surface of the uterus. Symptoms include pelvic pain, painful intercourse, spotting between periods, and infertility. The average woman with endometriosis has symptoms for two to five years before being diagnosed.
About 18% of hysterectomies in the U.S. are performed due to endometriosis -- and it doesn't necessarily cure the problem. As many as 13% of women see their endometriosis return within three years if their ovaries are intact; the number climbs to 40% in five years. And since endometriosis often affects young women -- with an average age of about 27 -- a surgical option that removes all possibility of pregnancy isn't really an alternative. Treatments for endometriosis depend on the severity of the symptoms and the woman's needs. For example, pain can be treated with over-the-counter or prescription pain relievers. To treat pain and abnormal menstrual bleeding, women may be prescribed hormonal treatments such as birth control pills or drugs that drastically reduce estrogen levels. These drugs, however, aren't for women who are trying to get pregnant, and they are not a permanent treatment: Going off the medication usually means the endometriosis symptoms come back. A more long-term treatment for endometriosis that is more likely to help with fertility problems is laparoscopic surgery, a minimally invasive approach to either remove the endometrial growths and scar tissue, or burn them away with intense heat. If the growths can't all be safely destroyed this way, surgeons can take a more invasive approach, a laparotomy, which involves making a larger cut in the abdomen. This requires a much longer recovery period, but is still less invasive than hysterectomy and offers the prospect of retaining fertility.
Chronic Pelvic Pain Chronic pelvic pain affects many women: Some studies indicate that as many as 39% of women have some kind of chronic pelvic pain. It's most common in younger women, especially those between 26 and 30 years old.
Pelvic pain can be caused by many things, including the above-mentioned uterine fibroids and endometriosis, pelvic inflammatory disease, and bowel and bladder issues like irritable bowel syndrome, interstitial cystitis (an inflamed bladder), and musculoskeletal issues. Women who have experienced sexual abuse are also more likely to experience chronic pelvic pain.
A hysterectomy should be considered a last resort for chronic pelvic pain, especially since many types of pelvic pain aren't cured by the surgery. It's important to work with your doctor to uncover the specific cause of your pain so that the treatment can be targeted to that cause, giving you the best chance of relief. For example, if you are diagnosed with uterine fibroids or endometriosis, one of the treatment options described above might have the best chance of putting an end to chronic pelvic pain.
Other treatment options, depending on the cause of your pain, may include: · Stopping ovulation with hormonal methods like birth control pills
· The use of nonsteroidal anti-inflammatory medications · Relaxation exercises, biofeedback, and physical therapy
· Abdominal trigger point injections; medication injected into painful areas in the lower wall of the abdomen can help relieve pain. · Antibiotics (if an infection, such as pelvic inflammatory disease, is the source of the pain)
· Psychological counseling
It's still possible that, whatever your health condition might be, a hysterectomy may be the most effective and appropriate treatment. But with many alternatives available, it's important to discuss all your options with your doctor first.
UTERINE FIBROID EMBOLIZATION [UFE] Treatment Overview Uterine fibroid embolization (UFE) is a procedure done by a radiologist. It blocks blood flow to fibroids in the uterus. (It is also called uterine artery embolization.) For women who are not planning a pregnancy in the future, UFE is a possible option in place of surgery for fibroids.
Follow your doctor's instructions exactly about when to stop eating and drinking, or your procedure may be canceled. If your doctor has instructed you to take your medicines on the day of your procedure, do so using only a sip of water. About an hour before the procedure, you may be given a sedative to help you relax. It will not put you to sleep, because it is important that you be awake to follow instructions during the procedure. First, a thin, flexible tube called a catheter is placed into a blood vessel in the upper thigh (femoral artery). A substance called contrast material is then injected into the catheter. You may feel a warming sensation as it travels up to the uterus. The radiologist uses real-time X-ray on a video screen (fluoroscopy) to see the arteries and then guides the catheter to the arteries that supply blood to the fibroid. A solution of polyvinyl alcohol (PVA) particles is injected into those uterine arteries through the catheter. These particles build up in the targeted arteries and block blood flow to the fibroid.
