Blog > April 2012

Monthly Archives: April 2012

Men Over Age 50 are being Victimized by Overly Agressive Surgery!

Sources:  Duke Medical School, International Journal of Radiation Oncology, Biology, Physics, Vol. 82, Issue 5, 1 April 2012, p. 781; NCCN Guidelines for Prostate Cancer; National Institute for Health & Clinical Excellence; James Buchanan Brady Institute at Johns Hopkins Memorial Hospital; Sloan Kettering Memorial Hospital 

Editorial

After 30 years of Medical Malpractice Litigation, I have come to recognize that medicine has patterns of treatments falling in and out of vogue every 10-20 years.  Over 20 years ago, women were almost routinely given hysterectomies for a wide range of post menopausal symptoms including bleeding and cramping.  Women with Breast Cancer invariably underwent radical mastectomy, the standard of care in the 1980′s.  Did our Mothers, Sisters, Wives and Girlfriends require these surgeries?  The emergence of a number of non-surgical treatment options that have been just as effective lead one to question the wisdom of the times.  I used to think it was a function of women utilizing medical services 3x more than men or that it was simply bad luck to have been born a woman in modern society.  Perhaps there was simply way too much money involved in surgeries, operative times, anesthesia times and inpatient postoperative stays for the US healthcare system to slow itself down and reflect?

Lately, a good portion of my practice, has focused upon men and their healthcare experiences.  It has been my observation that there is a significant amount of prostate surgery, stemming from the overly agressive approach to prostate cancer treatment.  All too often surgeries are scheduled for men with prostate cancer at such an early stage that it does not represent a life-threatening condition.  Add to this the reports of misread biopsies, mis applied PSA scores and overly read scans and the results are a staggering amount of radical prostatectomies.  Of course there are those who will blame the Medical Malpractice trial lawyers for creating a climate of fear among physicians, leading them to suggest surgery.  This argument makes little sense.  Cancer is a lot like being pregnant, either you’re positive or you aren’t.  And why is there a disproportionate amount of surgery in the male 50 to 80 years of age group?  If one lives long enough, they will get prostate cancer -currently affecting 1 out of 6 men.  This is actually more prevalent than breast cancer, which affects 1 out of 8 women.  However, studies following autopsy have demonstrated that even where prostate cancer is present, it has not been the cause of death in 90% of men.  Prostate cancer tends to be slow growing (indolent) and non-recurrent. 

So why all the surgery?  And what does this mean for men age 50 and older?  First, be very careful with your choice of a Urologist.  A competent urologist is most likely to obtain a good biopsy sample of the prostate.  Be aware that the Pathologist who interprets the biopsied tissue may make an error as well leading to our Second recommendation.  Get a second opinion.  In most cases you will basically feel healthy.  Make sure you aren’t being misdiagnosed or overly diagnosed.  Look at the stock market lately.  The company which pioneered robotic sugery, originally for women and now for the prostate, is at an all time high.  The Global Market for surgical robotics is expected to exceed 5 billion by 2015.  Most metropolitan and now suburban hospitals have invested considerable amounts of capital in robotic and minimally invasive surgeries to bring more patients through their doors and into their operating rooms.  This is not a train that is easily derailed. 

I am certainly not against new technology and constantly push hospitals and physicians to move toward more state-of-the-art practices in the cases I bring on behalf of my clients.  I am simply warning that not all surgeries are indicated and that prostatectomy -no matter how robotic or “minimally-invasive” involves the disconnection and reconnection of vital structures and nerve endings which can and does result in temporary (and sometimes permanent) loss of sensation, erectile dysfunction and incontinence.  Consider your options carefully and make well informed choices.

Have you or a loved one been diagnosed and treated for prostate cancer?  Contact the Lewis Law Firm for a free consultation.

Posted by: Gayle R. Lewis, Esquire

Physican Group Advocates Less Testing for Patients.

