Postoperative nonunion is not uncommon in the lower extremity, and significant morbidity can be associated
with nonunion of the foot and ankle after surgical reconstruction. For the purposes of the present study, we
retrospectively reviewed and compared a cohort of patients who had undergone elective foot and ankle
reconstruction to better assess the modifiable risk factors associated with postoperative nonunion. We hypothesized
that the presence of endocrine and metabolic abnormalities are often associated with nonunion
after foot and ankle surgical reconstruction. We formulated a matched case-control study that included 29
patients with nonunion and a control group of 29 patients with successful fusion to assess the prevalence of
certain modifiable risk factors known to have an association with nonunion after foot and ankle arthrodesis.
The modifiable risk factors assessed included body mass index, tobacco use, diabetes mellitus, vitamin D
abnormality, thyroid dysfunction, and parathyroid disease. A statistically significant (p < .05) difference was
found between the 2 groups for endocrine and metabolic disease diagnoses in the medical records of the 58
patients identified. Thus, 76% versus 26% (p < .05) of patients experienced nonunion in the endocrine disease
group versus the nonendocrine disease group, respectively. Patients with vitamin D deficiency or insufficiency
were 8.1 times more likely to experience nonunion (95% confidence interval 1.996 to 32.787). No statistically
significant differences were found between the groups in terms of age, sex, tobacco use, body mass index, or
procedure selection (p ¼ .56, p ¼ .43, p ¼ .81, p ¼ .28, and p ¼ 1.0, respectively). A greater prevalence of
endocrine abnormalities, in particular, vitamin D deficiency and insufficiency, was associated with nonunion
after elective foot and ankle reconstruction. Patients with such abnormalities appear to have a greater risk of
developing nonunion after arthrodesis procedures.
2017 by the American College of Foot and Ankle Surgeons. All rights reserved.
New ultrasound technique is first to image inside live cells
These are stem cells becoming fat cells. Using the ultrasound technique, we can start exploring why fat cells put on fat and whether we can make the cells ‘diet’. Credit: University of Nottingham
December 21, 2016
Source: University of NottinghamSummary:
Researchers have developed a breakthrough technique that uses sound rather than light to see inside live cells, with potential application in stem-cell transplants and cancer diagnosis.
Researchers at The University of Nottingham have developed a break-through technique that uses sound rather than light to see inside live cells, with potential application in stem-cell transplants and cancer diagnosis.
The new nanoscale ultrasound technique uses shorter-than-optical wavelengths of sound and could even rival the optical super-resolution techniques which won the 2014 Nobel Prize for Chemistry.
This new kind of sub-optical phonon (sound) imaging provides invaluable information about the structure, mechanical properties and behaviour of individual living cells at a scale not achieved before.
Researchers from the Optics and Photonics group in the Faculty of Engineering, University of Nottingham, are behind the discovery, which is published in the paper ‘High resolution 3D imaging of living cells with sub-optical wavelength phonons’ in the journal, Scientific Reports.
“People are most familiar with ultrasound as a way of looking inside the body — in the simplest terms we’ve engineered it to the point where it can look inside an individual cell. Nottingham is currently the only place in the world with this capability,” said Professor Matt Clark, who contributed to the study.
In conventional optical microscopy, which uses light (photons), the size of the smallest object you can see (or the resolution) is limited by the wavelength.
For biological specimens, the wavelength cannot go smaller than that of blue light because the energy carried on photons of light in the ultraviolet (and shorter wavelengths) is so high it can destroy the bonds that hold biological molecules together damaging the cells.
Optical super-resolution imaging also has distinct limitations in biological studies. This is because the fluorescent dyes it uses are often toxic and it requires huge amounts of light and time to observe and reconstruct an image which is damaging to cells.
Unlike light, sound does not have a high-energy payload. This has enabled the Nottingham researchers to use smaller wavelengths and see smaller things and get to higher resolutions without damaging the cell biology.
