Vaginal Mesh Study: Complications More Likely With Lower-Volume Surgeons

How do you minimize risk when undergoing surgery, an inherently risky endeavor?

If you happen to be one of the thousands of women facing surgery to treat stress urinary incontinence (SUI) — that uncontrollable leakiness due to weakened pelvic muscles, and yet another injustice of middle-age — there’s one pretty clear path to lower risk: Find a surgeon who performs many, many of these operations.

In a new analysis, Canadian researchers reviewed 10 years of data from nearly 60,000 patients who had vaginal mesh surgically implanted to treat stress urinary incontinence. The study concludes: “Ten years after SUI mesh surgery, 1 of every 30 women may require a second procedure for mesh removal or revision. Patients of lower-volume surgeons have a 37% increased likelihood of having a complication.”

The findings, published in the journal JAMA Surgery, “support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” the researchers write.

In case you’ve missed it, vaginal mesh implants have been in the news lately — and the news isn’t good. In May, a Delaware jury awarded $100 million to a woman who sued Boston Scientific, one of the manufacturers of vaginal mesh devices, for negligence, breach of warranty and fraud. Many more cases are pending and regulators continue to scrutinize the devices.

Patients and advocacy groups have also raised major concerns about the safety of vaginal mesh, the study authors note, citing complications ranging from chronic pain (and specifically, pain during sex) and fistula to erosion of the mesh into the vagina, which can require multiple followup surgeries and, needless to say, emotional and physical distress. More than 50,000 women have joined class action lawsuits related to vaginal mesh complications after SUI and prolapse procedures, the study says.

In an editorial accompanying the new analysis, Quoc-Dien Trinh, MD, a urologic surgeon at Boston’s Brigham and Women’s Hospital and assistant professor of surgery at Harvard Medical School, writes: “Although the lay press has focused on the judicial aspect and the potential financial fallout for manufacturers, little attention has been paid to understanding the factors associated with adverse events after vaginal mesh-based procedures. ”

In an interview, Trinh, who also studies health outcomes and patient safety, said the relationship between surgical volume and outcome is well established; that is, the more you do. the better you are. But while patients tend to shop around for high-volume surgeons when considering very complex procedures, like for cancer or heart surgery, that scrutiny doesn’t always carry over for simpler surgeries. “It’s something that people often don’t think about,” Trinh said, “but the same relationship [high volume equals better outcomes] applies to the less complex, same day procedures. Though the complications from vaginal mesh surgery may not be life threatening, erosions and fistulas, these things can make your recovery and quality of life miserable.”

Of course, Trinh said, it’s sometimes unrealistic for people to demand the very best, most experienced surgeon for every procedure. Continue reading

When A Burst Appendix Doesn’t Kill You: Big New Study Adds Data

An urgent laparoscopic appendectomy is performed aboard the nuclear-powered aircraft carrier USS Enterprise, in this undated photo. (U.S. Navy via Wikimedia Commons)

An urgent laparoscopic appendectomy is performed aboard the nuclear-powered aircraft carrier USS Enterprise, in this undated photo. (U.S. Navy via Wikimedia Commons)

If you’re a regular reader, you may have noticed that certain posts tend to dominate our most-popular list: on birth control and sex, on diet and exercise. Pretty predictable crowd-pleasers.

But one sleeper’s appearance on the list has repeatedly surprised us: “When A Burst Appendix Doesn’t Kill You.” Turns out, appendicitis is no lightning strike: It hits 300,000 Americans a year, one-tenth of adults over their lifetimes.

That 2012 post shared the story of Martha Little, who was then WBUR’s news director and who kept toiling away in the newsroom even though her appendix had burst — not because she was a hopeless workaholic, but because she was undergoing antibiotic treatment.

The post prompted dozens of edifying appendicitis stories in the comments section, and now a new study adds some helpful data. But first, the necessary background in the post, from Dr. Douglas Smink of Brigham and Women’s Hospital:

Twenty years ago, Dr. Smink said, surgeons would go in and operate on virtually all cases of appendicitis, whatever the level of inflammation. But research found that for a certain group of patients, it was better to wait. Now, even the “interval appendectomy” is becoming controversial; a newer school of thought holds that some patients may do best with antibiotics alone, no operation at all.

The problem right now, he said, is that there’s some data on the antibiotics-only strategy, but not enough to make clear which patients really need an appendectomy and which can get along without one. Patients who have a stone in the appendix, called an appendicolith, definitely need the organ removed, for example, but many other cases are not so clear cut. More research is needed, he said, to explore the effects of age, severity of illness and other factors on whether antibiotics-only treatment will work for a given patient.