Sources:  Choosing Wisely.org (An Initiative of the American Board of Internal Medicine Foundation) Press Release; NY Times Health Blog

Under the “educational initiative” of Choosing Wisely, led by the American Board of Internal Medicine Foundation and involving 8 other specialty boards are recommending less routine testing for their patients.  The thought process is that unnecessary testing is costly to the health care system and may actually harm patients.  The move comes, not surprisingly, as insurance companies and third party payors (The US Government) are looking to shift costs back to hospitals and physicians.  If there is any doubt as to the financial focus, the initiative is openly partnering with Consumer Reports on the initiative.  The lists are presented as a series of questions (which will likely follow as practice recommendations) that patients and their physicians should question with suggested answers, including:

Q.  Do patients need brain imaging scans (CT or MRI) after fainting, also known as simple syncope?  A.  Probably not.  Research has shown that, with no evidence of seizure or other neurologic symptoms during an exam, patient outcomes are not improved with brain imaging studies.  (American College of Physicians) 

Q.  Do patients need stress imaging tests for annual checkups?  A.  Not if you are an otherwise healthy adult without cardiac symptoms.  These tests rarely result in any meaningful change in patient management.  (American College of Cardiology)

Q.  Should patients going into outpatient surgery receive a chest x-ray beforehand?  A.  If the patient has an unremarkable history and physical exam, then no. Most of the time these images will not result in a change in management and has not been shown to improve patient outcomes.  (American College of Radiology) 

Q.  Do patients need a CT scan or antibiotics for chronic sinusitis?  A.  Most acute rhinosinusitis resolves without treatment in two weeks and when uncomplicated is generally diagnosed clinically and does not require a sinus CT scan or other imaging.  (American Academy of Allegry, Asthma & Immunology)

Q.  Should dialysis patients who have limited life expectancies and no signs or symptoms of cancer get routine cancer screening tests?   A.  These tests do not improve survival in dialysis patients with limited life expectancies, and can cause false positives which might lead to harm, over treatment and unnecessary stress.  (American Society of Nephrology)

The Organizations, representing some 375,000 physicians, who released lists of questions with Choosing Wisely are:  The American Academy of Allergy, Asthma & Immunology; The American Academy of Family Physicians; The American College of Cardiology; The American College of Physicians; The American College of Radiology; The American Gastroenterological Association; The American Society of Clinical Oncology; The American Society of Nephrology; and The American Society of Nuclear Cardiology.

From the press Release:  “Today these societies have shown tremendous leadership in starting a long overdue and important conversation between physicians and patients about what care is really needed,” said Christine K. Cassel, M.D., president and CEO of the ABIM Foundation. “Physicians, working together with patients, can help ensure the right care is delivered at the right time for the right patient. We hope the lists released today kick off important conversations between patients and their physicians to help them choose wisely about their health care.”  Consumer Reports (CR) – the world’s largest independent product-testing organization – is working with the ABIM Foundation and the specialty societies to lead the effort.”

Even specialists such as oncologists (cancer doctors) are being urged to cut back on scans for patients with early stage breast and prostate cancers that are not likely to spread rapidly.  Patient advocacy groups and other specialists have expressed caution, warning that the directives could be misinterpreted and applied too broadly at the expense of patients.

If you or a loved one have been harmed by poor medical care, contact the Lewis Law Firm for a free consultation and opinion.  The Lewis Law Firm is dedicated to improving the quality of health care delivery in Pennsylvania and New Jersey.

Posted by:  Gayle R. Lewis, Esquire

New Jersey Same Day Surgery Center’s Reviewed

Source:  NJ Department of Health and Senior Services (NJ DHSS)

What are Ambulatory Surgery Centers?
Ambulatory Surgery Centers or “Same Day Surgery Centers” are facilities where patients can undergo certain types of surgery or medical procedures, recover and go home the same day. Eye, knee and shoulder surgery, cosmetic surgery, and procedures such as colonoscopy screening for colon cancer are examples of services these centers provide.

 

How many Ambulatory Surgery Centers are there in New Jersey?
There are 133 DHSS-licensed centers in the state. Another 116, though not DHSS-licensed, are certified by the federal Centers for Medicare and Medicaid Services as meeting CMS standards of care. Many other centers come under the authority of the New Jersey state Board of Medical Examiners, which regulates private physician practice. 