“A great thing is that, like ultrasound on the body, ultrasound in the cells causes no damage and requires no toxic chemicals to work. Because of this we can see inside cells that one day might be put back into the body, for instance as stem-cell transplants,” adds Professor Clark.
From prints to prison: Forensic podiatry and gait analysis gain ground
INCREASINGLY, lower extremity experts are being called on to assist with crime scene investigations by analyzing footprints, shoe prints, and the gait patterns of shadowy figures on security videos. For members of this fledgling field, as Sherlock Holmes famously said, the game is afoot.
By Shalmali Pal
The in-person diagnosis of lower limb conditions, or assessing foot and gait mechanics, is second nature to lower extremity practitioners. But what happens if the assessment required involves a foot that isn’t actually in the exam room—say, a shoe print embedded in the mud under a window, a footprint left in blood on a kitchen floor, or closed-circuit television (CCTV) footage of an otherwise unidentifiable person walking away?
What kind of deductions could be made about the absentee owners of those shoes or feet, the way they walk, and—importantly—their potential level of involvement in a crime? That’s when forensic podiatry and gait analysis enter the scene.
“Come, Watson, come!” he cried. “The game is afoot. Not a word! Into your clothes and come!” – Sherlock Holmes, The Adventure of the Abbey Grange
he now-deceased Norman H. Gunn, DPM, of Canada is credited with introducing the concept of forensic podiatry in the early 1970s; about two decades later, an introductory article on the subject appeared in the Journal of the American Podiatric Medical Association.1 The Bandon, OR-based American Society of Forensic Podiatry (ASFP) was established in 2003, and four years later, a forensic podiatry subcommittee was established by the Hollywood, FL-based International Association for Identification (IAI).
“The field of foot evidence is relatively new,” said John DiMaggio, DPM, ASFP, founder and president, and a retired podiatrist who has practiced in Arizona and Oregon. “Forensic podiatry can offer additional information when a case isn’t conclusive, based on anatomy, biomechanics, morphology, and pathology. We can offer more details about a person and his feet.”
ASFP currently has 25 practicing podiatrist members, along with 15 podiatry residents and 70 students, both in podiatry and in other disciplines (eg, anthropology, medical examiners), said DiMaggio, who is a coauthor of the second edition of Forensic Podiatry: Principles and Methods.2
LER spoke with DiMaggio and other experts in the field about what they do, how forensic podiatry and gait analysis work, and how lower extremity practitioners can become involved.
Figure 1. A comparison of a footprint with a shoeprint left at the scene of a crime. (Photo courtesy of John DiMaggio, DPM.)
Footprints and footwear
Although TV shows and mainstream media outlets tend to use the terms synonymously, there is an important distinction between footprints and shoe prints.
“If you are looking to match a suspect to a shoe print, the foot examiner is the main person to go to,” explained Michael Nirenberg, DPM, founder of Friendly Footcare in Crown Point, IN, ASFP vice president, and a contributing author to the Forensic Podiatry textbook. “If you are looking to match a suspect to a potential footprint, then the forensic podiatrist is the right person for that. You need a knowledge of the foot to make that comparison.”
Footwear examination has become more prevalent in crime scene investigation in the last two decades, and that expertise is typically limited to outsoles, DiMaggio agreed.
“When I hear the word ‘footprint,’ I think of the foot and not the shoe, and that’s where the podiatric expertise lies. As a forensic podiatrist, I can still examine the outsole, looking for heel wear or wear under the ball of the foot, but I can also examine the upper of a shoe and see where the wearer has a bunion deformity. Looking only at the shoe’s outsole would not reveal that kind of information.”
One case that was a win for forensic podiatry was the overturned conviction of Ray Krone, of Phoenix, AZ, for the 1991 murder of a woman named Kim Ancona in a local bar. His initial 1992 conviction was based primarily on expert testimony that his teeth matched bite marks on Ancona’s breast and throat.3
When that conviction was overturned by a state court in 1996 because of legal technicalities, Krone was retried and found guilty once again, based on the bite marks but no other physical evidence. While Krone was in prison (10 years overall, with two years on death row), his attorneys began reworking the case to prove his innocence. That’s when DiMaggio got involved.
