Preview Newsletter
Ethicon Media Monitoring 5/16/2019
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Pelvic mesh is under fire. What should women with prolapsed organs do?
May 15, 2019 | Philadelphia Inquirer
By Marie McCullough
As women get older, their pelvic organs tend to sag. That’s a normal part of aging. -
Female Urinary Incontinence: Know the Non-Mesh Alternatives
May 15, 2019 | Mesh Medical Device News Desk
By Dr. Una Lee
It is important for all women to be educated on how their urinary tract works and options that exist when problems occur. -
Ouch! My hernia mesh is killing me!!!
May 14, 2019 | Honolulu Legal Examiner
By Wayne Parsons
I do not have an implant of what they call “hernia mesh”. But I have a lot of clients in Hawai‘iwho do. They are in pain. They do not know what to do.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Pelvic mesh is under fire. What should women with prolapsed organs do?
May 15, 2019 | Philadelphia Inquirer
By Marie McCullough
As women get older, their pelvic organs tend to sag. That’s a normal part of aging.
But for millions of them, the sagging gets so bad — causing discomfort, urine leakage, or interfering with sex — that they resort to reconstructive surgery.
Synthetic plastic netting was supposed to be a big advance in surgery for what doctors call pelvic organ prolapse.
Instead, “pelvic mesh” has become one of the biggest mass torts in U.S. history. Medical device makers are paying nearly $8 billion to settle the claims of more than 100,000 women who suffered complications including pain, organ damage, infection, and incontinence.
Last month, the U.S. Food and Drug Administration took tough action, ordering the two remaining manufacturers of transvaginal mesh for pelvic organ prolapse to stop all sales.
Here’s the kicker: The FDA’s ban does not apply to all pelvic mesh products, and certain types remain an important option in selected cases, particularly for treating urinary incontinence. Experts say the benefits of using the devices depend on the surgical route, the therapeutic goal, the skill of the surgeon, and other factors that are still being studied.
“Mesh is not just a ‘bad news’ story,” said University of Pennsylvania urogynecologist Lily A. Arya, a specialist in female pelvic medicine and reconstructive surgery. “My ultimate message is one of hope, that ongoing research and clinical trials will help to determine the best treatment for a complex condition.”
How can women (and the men who care about them) sort all this out? Here are some things to consider.Basic biology
The pelvic floor, the muscular base of the abdomen, supports the vagina, uterus, bladder, bowel, and rectum. When these muscles are weakened by childbirth, chronic coughing, obesity, genetic factors, and inevitable aging, one or more pelvic organs may sink into or against the vagina. The top of the vagina also can drop down into that structure.
The good news is, prolapse is no more troublesome than wrinkles for most women.
“It is very, very common,” Arya said. “The mere presence of prolapse on a pelvic exam doesn’t mean it needs treatment.”
The bad news is, when sagging causes symptoms such as pelvic pressure, a vaginal bulge, lower-back pain, sexual dysfunction, or urine leakage, there are no easy, effective fixes. Conservative remedies include pelvic muscle exercises and a pessary, a removable silicone device that is inserted into the vagina much like a diaphragm or tampon.
Many women turn to surgery. Over a lifetime, an estimated 7 percent to 19 percent of U.S. women have such a repair.
A variety of operations have been developed that use the woman’s own tissues to try to restore normal anatomy. But symptoms often recur and about a third of women need another operation, studies have found.
“For some women, the native tissue is too weak and you need to augment it,” said Cheryl Iglesia, an obstetrician-gynecologist and pelvic reconstructive surgeon at Georgetown University School of Medicine.
The debut of pelvic mesh
The evolution of mesh in prolapse surgeries was a classic example of marketing getting ahead of science.
Polypropylene mesh had been used since the 1950s to repair abdominal hernias. Gynecologists hoped mesh could reduce reoperation rates in prolapse surgeries, so in the 1970s, they began cutting it into desired shapes and inserting it through abdominal incisions. In the 1990s, they began cutting through the vagina, a minimally invasive route thought to shorten recovery.
“Over time, manufacturers responded to this clinical practice by developing mesh products specifically designed for pelvic organ prolapse repair,” says an FDA summary of the history.
None of the products, however, had to undergo clinical studies to see whether they actually were safe and effective. (And for gynecologists eager to do the delicate surgeries, manufacturers offered training courses that could be completed in just a few days.)
Pelvic mesh products came to market under a much-criticized medical device approval pathway called 510K. It allows diagnostic tests, surgical machines, heart valves, and other potentially risky devices to be “cleared” by submitting scientific evidence that they are equivalent to devices already on the market.
The first pelvic mesh, cleared in 1996, was a strip used as a sling to support the bladder and treat stress urinary incontinence — leakage that could be triggered simply by coughing or laughing. Bigger, bulkier products soon followed, most implanted “transvaginally” — through the vagina.