Patient Safety in New Jersey
DHSS inspects licensed ambulatory surgery centers every three years.  Hospitals and ambulatory surgery centers must report to New Jersey’s confidential Patient Safety Reporting System when a serious preventable adverse event occurs. Facilities must conduct a root cause analysis to find the underlying causes of the medical error, and develop and implement a plan to prevent future errors.  DHSS, working in conjunction with the Centers for Medicare and Medicaid Services, temporarily curtailed admissions at some ambulatory surgery centers for deficiencies in meeting standards related to infection control, safety, sanitation, medication control, patient safety and other issues. Each of these centers was allowed to reopen after correcting the problems identified.

To learn more, visit the NJ DHSS Patient Safety web site.  The Annual Reports contain data on errors and their underlying causes, and track statewide trends in the effort to improve patient safety.  By way of example, from the 2009 survey the following issues continue to be problematic:

 Falls (preventable) are the largest recurring category of issues in NJ Hospitals and Same Day Surgery Centers

 Pressure Ulcers and “Care Management Other” continue to be the next largest subcategories

 There has been an increase in the number of reportable device malfunctions, wrong patient/wrong site/wrong procedure events and suicide/attempted suicide in 2009.

 The number of retained foreigh objects (RFOs) (things left inside of patients during surgery) remained roughly constant from 2008 to 2009, 27 to 25 RFOs.

If you or a loved one were injured at a New Jersey Hospital or Same Day Surgery Center contact the Lewis Law Firm for a free consultation and opinion.  The Lewis Law Firm is committed to improving the quality of medical and hospital care for New Jersey residents.

Posted by: Gayle R. Lewis, Esquire

Prostate Cancer -Get the Facts

Sources: US Centers for Disease Control & Prevention (CDC), Cancer.org

Other than skin cancer, prostate cancer is the most common cancer Amercian men will face.  1 in 6 men will be diagnosed with prostate cancer.  The American Cancer Society 2012 estimates for prostate cancer in the United States are:

  • 241,740 new cases of prostate cancer will be diagnosed
  • 28,170 men will die of prostate cancer

The average age at the time of diagnosis is about 67.  Prostate cancer is the second leading cause of cancer death in men, behind only lung cancer.  1 in 36 men will die from prostate cancer.  However a good percentage of men diagnosed with prostate cancer will survive:

  • The relative 5-year survival rate is nearly 100%
  • The relative 10-year survival rate is 98%
  • The 15-year relative survival rate is 91%

A note on survival rates:  The 5-year survival rate refers to the percentage of patients who live at least 5 years after their cancer is diagnosed.  Some will live longer and some will only live 5 more years after a diagnosis. Keep in mind that 5-year survival rates are based on patients diagnosed and first treated more than 5 years ago, and 10-year survival rates are based on patients diagnosed more than 10 years ago. Modern methods of detection and treatment mean that many prostate cancers are now found earlier and can be treated more effectively. If you are diagnosed this year, your outlook may be better than the numbers reported above.  These survival rates are based on previous outcomes of large numbers of men who had the disease, but they cannot predict what will happen in any particular man’s case.

Risk Factors

Not all men with these risk factors will develop prostate cancers, but more will than not.

  • Age -More thatn 65% of prostate cancer diagnoses are made over age 65
  • Race -African Amercian Males are 60% more likely to be diagnosed than Caucausians and have 2.5x more mortality.  Asian men (living in Asia) have the lowest risk
  • Genetics -Family history is important.  Having a father or brother with prostate cancer increases the risk 2x
  • Geography -Men who live North of Philadephia PA (40 degrees latitute) have the highest risk of death from prostate cancer.  The theory is that inadequate sunlight for 3 months every year decreases vitamin D
  • Smoking -While a risk factor for ALL cancers, smoking has been linked with more aggressive prostate cancer
  • Diet -A lack of leafy green vegetables is associated with more aggressive prostate cancer
  • BMI (Body Mass Index) -Obesity is linked with more aggressive prostate cancer

Signs of Prostate Cancer

These are just some of the symptoms associated with prostate cancer.  Some men have no symptoms at all : Weak or interrupted flow of urine; Frequent urination (especially at night); Trouble urinating; Pain or burning during urination; Blood in the urine or semen; Pain in the back, hips, or pelvis; Painful ejaculation; Elevated PSA (prostate specific antigen).