A shoe print estimated as coming from a men’s size 10 to 10.5 sneaker was found at the crime scene, but this piece of evidence was not included in initial court cases. DiMaggio was called in by the defense attorneys to evaluate that shoe print and to make a cast of Krone’s foot. He submitted a report verifying that Krone’s shoe size was an 11 to 11.5 and that his foot could not have fit into the shoe that left the incriminating print.
The forensic podiatry evidence was part of the overall package, including new DNA evidence, that ultimately led to the conviction of the real killer and brought about Krone’s release in 2002.3
“Was the information about Krone’s foot the deciding factor that got his conviction overturned? I wouldn’t say that,” DiMaggio said. “I think the foot analysis that I performed added to the weight of evidence.”
A high-tech field?
While technologies such as 3D scanning have made inroads in the clinic, they haven’t quite caught on in forensic podiatry. That may be because the field is quite small and quite new, DiMaggio noted.
But technology is part of its founders’ vision. Nirenberg proposed the use of a fiber-optic arthroscopic camera for examining the inside of a shoe.
“The insides of shoes and boots often contain wear patterns and impressions,” Nirenberg wrote in the Journal of Forensic Identification in 2008.4 “These wear marks contribute to individuality and aid in linking a given shoe or boot to a specific person’s foot.”
Such wear marks may appear on the shoe’s insole or the upper, often in the form of an imprint left by the wearer’s foot. The inside of the footwear may also contain materials (eg, soil or blood) that could help place a suspect at a crime scene, Nirenberg explained.
Traditional examination of the inside of footwear involved using a small dental mirror or cutting the footwear open—what Nirenberg called a “shoe autopsy.” To examine the inner shoe with an arthroscopic camera, he advised starting at the posterior aspect and working forward to the toebox, noting “the arthroscope will allow the relationship between the foot’s impression on the insole and on the toebox to be clearly seen.”
Nirenberg told LER that arthroscopic examination also allows for preservation of the footwear, along with a record of the exam process.
“You can see a lot more detail with the fiber-optic camera,” he said. “You also can record the exam process in case the jury wants to see the inside of the shoe before it’s disassembled. The jury can see how you examined the inside of the shoe and any impressions of the foot.”
Figure 2. The FBI Bureau Reference Scale, developed by the agency’s footwear examiners, is considered the gold standard for determining size from an image. (Photo courtesy of John DiMaggio, DPM.)
Going by the gait
Gait analysis for forensic purposes is defined as “the analysis, comparison, and evaluation of human gait including the components and features of gait, to assist the process of identification or to answer any other legal question concerning gait,” according to Forensic Podiatry.2
“Gait analysis works with what we call ‘class characteristics.’ These are features that show consistency and compatibility, but are not unique,” explained Wesley Vernon, OBE, PhD, DPodM, coauthor of Forensic Podiatry and retired head of podiatry services at Sheffield Teaching Hospitals NHS Foundation Trust in England. “As such, gait analysis can be used with varying degrees of certainty to suggest how likely or unlikely it is that the unknown person captured on CCTV is the same [as a potential suspect].”
These class characteristics include elements with which all lower extremity practitioners are familiar—the gait cycle, including stance and swing phases; single- and double-support phases; and any deviations from a typical gait cycle because of functional anomalies and compensation from underlying pathologies.1
In 2007, Peter K. Larsen, PhD, a researcher in the section of forensic pathology, department of forensic medicine, at the University of Copenhangen in Denmark, and colleagues published a checklist for forensic gait analysis in the Journal of Electronic Imaging.5 Lower extremity areas of interest for forensic gait analysis are:
General: Long or short steps, stiff or relaxed, signs of pathology
Feet/ankle joint: Outward rotation, inversion/eversion, degree of “push-off” at toe-off Knee: Varus/valgus, knee flexion during stance
Hip/pelvis: Abduction/adduction, rotation, tilt
These elements are then paired with upper body assessments, such as positioning of the shoulder, neck, and head.