Between 2002 and 2013, the FDA says, it cleared more than 100 transvaginal meshes for prolapse — even as reports of serious complications mounted.
The FDA responded by taking an escalating series of actions beginning in 2008. It issued warnings that vaginal mesh products could contract, break, and “erode” into organs, causing infection, pain, vaginal scarring, urinary retention or incontinence, recurrent prolapse, and more. Then the agency reclassified vaginal mesh and ordered manufacturers to conduct clinical trials. Most makers withdrew their products, instead.
The two companies that conducted studies — Boston Scientific and Coloplast — “have not demonstrated a reasonable assurance of safety and effectiveness of these devices,” the FDA declared last month in ordering the end of sales.
Balancing risks and benefits
The FDA order does not apply to pelvic mesh placed through the abdomen, or to mesh used to treat incontinence.
The American Urogynecologic Society is among medical groups that say mesh slings are a vital option for incontinence, and the benefits are now established by studies.
The slings “are a standard of care for the surgical treatment of stress urinary incontinence and represent a great advance in the treatment of this condition for our patients,” the society says.
Arya, the Penn urogynecologist, thinks banishing all pelvic mesh “would be throwing the baby out with the bathwater.”
Shanin Specter disagrees. His Philadelphia law firm has won a string of verdicts for women treated with all types of pelvic mesh products. The most recent came a week after the FDA order. A Philadelphia jury awarded $120 million — believed to be a record in mesh cases — against Johnson & Johnson and its Ethicon subsidiary on behalf of an Altoona, Pa., woman who had mesh implanted to treat incontinence.
Also last month, Washington State Attorney General Bob Ferguson announced that Johnson & Johnson agreed to pay $9.9 million to avoid going to trial for failing to disclose risks in the instructions and marketing materials for surgical mesh devices, including those for incontinence. More than 60 gynecologists and surgeons sent a letter protesting the consumer-protection lawsuit, arguing that it might scare patients away from the best treatment.
Ella Ebaugh of Manchester, Pa., was unaware of the risks of mesh. She just wanted to stop leaking when she ran during softball games about 15 years ago. But several years after getting her second J&J mesh implant — the first didn’t help — she developed severe pain and urinating became difficult. Mesh had eroded through her bladder and urethra, causing irreparable damage. In 2017, she won a $57 million verdict, which is on appeal.
“When I grew up, you trusted your doctors. And I’m a trusting person. I think most women are,” Ebaugh, now 53, said in a recent interview. “J&J manipulated the data. They knew these risks and didn’t disclose them to doctors or patients. As a patient, you can do your research. But how do we know they’re telling the truth?”
https://www.philly.com/health/pelvic-mesh-prolapse-incontinence-ethicon-jj-20190515.html
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Female Urinary Incontinence: Know the Non-Mesh Alternatives
May 15, 2019 | Mesh Medical Device News Desk
By Dr. Una Lee
It is important for all women to be educated on how their urinary tract works and options that exist when problems occur. A mid-urethral mesh sling is a common surgery that treats stress urinary incontinence. It has been one of the standard surgical treatments for stress incontinence since 1997. The synthetic mesh sling works by acting as a “hammock” under the urethra, helping to keep it closed with activities like coughing or sneezing. However, women should be aware that there is an infrequent but known risk of minor, moderate or serious complications associated with mesh sling surgery. Many women ask if there are alternatives to mesh slings. Absolutely!
First, a quick review of incontinence basics. Urinary incontinence is the leakage of urine that can occur in women of all ages, and commonly occurs or worsens after childbirth. There are difference types of urinary incontinence, including: Stress incontinence – leakage with physical activity, like laughing or coughing Urgency incontinence – leakage that occurs when you have a strong urge to urinate and are rushing to the bathroom Mixed urinary incontinence – a common condition of having both stress and urgency incontinence Post-void dribbling – leakage after you urinate Incontinence without sensation – leakage that occurs with no awareness
The type of incontinence is important, because different treatments target different types. Also, the amount of leakage – mild, moderate or severe – will also affect treatment options.
Starting with the least complicated, conservative management may be appropriate if urinary leakage is mild, infrequent, not very bothersome and can be controlled with pads. For many women, no treatment is a valid choice.
Weight loss is another non-surgical opportunity. Studies have shown that modest amounts of weight loss (5 percent of total body weight) can significantly decrease urinary incontinence. For many women this is motivating and encouraging, while promoting their overall health.
Stopping smoking is another effective step. Smoking and the chronic cough associated with tobacco use can make urinary leakage worse. Abdominal pressure from frequent coughing will in turn increase pressure on the pelvic floor and urethra, causing leakage.