Treatment of Prostate Cancer

Although treatment options vary depending upon the stage of prostate cancer, these are the most common current treatment options for men:

  • Watchful waiting -That’s correct.  The most common treatment is doing nothing but waiting until the cancer reveals itself on testing or scanning
  • Radical prostatectomy -Surgery to remove the prostate, with newer robotic guidance it may be possible to remove the prostate without damaging nerves that are necessary for an erection
  • External-beam radiation therapy -Directed to the prostate and any areas of potential spread
  • Implant radiation therapy -With radioactive “seeds”
  • High-intensity focused ultrasound -Designed to break up the tumor to facilitate removal
  • Experimental treatment

If you or a loved one have been diagnosed with prostate cancer and you believe there was a delay in the diagnosis, contact the Lewis Law Firm for a free consultation and opinion.  The Lewis Law Firm has a history of litigating cases of delayed diagnosis of prostate cancer.

Posted by:  David M. Schwadron, Esquire

How Healthy is your County in New Jersey?

Sources:  The US Centers for Disease Control & Prevention (CDC), the Dartmouth Health Atlas, the U.S. Census Bureau

The 2012 County Health Rankings report, the third annual, is out today and measures each of the 3,005 counties in the U.S.  The report, which draws on data from the CDC, the Dartmouth Health Atlas, the U.S. Census Bureau and other sources, is user-friendly and free.  The project, is a collaboration of the University of Wisconsin Population Health Institute and the Robert Wood Johnson Foundation.  Their aim is to help local leaders and residents see not only where they rank on factors that determine health, but also specific ways to improve.  So how healthy is your county?

 

 

The Lewis Law Firm is committed to doing our part to improve the quality of health and healthcare delivery in your county.  If you or a loved one were injured by medical malpractice, please contact the Lewis Law Firm for a free consultation.

Posted by: Gayle R. Lewis, Esquire

How healthy is your County in Pennsylvania?

Sources:  The US Centers for Disease Control & Prevention (CDC), the Dartmouth Health Atlas, the U.S. Census Bureau

The 2012 County Health Rankings report, the third annual, is out today and measures each of the 3,005 counties in the U.S.  The report, which draws on data from the CDC, the Dartmouth Health Atlas, the U.S. Census Bureau and other sources, is user-friendly and free.  The project, is a collaboration of the University of Wisconsin Population Health Institute and the Robert Wood Johnson Foundation.  Their aim is to help local leaders and residents see not only where they rank on factors that determine health, but also specific ways to improve.  So how healthy is your county?

 

 

The Lewis Law Firm is committed to doing our part to improve the quality of health and healthcare delivery in your county.  If you or a loved one were injured by medical malpractice, please contact the Lewis Law Firm for a free consultation.

Posted by: Gayle R. Lewis, Esquire

A Cheap Plastic Ring May Prevent Premature Birth

Sources:  The Lancet online, BBC Health

They aren’t entirely new, however, in one of the first radomised and controlled studies, women with a short cervix (identified by transvaginal ultrasound at 20-23 weeks) had a simple silicon pessary device inserted to determine if this might reduce the risk of preterm labor.

 A Brief Background

Being born prematurely (before 34 weeks) during pregnancy is linked to a host of health problems, including:  breathing problems; blindness or poor vision; infection; and, death.  Over 13 million babies are  born prematurely every year.  One reason for premature births is a short cervix, defined as a length of 25 mm or less.  Physiologically, a short cervix does not accomodate a growing baby to term.

The Study

The Pesario Cervical para Evitar Prematuridad (PECEP) trial followed 11,875 pregant women (aged 18-43) in five hospitals in Spain. The women were randomly assigned to have a cervical pessary placed or to continue their pregnancy without one.  Unlike placebo studies, the control and study groups were known.