Larsen’s group applied this checklist to help solve a 2004 bank robbery in Noerager, Denmark. They analyzed CCTV footage of the perpetrator walking in and out of the bank and standing during the robbery. They started by evaluating the general characteristics of the person’s gait and then analyzing each of the joint rotations. They noted the person on the footage had a “stiff gait with ‘heavy’ feet; marked outward rotation in the foot and ankle joint; neutral varus/valgus knee; and very little pelvic rotation.”
Once a suspect was picked up by the police, the gait analysis of the perpetrator on the footage was deemed a positive match with another gait analysis of a suspect by Larsen’s group. The gait analysis was further bolstered by a posture analysis, leading Larsen’s group to conclude “the perpetrator and suspect might well be identical to each other, but we stressed that these methods did not constitute identification in terms of…DNA typing or fingerprinting.”
That is one of the crucial points to remember with forensic gait analysis: It’s a tool that can help increase the likelihood of pinpointing a suspect, but it cannot make a definitive identification or offer information beyond the limits of the lower extremities. For instance, when asked if gait analysis could be used to corroborate an eyewitness statement regarding a person seen fleeing a scene, potentially confirming or refuting that account, Vernon answered “yes,” but cautioned that the witness statement would have to include some description of the suspect’s gait.
“Forensic gait analysis utilizes our knowledge of gait and, as such, a forensic gait analyst would not report on height, weight, etc, with their opinions being restricted to areas that fall within their own particular expertise,” he wrote in an email.
Other researchers offered similar caveats. A 2016 paper in the Journal of Forensic Sciences noted that analysis of gait patterns from CCTV footage, paired with photogrammetry (the science of making measurements from photographs), were important but challenging forensic tools. By way of example, the authors tested the feasibility of 3D reconstructions for forensic gait analysis, and found considerable interobserver variability in data interpretation.6
Larsen’s group stressed that “in our work, we have both overt and covert recordings of the subject. There might be a potential problem in using overt recordings if the suspect consciously tries to modify the gait pattern during recording…at present, we do not find it possible to positively identify a perpetrator based on image analysis.”
Ultimately, forensic gait analysis data are only as good as the footage provided for that evaluation, the experts agreed. Larsen explained to LER in an email that the frequencies of oscillations during normal walking range up to 6 Hz, so the 12 Hz to 15 Hz frequency that modern CCTV units use should be more than sufficient to clearly capture even the quickest ambulator.
In a 2014 study in Science and Justice, Vernon and colleagues showed that CCTV frame rate, which can vary from 25 frames per second to one frame every four seconds, can affect the ability of even the most experienced practitioners to identify gait characteristics on that footage.
“Every effort should therefore be made to ensure that CCTV footage likely to be used in criminal proceedings is captured at as high a frame rate as possible,” they noted.7
Vernon acknowledged that new technologies, such as digital media, can be helpful for playing back an image at multiple speeds or looking at multiple images simultaneously on a single screen.
“Computer engineers are working on developing approaches that will do automatic gait analyses and comparisons, but these haven’t yet been developed to the point where they can be used in [forensic] practice,” he noted.
Data on what does and doesn’t work for forensic gait analysis can be used to inform where cameras are placed in public venues. Larsen’s group found most gait features can be examined using a frontal camera view and another in profile to record joint and segment angles in the sagittal plane. Some venues also have a camera positioned overhead to provide a transverse view of a perpetrator; this view can be helpful for assessing the degree of rotation of the feet and step length, but in general, is not as useful as the frontal view, Larsen said.
Vernon added that proper storage of high-resolution footage is always important to maintain the integrity of the evidence and support any related gait analysis.