Meanwhile, some studies also suggest that for many patients with uncomplicated appendicitis — the appendix still intact — antibiotic treatment alone may be enough as well.

Continue reading

How 3D-Printing Helped A Little Girl With A Rare Facial Defect

Check out this excellent story about a little girl named Violet born with a rare defect, a Tessier facial cleft, that left a fissure in her skull, and how 3D-printing is helping doctors take on these kinds of complicated surgeries. The piece is in today’s The New York Times and written by health reporter and CommonHealth contributor Karen Weintraub, who offers a little background:

Violet Pietrok was born nearly two years ago without a nose. Her eyes were set so far apart that her mom compared her vision to a bird of prey’s. There was a gap in the skull behind her forehead.

There was no question she would need drastic surgery to lead a normal life. But few surgeons have seen patients with problems as complex as Violet’s. Her parents, Alicia Taylor and Matt Pietrok, who live near Salem, Oregon, brought her to Boston Children’s Hospital, to Dr. John Meara, who had operated before on kids with Tessier facial clefts.

As part of Children’s Pediatric Simulator Program, Meara was able to get several 3D printed models made of Violet’s skull. By handling and slicing up the models, he got a better sense of what had gone wrong and how best to fix it.

Such 3D-printing is becoming more commonplace in complex surgeries, allowing doctors views and knowledge they can’t get on their screens.

Continue reading

The Checkup: Talking Back To Your Doctor

Welcome to the The Checkup. Our sixth episode “Talking Back to Your Doctor,” opens with a question: Why do so many of us find it so hellishly hard to speak freely with our doctors? What is it about a white coat that makes even normally assertive people clam up?

(To listen to The Checkup now, click on the arrow above; to download and listen later, press Download; and to get it through iTunes click here.)

We begin with the dramatic story of Alicair Peltonen, an administrative assistant diagnosed with a rare cancer who had to have a chunk the size of a baseball removed from her thigh. Throughout her medical saga, she found that she often had urgent questions echoing in her mind, but felt too inhibited to voice them. She set out to find out why. The Checkup

We speak with Dr. Jo Shapiro of Brigham and Women’s Hospital in Boston about what she calls “Conversation Deficit Disorder” among doctors. And we hear from Dr. Annie Brewster, who has special insight into doctor-patient communication because she’s both a practicing doctor and a multiple sclerosis patient who decided not to follow her doctor’s recommendations about taking a particular medication.

Each episode of the Checkup features a different topic—previous topics included college mental health, sex problems, the Insanity workout and vaccine issues.

This is the closing episode of our first season of The Checkup. Please tell us what you liked and disliked and what you want more of. Like CommonHealth on Facebook or drop a note to

We’ll keep you posted here on all our plans for future podcasts.

Are Young Women With Cancer In One Breast Needlessly Having The Other Removed?

Are young patients with cancer in one breast, driven by unfounded fears and anxiety, having the other breast removed unnecessarily?

That’s the troubling question implicit in this new survey of women 40 or younger who chose to undergo double mastectomies even though their cancer was only in one breast. The procedure, called contralateral prophylactic mastectomy (CPM), has increased “dramatically” in recent years, particularly among younger women, researchers report.

But evidence suggests that the removal of a healthy breast in a woman with cancer in only one breast does not improve survival rates.



Still, researchers from the Dana-Farber Cancer Institute and colleagues report that more and more young women with breast cancer are electing to remove their healthy breast to “avoid recurrence and improve survival.”

Specifically, the study found that among 123 women surveyed, 98 percent said they chose CPM to avoid getting cancer in the other breast and 94 percent said they did it to improve survival. (Also of note, 95 percent said they did it for a more nebulous but emotionally potent reason: “peace of mind.”)

If you’ve had breast cancer, or know anyone who has, it’s easy to see why such a subjective, non-data point like “peace of mind” might trump a more rational, just-the-facts approach to treatment. But this paper, published in the Annals of Internal Medicine, points to what it calls the “cognitive dissonance” between what women know to be the facts and what they actually do.

“Many women overestimate their risk for actual cancer in the unaffected breast,” the paper says, concluding that: “Interventions aimed at improving risk communication in an effort to promote evidence-based decision making is warranted.” Continue reading

Study: Despite Risk, OB’s Urge Ovary Removal With Hysterectomy

A new study by Massachusetts doctors underscores a common phenomenon in medicine: patients often get treatment advice that contradicts what may actually be best for them.