Results

Spontaneous delivery before 34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group.  How significantly?  In the group of women without the pessary, 27% of babies were born prematurely. In the group with the pessary. the rate of premature birth was 6%.  No serious adverse effects with the use of a cervical pessary were reported.

Maria Goya, one of the researchers at the Vall d’Hebron Hospital, said: “Placement of a pessary is an affordable procedure, non-invasive, and easy to insert and remove as required.”  Prof Steve Thornton of the University of Exeter, a spokesman for the Royal College of Obstetricians and Gynaecologists, echoed the theme, adding, ”The difference in the two groups is pretty amazing.”  Drs Steve Caritis and Hyagriv Simhan, of the Magee Women’s Hospital in Pittsburgh, said the findings had “renewed enthusiasm for the cervix as a therapeutic target” in preventing premature births.

Of course, the usual caveats apply, it is thought that only a small portion of women have a short cervix and “more studies are needed.”

If you or a loved one had a child born prematurely and you beleive that you were not provided with appropriate obstetrical care, contact the Lewis Law Firm for a free consultation.  The Lewis Law Firm is committed to the health of women and children.

Posted by: Gayle R. Lewis, Esquire

Fosomax and Fractures

Sources:  US Food & Drug Administration; Journal of Oral & Maxillofacial Surgeons

A recent report of Oral & Maxillofacial Surgeons focuses upon the link between bisphosphonates (Fosomax, Boniva, Actonel, Reclast) and osteonecrosis of the jaw.  Osteonecrosis of the jaw is a disease in which bone tissue in the jaw does not heal after minor traumas, such as tooth extractions by a dentist.  The delayed healing causes the  bone of the jaw to become exposed leading  to infections often requiring long-term antibiotic therapy and surgery to remove the dead and dying bone tissue.   Other patients experience actual breaking of the jaw on tooth remocal.  Patients using Fosamax and other bisphosphonates should try to avoid tooth extractions and other major dental work while taking these medications.

The FDA announced as early as October of 2010 that bisphosphonates, medications to treat osteoporosis (a condition which makes bones brittle) may actually cause fractures of the femur (thigh bone). 

Bisophosphonates are drugs which are currently prescribed to more than half a million people diagnosed with osteoporosis.  Their prolonged use may be responsible for making bones more brittle. These drugs operate by slowing down the process of osteoclast cells which break down bone and replace it -a natural process.  The longer this natural process is delayed, the older the cells which make up the bone actually become.  Accordingly, the replacement bone is made up of old bone cells which are more brittle and more subject to fracture with limited or no trauma.  Those taking Fosomax for more than 3 years appear to be at most risk for low-energy femur fractures.

Merck, the manufacturer of Fosamax (Alendronate), has largely denied the claims currently the subject of several class action lawsuits, although their labeling has been revised consistent with this information. 

If you or a loved one are taking Fosomax, Boniva, Actonel, Reclast or any other osteoporosis drug and you have experienced a low-energy femur fracture or osteonecrosis of the jaw, contact the Lewis Law Firm to determine if you have a case.  Our consultation and initial opinion are free.

Posted by: David M. Schwadron, Esquire

Transvaginal Mesh -A Safety Concern for Patients

Source:  US Food and Drug Administration (FDA)

The FDA has issued an update warning doctors and patients of the dangers of transvaginal mesh placement.  This follows years of  dramatic increases in reports of adverse events over the use of surgical mesh for the transvaginal repair of POP (pelvic organ prolapse).  POP occurs when the internal structures that support the pelvic organs -the bladder, uterus, and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina.  Women with POP often experience pelvic discomfort; disruption of their sexual, urinary, and bowel functions; and an overall reduction in their quality of life.

The FDA previously suggested (in a 2008 report) that serious complications associated with surgical mesh for POP procedures and stress urinary incontinence were “rare.”  In July of 2011, the FDA reversed their position on this issue stating that there was no clear evidence that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and actually may expose patients to “greater risk.”  It appears the FDA is maintaining their latest position.