What To Expect After Treatment
Uterine fibroid embolization usually takes between 1 and 3 hours, depending on how long it takes to position the catheter and how easy it is to position the catheter in the arteries in the uterus. When the procedure is over, the catheter is removed and pressure is applied to the puncture site for 10 to 15 minutes, unless there are problems with bleeding. A bandage is then applied. You can expect to have at least 6 hours of bed rest after the procedure.
You may be sent home after the bed rest period if your pain is under control, or you may spend the night in the hospital for more observation or pain control. This will depend on your radiologist's normal practice. And it will depend on how well you do after the procedure. Moderate to severe pelvic pain is common for 6 to 12 hours after this procedure. A stay in the hospital and narcotic pain medicine are used to control this pain, if needed. You can also ask for antinausea medicine if you have nausea or vomiting. Some women are able to control their pain with nonsteroidal anti-inflammatory drugs, such as ibuprofen or aspirin. Be safe with medicines. Read and follow all instructions on the label. You may have some vaginal bleeding for a couple of weeks. This is from a fibroid that is breaking down and bleeding.
In some cases, bleeding or pain persist for several months. Some women also pass a fibroid from the vagina, usually 6 weeks to 3 months after having UFE. This can happen even a year
afterward. If you do pass fibroid tissue, see your doctor right away to be sure that you do not develop infection or problem bleeding.
You should be able to return to your usual activities in 7 to 10 days.
Recommended follow-up care after UFE includes a checkup 1 to 3 weeks afterward and an ultrasound or MRI 3 to 6 months later.
Why UFE? Uterine fibroid embolization is used to shrink or destroy uterine fibroids. It is one type of treatment used in women who do not wish to treat fibroids with hysterectomy, do not plan to be pregnant in the future, and have not reached menopause. Although there are no size limits, UFE is not recommended for all types of fibroids. If you are strongly against ever having a hysterectomy, UFE may not be a reasonable option for you. In some cases of infection or uterine damage, UFE has led to a need for a hysterectomy.
How Well UFE Works
UFE is an effective treatment, but fibroids may return. · Uterine fibroid embolization reduces the size of fibroids an average of about 50%.1
· Approximately 80 out of 100 women treated with UFE for uterine fibroids report that their symptoms improved.1
· UFE does not always cure fibroids. In one study, nearly 1 out of 5 women who had UFE had a repeat UFE or a hysterectomy within the next couple of years.2
Risks of UFE
The rate of complications after UFE is low but includes:
· Infection. This is the most serious, potentially life-threatening complication of UFE. In rare cases, hysterectomy is needed to treat an infected uterus. · Premature menopause. This seems more likely to happen to women over 40 years of age than in younger women.
· Loss of menstrual periods (amenorrhea).
· Scar tissue formation (adhesions).
· Pain that lasts for months.
What To Think About UFE may not be a good choice if you want to get pregnant. It's possible to get pregnant afterward, but it's uncertain how good the odds are. This procedure does have a risk of damaging an ovary or the uterus, which would make it much harder to get pregnant. There may be a higher risk for pregnancy problems.
For a uterine fibroid embolization, be sure that you have a specially trained interventional radiologist who has a lot of experience with the procedure.
Uterine fibroid embolization may be a good treatment option for women who do not wish to receive blood transfusions (which can be needed after myomectomy) or who have other serious health conditions that make general anesthesia dangerous. UFE is not safe for women who are allergic to contrast material (used for fluoroscopy during UFE). UFE has several advantages over hysterectomy, myomectomy, and treatment with GnRH-a (the hormone-suppressor medicine used to shrink fibroids).
· General anesthesia and an abdominal (belly) incision are not required.
· There is no blood loss.
· All fibroids may be treated at the same time. · It does not cause bone-thinning (osteopenia) or the other serious side effects associated with GnRH-a therapy.
Disadvantages of UFE include:
· Cost. UFE is as expensive as hysterectomy.
· An unpredictable effect on fertility. It is not recommended for women who hope to become pregnant.
· The possibility of delayed infection sometime in the first year, which can become life-threatening if not treated.
· Not being a sure cure. In one study, nearly 1 out of 5 women who had UFE had a repeat UFE or a hysterectomy.2 · The possibility that some insurance plans will not cover this procedure.
http://www.newschannel5.com/plus/medical-monday/medical-monday-uterine-fibroids-ufe
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