About two million American men undergo transrectal biopsies each year to diagnose prostate cancer or to monitor low-risk and favorable intermediate-risk prostate cancers for active surveillance (AS).
Men on AS, like me, who have undergone routine transrectal biopsies may be warned that we face a 1-3% risk for sepsis infections in which nasty microbes from the rectum are spread to the bloodstream and wreak havoc. Many are not warned at all.
But it gets worse: A number of these men die or suffer disability from sepsis from transrectal biopsies, according to Richard Szabo, MD, a clinical associate professor of urology at the University of California Irvine.
Based on Norwegian figures, one in 1,000 men die from transrectal biopsies. This translates to roughly 2,000 American men per year, according to Truls Bjerklund Johansen, MD, a urology researcher at Oslo University Hospital.
The use of powerful antibiotics likely has kept the death rate down but portends long-term danger as antibiotic resistance grows and is expected to cause an additional death toll.
The True Toll of Transrectal Biopsies
The old maxim holds that doctors bury their mistakes. In the case of deaths by transrectal biopsies, mistakes often may be buried under a misleading cause listed on death certificates. Doctors don't often link deaths from septic shock to transrectal biopsies performed a few days earlier.
"When we fill out the death certificate, the cause of death is sepsis, the cause of sepsis is UTI [urinary tract infections], but no one considers the cause of the UTI," said Matthew Allaway, DO, a Cumberland, Maryland urologist and inventor of a new device that is causing a sea change in transperineal biopsies.
"Patients are beginning to wake up to the reality, but historically, since TP [transperineal] biopsy is relatively unknown to patients, they just figure this is the reality we must face," said Allaway. "Now that TP biopsy is gaining traction, patients are beginning to question how the biopsy is performed. No one is tracking death after prostate biopsy, they're only tracking death after the infection."
The severe consequences of sepsis reported after transrectal prostate biopsies include death or disability from hemorrhagic cerebellar infarction, gangrene requiring amputation of limbs, bacterial meningitis, spinal cord abscess, bacterial infection of the heart, catastrophic bleeding due to sepsis-induced loss of platelets, diffuse intravascular coagulation (uncontrolled bleeding and clotting due to loss of clotting factors), renal failure requiring dialysis, and fatal rectal abscess, according to Szabo. (Szabo has published a new literature review and analysis of 11,999 cases of "free-hand" transperineal prostate biopsy under local anesthesia.)
Alternative Techniques
Increasing numbers of urologists are adopting transperineal biopsies because the technique simply avoids putting the biopsy needle through the contaminated rectal wall. Szabo found that the new approach is so safe that prophylactic antibiotics may not be necessary.
As a patient who has undergone six transrectal biopsies in the past ten years, I heard about the risks, shrugged my shoulders, and bit the bullet, figuring the risk was the price for being on AS, monitoring your cancer closely, and avoiding radical prostatectomies with risks of impotence and incontinence. But over the years, I became increasingly resistant to transrectal biopsies and swore I would never have another.
The threat of danger from transrectal biopsies is real. I previously wrote about the hell Ferdinand "Ferd" Becker Jr., MD, a now-retired facial plastic surgeon from New Orleans, went through from sepsis contracted from a routine transrectal biopsy.
Six days after undergoing a biopsy, on Easter Sunday 2009, Becker spiked a fever of 103.5 degrees, accompanied by chills, fever, and delirium. Strong antibiotics saved his life. But not everyone is as lucky.
Becker subsequently underwent two uneventful transperineal biopsies by a radiologist in the bore of an MRI at Brigham and Women's Hospital in Boston.
The transperineal approach involves the insertion of biopsy needles in the skin between the scrotum and the rectum to drastically decrease the chances of infection. The infection rate at Brigham and Women's is a low 0.5%.
Sepsis rates after transrectal biopsies have experienced a fourfold increase over the past 25 years with the increases in antimicrobial resistance, Szabo said. This problem is expected to grow unless things change.
Becker's case and the other undetected cases are a call for urologists to re-evaluate what they are doing with transrectal biopsies and for men to question their urologists about biopsies and antibiotic use.
Personally, I have said for years if I ever have another biopsy, it would not be a transrectal biopsy. I don't plan to undergo them anymore. Luckily, my urologist recently agreed to use multi-parametric MRI to monitor me, but he has just been trained in the new PrecisionPoint transperineal procedure that can be performed in the office under local anesthesia and sometimes intravenous sedation.
Allaway is the founder and president of Perineologic, a start-up that developed the PrecisionPoint Transperineal Access System needle guide for transperineal biopsies that helps the urologist guide the biopsy needle to the prostate in conjunction with an ultrasound probe placed in the rectum. This is not intended as an infomercial because there are a couple of other ways to perform transperineal procedures. But Allaway's device may go down as urology's version of the astrolabe, the revolutionary navigation tool invented in the late 15th Century by an astronomer ancestor of mine.
Doctors have to be trained to use the disposable needle guide, which adds a cost of a little over $200 per procedure. But Szabo calculated that the cost in the U.S. of hospitalization for sepsis resulting from transrectal biopsy ranges from $9,000 to $19,000 per case. Assuming the 2% rate of post-biopsy sepsis quoted by the American Urological Association (AUA), this totals $342 million to $750 million per year. Calculated on a per-biopsy basis, this comes to $173 to $382 for each transrectal biopsy. This avoidable transrectal tax is borne by Medicare, private insurers, and self-insured patients.