In this case, researchers found that “many OB/GYNs continue to advise pre-menopausal women to have their ovaries electively removed along with hysterectomies, despite indications that the benefits of retaining the ovaries may exceed risks of doing so, including ovarian cancer.”

doctor and patientThe study, co-authored by Drs. Oz Harmanli of Baystate Medical Center and Tufts University School of Medicine with Julia Shinnick, Keisha Jones, and Peter St. Marie, is summed up in the news release:

…one-third of OB/GYNs surveyed continue to recommend elective removal of the ovaries for hysterectomy candidates younger than 51 years old, and the majority recommend the procedure for hysterectomy candidates 51 to 65 years old. The procedure is seen as an effective way to head off ovarian cancer; however, the benefits of retaining the ovaries, mainly in the form of continued estrogen production and its effects on the body, may supersede any risks. The American Congress of Obstetricians and Gynecologists (ACOG) has made recommendations opposing elective ovary removal before menopause.

“We believe many women are electively having their ovaries removed based on recommendations from their doctors that may not be consistent with best practice,” said Dr. Harmanli, chief of Urogynecology and Pelvic Surgery at Baystate Medical Center. “Retaining the ovaries before menopause can confer cardiovascular, sexual and other benefits. Hormone therapy is not risk free and can’t always replace what’s lost with oophorectomy (ovary removal), and in this survey we see solid proof that the best advice is not always being given.”

Some researchers advise conservation of ovaries at the time of hysterectomy, based on some evidence that ovaries continue to help decrease mortality up to age 65. Another finding of this survey was that over 90% of OB/GYNs do not follow this advice. Continue reading

Consumer Reports Rates Surgery; Hospitals Push Back

We, patients, need user-friendly ways to answer this question: Where’s the best place to go for a knee replacement, or cardiac care, or to deliver a baby?

It is virtually impossible to find an answer even though hospitals have reams of information about how often patients recover smoothly and how often they suffer infections, complications or even die after surgery.

A few groups are stepping into the void. The latest issue of Consumer Reports rates hospitals in Massachusetts, and across the country, on surgery. The “overall” scores surprised me.

From Consumer Reports' “Your Safer-Surgery Survival Guide”

From Consumer Reports’ “Your Safer-Surgery Survival Guide”

Carney Hospital at the top is hardly a magnet for patients needing surgery in the Boston area. Some hospitals that are have the lowest overall ratings.

I called Mass General, where the hospital’s senior VP for quality and safety, Dr. Elizabeth Mort, praised the goal of giving patients more information about the quality of care. But she says Consumer Reports’ methods have so many flaws that these ratings “do the patient a disservice.”

The ratings, Mort says, don’t accurately take into account:

– how sick the patient was when he or she came in for surgery or the severity of their disease
– how many other conditions the patient may have
– how many complications actually occurred

The ratings are also misleading, Mort says, because they pool different types of procedures in single category. For example, they pool many prostate procedures, even though some hospitals perform very specialized and difficult surgeries and some hospitals only perform the most basic operations.

Consumer Reports’ ratings are based on two factors: how often patients died in the hospital following surgery and how often they had an extended stay, which is often a sign there were complications. Researchers combed through Medicare billing records. Consumer Reports doesn’t have medical reports that would allow it to adjust for the issues Mort mentioned above.

“That’s a little bit of the point,” says Doris Peter, with Consumer Reports Health Ratings Center, “that clinical data is not widely available to the public and we can’t base our ratings on clinical data if it’s not made available.”

Dr. John Santa, medical director of Consumer Reports Health, says in the magazine that while the ratings aren’t perfect, “we think they’re an important step in giving patients information they need to make an informed choice.” And, he adds, “we hope that by highlighting performance differences, we can motivate hospitals to improve.”

The Massachusetts Hospital Association (MHA) says it supports “greater transparency regarding quality and financial data to better inform the public,” but that “Consumer Reports’(CR) continued efforts to rate US hospitals result in greater confusion rather than clarity with an oversimplification of this extremely complex and important subject.”
Continue reading

100 Days Later, Marathon Bombing Survivor Leaves Rehab

BOSTON — After 16 surgeries that included 49 procedures, Boston Marathon bombing survivor Marc Fucarile, of Stoneham, is going home.

Police rushed the 34-year-old to Massachusetts General Hospital 100 days ago. His skin still smoldered. Blood gushed out of both legs.