“There are clear risks associated with the transvaginal placement of mesh to treat POP,” according to William Maisel, MD, MPH, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”

An FDA review of adverse events of all urogynecologic surgical mesh products from January 2005 to December 2010 identified 3979 reports of injury, death, and malfunction. There were 5x as many reports of adverse events associated with transvaginal mesh from January 1, 2008, to December 31, 2010 than in the previous 3 years, according to the FDA.

Erosion of mesh through the vagina and mesh contraction may lead to severe pelvic pain, painful sexual intercourse, or an inability to engage in sexual intercourse. infection and urinary and fecal incontinence.  The FDA cleared the first surgical mesh product specifically for use in POP in 2002.  Mesh manufacturers include: American Medical Systems; Bard; Boston Scientific; Johnson & Johnson and Caldera.

If you or a loved one underwent vaginal mesh implantation and are experiencing complications, contact the Lewis Law Firm to determine if you have a case against the manufacturer or the doctor who performed the procedure.  Our free consultation and initial opinion may assist you.

Posted by:  Gayle R. Lewis, Esquire

Breast Cancer Screening Questioned

Sources:  Harvard School of Public Health, Annals of Internal Medicine online, BBC Health News

Harvard School of Public Health (HSPH) research suggests that routine mammography screening, the current essential tool in detecting early breast cancers, may lead to a significant amount of overdiagnosis of disease that would otherwise have proved harmless.

The researchers analyzed data from 39,888 women with invasive breast cancer in Norway, 7,793 of whom were diagnosed during the 10-year rollout of the Norwegian Breast Cancer Screening Program, which began in 1996, (women ages 50 through 69).  Given the size of the study, researchers were able to compare the number of breast cancer cases in women who had been offered screening with those not offered screening.  The working theory was if mammography is beneficial, it would lead to a decrease in late-stage breast cancer cases, or early detection prevents late-stage disease.

But the researchers did not find a reduction in late-stage disease in women who’d been offered screening.   Instead, there was a substantial amount of overdiagnosis.  Of 7,793 women diagnosed with breast cancer through participation in the screening program, 15% to 25% were overdiagnosed (1,169 - 1,948 women).  Accordingly, for every 2,500 women undergoing early screening, 2,470 to 2,474 will never be diagnosed with breast cancer and 2,499 will never die from breast cancer.  The projected result is that for the 1 death prevented, 6 to 10 women will be overdiagnosed, and treated with surgery, radiation therapy, and possibly chemotherapy without any benefit.

“Mammography might not be appropriate for use in breast cancer screening because it cannot distinguish between progressive and non-progressive cancer,” said lead author Mette Kalager, a visiting scientist at HSPH and a researcher at the Telemark Hospital in Norway.   Most women in the U.S. begin having annual mammograms in their 40s or 50s. 

Dr Julie Sharp, Cancer Research UK’s senior science information manager, was quoted as saying: “Women need more accurate, evidence-based and clear information to be able to make an informed choice about breast screening. The decision whether to be screened is a personal one and that decision should be made with all of the potential harms and benefits fully explained.  “Until we have the results of the review, Cancer Research UK’s position is that we remain supportive of breast screening.”

If nothing else, the new findings suggest that women should be well-informed not only about the potential benefit from mammography, but also about its possible harms—including mental distress, biopsies, surgeries, or chemotherapy and hormone treatments for disease that would never have caused symptoms.

For more information, see: “Overdiagnosis of Invasive Breast Cancer Due to Mammography Screening: Results From the Norwegian Screening Program,” Mette Kalager, Hans-Olov Adami, Michael Bretthauer, Rulla Tamimi, Annals of Internal Medicine, online April 2, 2012.

If you or a loved one have been diagnosed with breast cancer which could have been found earlier, contact the Lewis Law Firm www.attorneylewis.com to determine if you have a medical malpractice claim.  The Lewis Law Firm has a long history of representing breast cancer patients and their family members in Pennsylvania and New Jersey.

Posted by: Gayle R. Lewis, Esquire

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