These figures do not include emergency department visits for post-biopsy rectal bleeding (2.5%) resulting from the transrectal needle piercing hemorrhoids and other blood vessels in the rectal wall.
The new transperineal technique is so far only used by a small percentage of American urologists, but the technique is rapidly being accepted in some hospitals in Europe. Meanwhile, millions of American men continue to undergo transrectal biopsies at their own risk.
Misunderstood Risks of Transrectal Biopsies
Why are men and their doctors seemingly oblivious to the dangers of sepsis from transrectal biopsies?
Urologists who are honest with themselves will recognize that on average, every two to three years one of their patients will find himself in deep shit with sepsis from a "transfecal biopsy," a sarcastic but accurate term critics use to describe the transrectal approach.
I have talked to several doctors who have been shaken to the core by their transrectal misadventures.
Rick Popert, MB MS, FRCS (Urol), is a self-described "prostatologist" at Guy's Hospital, a National Health Service facility in London. He gave up the transfecal approach (he prefers this term) in 2006 when one of his patients, a vital man who literally climbed mountains as a hobby, nearly died from sepsis caused by the transrectal procedure. In 2017, Guy's Hospital stopped all transrectal biopsies and introduced the PrecisionPoint. By March 2019, all six of the hospitals in the South East London Cancer Network, a population of over 1.5 million, stopped transrectal ultrasound (TRUS) biopsies and converted to the transperineal approach.
Popert noted that another advantage of transperineal biopsies is that urologists find more cancer – the goal after all – because they have easy access to the anterior region of the prostate, where many prostate cancers reside. Transrectal biopsies cannot readily reach the anterior region.
Szabo described how several years ago, one of his transrectal biopsy patients had a sepsis-induced brain abscess that resulted in paralysis, loss of speech, and incontinence that put him under 24-hour care by his wife. The horror. All that for a semi-elective screening prostate biopsy.
An International Movement Toward Transperineal Biopsies
In November 2018, Norwegian doctors came clean and shared with the Aftenposten, their national newspaper, the case of a man who died from sepsis caused by a prostate biopsy. I told the story in Medium of how Roar Gulbrandsen, 68, a stonemason from Oslo underwent a routine transrectal biopsy and died a few days later from a brain clot.
His daughter, Agnes Gulbrandsen, 41, an Oslo hairdresser, was puzzled by the death and suspected that the transrectal biopsy was connected. Most of her father's doctors denied there was a link to the biopsy. But Johansen, who performed the biopsy, thought the transrectal procedure led to Gulbrandsen's death.
The daughter and the urologist started an unlikely campaign and brought Roar's case to the attention of the media.
The story outraged the Norwegian public, sparking a national review of antibiotic resistance and complication rates. Experts argued that unless urologists were performing a rectal swab test prior to biopsy, the transrectal route should be replaced by the transperineal route. Some urologists pushed back, but the adoption of transperineal procedures happened overnight, except in rural areas in the north.
Johansen dealt with transrectal biopsies as a public hazard. He was in the tradition of Ignaz Semmelweis, a Hungarian physician who discovered how to prevent deadly maternal infections in 1847 through hand washing and disinfecting instruments. Johansen, long-time chair of the infection committee of the European Association of Urology, brought the case to the EAU.
Urologists of conscience have started to campaign for the abandonment of the transrectal biopsy and a switch to transperineal biopsies.
Popert is one of the leaders of a group of top urologists from around the world who called for the transrectal biopsy to be abandoned and suggested a plan to phase it out by the end of 2022. They dubbed their campaign with a pun: TRexit.
What About Biopsies in the U.S.?
The word about this advance in biopsy technology is slowly getting out in the U.S. The AUA's 2017 guidelines recognize transperineal biopsies as a legitimate choice, but only mention a cumbersome older version done under general anesthesia in operating rooms, not the newer "free-hand" technique done under local anesthesia.
The AUA ought to follow the example of the EAU, which in January 2021, issued a position paper stating: "Available evidence highlights that it is time for the urological community to switch from a transrectal to a transperineal [prostate biopsy] approach despite any possible logistical challenges."
The AUA needs to update its guidelines and immediately start saving unsuspecting patients from severe complications and death. AUA will be debating the issue at its annual meeting in Las Vegas in September.
Active Surveillance Patients International, an advocacy group I co-founded is holding a roundtable on the issue at its meeting at noon ET on April 24. I'm a journalist, but these issues turned me into a bit of an activist.
Medicare, insurance companies, and U.S. policymakers need to get into the act to save money, and, more importantly, lives. Patient advocacy groups ought to lobby for change rather than just putting out a hand to raise research funding.
The bottom line is simple: Men should not die nor be disabled from sepsis caused by transrectal prostate biopsies. TRexit now.
Howard Wolinsky is a Chicago-based medical freelancer who has written this blog about his cancer journey for MedPage Today since 2016. He is the author of the just-released book, Contain and Eliminate: The American Medical Association's Conspiracy to Destroy Chiropractic.