“His injuries include amputation of his right leg above his knee, multiple fractures of his left leg and foot, burn injuries to his legs, trunk, back and pelvis,” said Dr. Jeffrey Schneider, one of Fucarile’s physicians after he moved to Spaulding Rehabilitation Hospital. The list also includes a fractured spine, ruptured eardrums and multiple shrapnel wounds to Fucarile’s extremities and torso.

Marathon bombing victim Marc Fucarile speaks before departing Spaulding Rehab Hospital Wednesday. (Martha Bebinger/WBUR)

Marathon bombing victim Marc Fucarile speaks before departing Spaulding Rehab Hospital Wednesday. (Martha Bebinger/WBUR)

“Wow, I forgot how much it really was,” Fucarile said Wednesday, shaking his head.

When he arrived at Spaulding, Fucarile couldn’t even sit up in bed for any length of time. On Wednesday, he hobbled on crutches into the hospital lobby. Spaulding staff and Fucarile’s family members applauded. Fucarile smiled, but sobered as he recounted his ordeal.

“It’s just been tough, real tough, especially when my son’s home sick, Jen’s not sleeping,” he said. “At times I just want to check out.”

Fucarile glanced at his 5-year-old son Gavin and his fiancée Jen Regan. Their support, he said — along with all the cards taped to his wall, donations and hand-knit blankets he’s been sleeping under — have helped him through many nights of pain and motivated him to stretch new skin and shriveled muscles.

“I know that I have the rest of my life, thanks to the people who were there that day who helped me and saved me,” he said. “I’d go through 100 more procedures as long as I can be there to go home with him.”

Gavin smiled and giggled through most of Fucarile’s press conference. Regan, Fucarile’s longtime companion, joked that she’s been getting the house ready for his return. “We got a frontload dryer and washer so he can do the laundry in his wheelchair.” Continue reading

Questioning Ovarian Cancer: Why Such A High Fatality Rate?

Photo Credit: Wikimedia Commons

Photo Credit: Wikimedia Commons

There is tragic news coming from the entertainment world today.  Pierce Brosnan announced that his daughter, Charlotte, age 41, died of ovarian cancer three days ago.  This is the same illness that took her mother’s life in 1991 when she, like her daughter, was in her early 40s.

Angelina Jolie – who underwent a preventative double mastectomy earlier this year —  lost her mother to ovarian cancer in 2007.

According to the CDC, ovarian cancer is the second most common gynecological cancer, after uterine cancer, and it’s the cause of more deaths than any other gynecological cancer.

The numbers look like this: ovarian cancer kills 15,000 women and approximately 22,000 new cases are diagnosed annually in the US.  Approximately 90% of cases occur in women over 40 and the majority of diagnoses are given to women aged 60 years or older.   According the the American Cancer society, the survival rate for patients who live for five years after they are diagnosed with ovarian cancer is 44%.

Unlike breast or cervical cancer, there is no reliable screening measure for ovarian cancer.  Once it is detected, the first line treatment option is surgery.

Earlier this year, The New York Times reported on a study that suggested the high fatality rate amongst ovarian cancer patients is attributable to widespread deficiencies in the typical treatment most women receive. The article reports that only a third of women with ovarian cancer receive “best practice” treatment, which the study says, is a complicated and intensive operation performed by a highly specialized surgeon.

Here is an excerpt from the article:

Cancer specialists around the country say the main reason for the poor care is that most women are treated by doctors and hospitals that see few cases of the disease and lack expertise in the complex surgery and chemotherapy that can prolong life.

If we could just make sure that women get to the people who are trained to take care of them, the impact would be much greater than that of any new chemotherapy drug or biological agent,” Continue reading

Study: Common Surgery For Prolapse Fails Nearly 1 Out of 3 Women

We’ve written a lot about the scary complications associated with vaginal mesh, synthetic devices that are surgically implanted to treat women suffering from prolapse. This condition, which afflicts millions of women after childbirth or as they age, occurs when stretched or weakened pelvic-area tissues give way, allowing the bladder or other organs to sag or bulge into the vagina.

Now, adding to the mounting data on the potential risks of prolapse surgery in general, a new study in the Journal of the American Medical Association finds that a common surgical treatment for prolapse — one considered the “gold standard” involving abdominal surgery — fails nearly 1 out of 3 women.

So why does prolapse surgery matter? As the JAMA study authors note, nearly 1 in 4 woman have at least one pelvic floor condition and “more than 225,000 surgeries are performed annually in the United States for pelvic organ prolapse.” So, any woman considering this surgery should be aware of the “long-term risks of mesh or suture erosion.” Continue reading