Figure 3. A shoeprint compared with a cast of a foot, used to illustrate that a suspect’s foot was too big to fit into the specific shoes associated with a crime. (Photo courtesy of John DiMaggio, DPM.)
On solid footing?
Where does forensic podiatry fit into the overall landscape of usable or permissible evidence for solving a crime? Ruth Morgan, DPhil, director of the University College London Centre for Forensic Sciences, specializes in trace evidence dynamics, or “understanding the behavior of trace evidence in different contexts and within different environments over space and time,” and the interpretation of evidence.8
“Footprint and gait analysis are most aligned with other pattern-based forms of evidence [like blood pattern analysis, for example],” Morgan told LER by email. “Our trace evidence dynamics work looks at trace evidence [particulates such as soils, gunshot residue, and other traces such as trace DNA] and how it transfers, persists, and is preserved under different environmental conditions.”
For instance, Morgan’s group authored a recent study in Forensic Science International that evaluated the generation of footwear marks in blood.9 They reported that “footwear tread effects were also dependent on blood type, but the type of flooring did not affect the appearance of the mark.”
“The study first looked at whether there was a difference in replicating a case scenario in which a blood mark was purported to have been made by a shoe making contact with a blood drop on the floor,” she explained. “We tested human and animal blood, and the results were not consistent when the other variables remained the same. In comparison, if the same blood type was used, the type of flooring material did not appear to affect the blood pattern.”
As with all evidence, data gleaned from forensic podiatry and gait analysis needs to fit into the big picture, Morgan added.
“Our interpretation of evidence work looks at the whole forensic science process—from crime scene, to laboratory analysis, to the interpretation of that evidence and its presentation as intelligence [to investigators] or as evidence [in court],” she said.
Forensic podiatry has a connection with the US Supreme Court, thanks to the Daubert standard.10In his chapter in Forensic Podiatry,1 Nirenberg wrote that the highest court in the land “explained in Daubert that evidence is admissible under [Federal Rules of Evidence 702: Testimony by Expert Witnesses] if ‘it rests on a reliable foundation and is relevant.’”
In a 2014 case in Mt. Morris, WI, Robert Kasun was found murdered in a hotel room.11 Investigators arrested Travis L. Peterson, who was staying in the room next to Kasun’s, and he was charged with first-degree intentional homicide. At the crime scene, blood was found near the body, and chemical enhancement revealed a footprint. Nirenberg was asked for his expert opinion—could the bloody footprint have been made by Peterson?
Nirenberg’s forensic podiatry analysis and report showed commonality between Peterson’s foot and the footprint, including the shape of the toes. Nirenberg noted the bloody footprint exhibited a dark ridge on the second and third toes, which matched the morphology of Peterson’s actual foot. The pattern made the footprint unique to Peterson, according to Nirenberg.
The defense attorneys challenged the validity of the forensic podiatry findings, so a Daubert hearing was held to determine if the footprint analysis, and Nirenberg’s testimony, was admissible. The judge in the case green-lighted both, and Nirenberg testified at the Peterson trial. Peterson was found guilty and sentenced to life in prison.
“This was the first instance of forensic podiatry being the primary subject of a Daubert hearing,” Nirenberg wrote in a 2016 Journal of Forensic Sciences case report.12 “The hearing resulted in the court ordering this evidence admissible. The expert’s testimony contributed to the suspect’s conviction. It’s a win for forensic podiatry, because that Daubert hearing showed that the evidence met the Supreme Court standards. In that sense, it’s an important step for validating forensic podiatry as a subspecialty.”
The case also highlights the fact that lower extremity professionals with an interest in the field cannot rely solely on their medical expertise—a knowledge of crime scene investigation tech- niques, the criminal justice system, and the basics of forensic science are essential.
“Interpreting elements of the foot is not like DNA or a fingerprint in terms of how definitive it is,” DiMaggio noted. “It’s important that podiatrists understand how to interpret evidence within the context of the criminal justice system.”