Pelvic floor physical therapy with a qualified physical therapist who specializes in urinary incontinence is a totally natural option. You learn how to identify and strengthen your pelvic floor muscles correctly and how to use this skill to prevent leakage. This therapy is known to be effective and is a skill you can use for life.
Incontinence pessaries are medical grade discs that are placed in the vagina to support the urethra. The size and shape is custom fitted to you, and it is removable and comfortable. It is a good non-surgical option to try.
Urethral bulking is an injection into the inner lining of the urethra, which improves the sealing abilities of the inner part of the urethra. While not generally permanent, it’s an effective treatment for the right patient.
The Burch procedure preceded sling surgery as a standard stress incontinence treatment. Instead of creating a hammock supporting the urethra, sutures are placed for support and elevation. While not as effective as the sling procedure, the Burch procedure remains an option for some patients.
A variation on the sling procedure known as the autologous fascial sling has been around for years and has stood the test of time. A strip of fascia, or connective tissue, is harvested from your thigh or lower abdomen, then placed to support the urethra. While this surgery is effective, durable and safe, the downside is that it’s more invasive and requires longer healing time.
Enrolling in a clinical trial may be an option for some patients. Eligible participants volunteer and are fully informed of the study’s process and potential risks and benefits. Participants are advised to talk to their health care provider before participating in a clinical trial. One study is currently investigating using muscle-derived, regenerative cells to treat stress urinary incontinence. For more information on participating in clinical trials, click here.
Vaginal laser treatments, using a carbon monoxide (Co2) laser, are used as a therapy for vaginal dryness and atrophy. Currently, there is not enough evidence to support the claims that they treat stress urinary incontinence. Additionally, laser treatments are costly and typically not covered by insurance.
Medications for urinary incontinence generally help with urgency incontinence and overactive bladder symptoms, but not stress urinary incontinence. So they can help with that “gotta go” feeling and resulting leakage, but not with leakage that happens during Zumba class. These medications are designed to help with bladder control. Most are prescription, so ask your doctor if bladder medications are appropriate for you. One treatment, the oxybutynin transdermal patch, is available over the counter. Side effects can occur with these medicines, with about 20 to 40 percent of women remaining on the medication in one year’s time.
Treatment with vaginal estrogen helps treat thinning tissues in the vaginal area. By improving the quality of the tissues, symptoms of urinary urgency can improve. Some women report their incontinence improves as well.
Botox injections in the bladder can dramatically help women who have leakage of urine that is associated with urgency, but are not effective for stress urinary incontinence.
Bladder pacemakers, also known as InterStim therapy, regulate bladder signals by stimulating the sacral nerves located near the tailbone. This electrical stimulation helps the brain and bladder communicate for better urinary control. The implants help reduce urinary urgency and resulting leakage, urinary frequency and urinary retention (the inability to empty the bladder).
Urinary incontinence is a common, costly and important quality of life issue for women. Gaining a thorough understanding of the condition is the first step. Given the sensitive nature of these bodily systems and their impact on women’s lives, knowing the range of treatment options is key to making the right choice for you.
https://www.meshmedicaldevicenewsdesk.com/female-urinary-incontinence-know-the-non-mesh-alternatives/
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Ouch! My hernia mesh is killing me!!!
May 14, 2019 | Honolulu Legal Examiner
By Wayne Parsons
I do not have an implant of what they call “hernia mesh”. But I have a lot of clients in Hawai‘iwho do. They are in pain. They do not know what to do. Their doctors warn them that a second surgery to remove or revise the mesh is “risky”. How risky? It depends on the exact condition of each patient. But risky it is.
What is one one word to describe what it feels like to have a defective mesh inside your body? Its a nightmare!
My clients were turned off by the 800-# television and internet advertisements about hernia mesh lawsuits and claims. I don’t blame them. If you call those 800-#’s you will be talking to a call center. They are case brokers.
My suggestion? Stay in the 808. Insist on sitting across the table from the lawyer who will represent you, and who will meet you and answer your questions.
Its Hawai‘i. That’s how we do things here. Face to face. You ask. I answer.
I also do not expect my clients to trust me, just because I live in Honolulu and have been in the Islands since 1967. Trust _ always _ must be earned. I accept that challenge. Face to face.
Every person is different. Every hernia mesh case is different. I never let my guard down. We start with: “tell me what happened”?. We talk story. Serious story. But we talk. I listen to you.
My cellphone is 808-753-0290. I live in Kaimuki. I am well known in all 50 states as a trial lawyer. Check me out. The, you decide.
NOTE: A resident of Honolulu, Hawaii, Wayne Parson is an Injury Attorney that has dedicated his life to improving the delivery of justice to the people of his community and throughout the United States. He is driven to make sure that the wrongful, careless or negligent behavior that caused his clients' injury or loss does not happen to others.
https://honolulu.legalexaminer.com/health/ouch-my-hernia-mesh-is-killing-me/
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