To that end, the ASFP has plans to offer in-person seminars and webinars in the future.
“It’s important to have the forensics foundation, and understand how forensics do and don’t apply to issues of the foot that we as podiatrists are more accustomed to dealing with,” Nirenberg said.
In the meantime, podiatrists who would like to learn more can visit the resources library at ASFP, or consider courses given through the IAI, the American Academy of Forensic Sciences, or the American Board of Criminalistics. The New York College of Podiatric Medicine in New York City, Temple University School of Podiatric Medicine in Philadelphia, and Barry University School of Podiatric Medicine in Miami Shores, FL, also have set up forensic podiatry groups for their students.
“We have very good, dedicated DPM members,” DiMaggio noted. “It’s at the student level that we have to get people interested if we are going to grow this field.”
Shalmali Pal is a freelance writer based in Tucson, AZ.
A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’
After learning she had breast cancer, Raylene Hollrah of Hermann, Mo., had a double mastectomy. But then cancer struck again — caused by the implants used to rebuild her chest
WHITNEY CURTIS FOR THE NEW YORK TIMES
By DENISE GRADY
MAY 14, 2017
Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.
In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest.
“My whole world came crumbling down again,” said Ms. Hollrah, now 43, who owns an insurance agency in Hermann, Mo. “I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer. I thought, ‘I’m not going to see my kids grow up.’”
Her disease — breast implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer. If detected early, the lymphoma is often curable.
The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling. But the added warnings are deeply embedded in a dense list of complications, and no implants have been recalled. The F.D.A. advises women only “to follow their doctor’s recommended actions for monitoring their breast implants,” a spokeswoman said in an email this month.
Until recently, many doctors had never heard of the disease, and little was known about the women who suddenly received the shocking diagnosis of cancer brought on by implants.
An F.D.A. update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the F.D.A.’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease.
Women who have had the lymphoma say that the attention is long overdue, that too few women have been informed of the risk and that those with symptoms often face delays and mistakes in diagnosis, and difficulties in receiving proper care. Some have become severely ill.
Implants have become increasingly popular. From 2000 to 2016, the number of breast augmentations in the United States rose 37 percent, and reconstructions after mastectomy rose 39 percent. Annually, nearly 400,000 women in the United States get breast implants, about 300,000 for cosmetic enlargement and about 100,000 for reconstruction after cancer, according to the American Society of Plastic Surgeons. Allergan and Mentor are the major manufacturers. Worldwide, an estimated 1.4 million women got implants in 2015.
“I’d like to think that since then we’ve made progress on that,” Dr. Clemens said.
Late last year, an alliance of cancer centers, the National Comprehensive Cancer Network, issued treatment guidelines. Experts agree that the essential first step is to remove the implant and the entire capsule of scar tissue around it. Otherwise, the disease is likely to recur, and the prognosis to worsen.
Not all women have been able to get the recommended treatment. Kimra Rogers, 50, a nursing assistant in Caldwell, Idaho, learned last May that she had lymphoma, from textured implants she had for more than 10 years. But instead of removing the implants and capsules immediately, her doctor prescribed six rounds of chemotherapy and 25 rounds of radiation. A year later, she still has the implants.
“Unfortunately, my doctor didn’t know the first line of defense,” Ms. Rogers said.
She learned about the importance of having the implants removed only from other women in a Facebook group for those with the disease.
Her health insurer, Blue Cross Blue Shield of Montana, covered the chemotherapy and radiation but has refused to pay for removal of the implants, and told her that her appeal rights were “exhausted.” In a statement sent to The New York Times, a spokesman said, “Cosmetic breast implants are a contract exclusion, as are any services related to complications of the cosmetic breast implants, including implant removal and reconstruction.”
Physicians dispute that reasoning, saying the surgery is needed to treat cancer. Her lawyer, Graham Newman, from Columbia, S.C., said he was planning a lawsuit against the implant makers, and had about 20 other clients with breast-implant lymphoma from Australia, Canada, England and the United States.
Ms. Rogers has been unable to work for a year. If she has to pay to have the implants removed, it will mean taking out a $12,000 loan.
“But it’s worth my life,” she said.
Insurers generally cover implants after a mastectomy, but not for cosmetic enlargement, which costs $7,500 or more. Repeat operations for complications are also common, and usually cost more than the original surgery.
Diagnosis and Treatment
Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants.
Dr. Mark W. Clemens II is a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston. TAMIR KALIFA FOR THE NEW YORK TIMES
Most implants in the United States are smooth. But for some, including those with teardrop shapes that would look odd if they rotated, texturing is preferable, because tissue can grow into the rough surface and help anchor the implant.
Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy.
What’s inside the implant — silicone or saline — seems to make no difference: Case numbers have been similar for the two types. The reason for the implants — cosmetic breast enlargement or reconstruction after a mastectomy — makes no difference, either.
Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit.
To make a diagnosis, doctors drain fluid from the breast and test it for a substance called CD30, which indicates lymphoma.
The disease is usually treatable and not often fatal. Removing the implant and the entire capsule of scar tissue around it often eliminates the lymphoma. But if the cancer has spread, women need chemotherapy and sometimes radiation.
“In the cases where we have seen bad outcomes, it was usually because they were not treated or there was a major delay in treatment, on the level of years,” Dr. Clemens said. Doctors at MD Anderson have treated 38 cases and have a laboratory dedicated to studying the disease.
About 85 percent of cases can be cured with surgery alone, he said. But he added that in the past, before doctors understood how well surgery worked, many women were given chemotherapy that they probably did not need.
Case reports on the F.D.A. website vary from sketchy to somewhat detailed and rarely include long-term follow-up. Some describe initial diagnoses that were apparently mistaken, including infection and other types of cancer. In some cases, symptoms lasted or recurred for years before the right diagnosis was made.
What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted.
“It could also just be the immune system response to some component of the texturing,” Dr. Clemens said. The rough surface may be irritating or abrasive. Allergan implants seem to be associated with more cases than other types, possibly because they are more deeply textured and have more surface area for bacteria to stick to, he said. Allergan uses a “lost-salt” method that involves rolling an implant in salt to create texture and then washing the salt away. Other makers use a sponge to imprint texturing onto the implant surface.
Allergan is studying bacterial biofilms, and immune and inflammatory responses to breast implants, a spokesman said in an email. He said the company took the disease seriously and was working with professional societies to distribute educational materials about it.
Another possible cause is that some women have a genetic trait that somehow, in the presence of implants, predisposes them to lymphoma. Dr. Clemens said researchers were genetically sequencing 50 patients to look for mutations that might contribute to the disease.
Dr. Clemens was a paid consultant for Allergan from 2013 to 2015, but not for breast implants, and no longer consults for any company, he said.
A spokeswoman for Mentor said the company was monitoring reports about the lymphoma, and stood behind the safety of its implants.
‘You Have Cancer Again’
Ms. Hollrah had implants inserted in 2008 and felt fine for five years. Then in 2013, in a matter of days, her right breast tripled in size, filling painfully with fluid.
Her plastic surgeon removed the implant and replaced it. He had just read about the lymphoma, so to be on the safe side, he ordered CD30 testing. The results were positive.
“It’s a moment I’ll never forget,” Ms. Hollrah said. “He said, ‘You have cancer again, but it’s not breast cancer.’”
On her doctor’s recommendation, she saw Dr. Clemens, who removed the implants and surrounding tissue. Chemotherapy and radiation were planned but turned out to be unneeded, because tests found no spread of the cancer. She remains well, but returns to MD Anderson once a year for scans.
“I will be monitored for the rest of my life,” she said.
She started a nonprofit, Just Call Me Ray, to help educate women about implants, and she participates in the Facebook group for women who have had the implant-related cancer.
Other women have needed more extreme treatment. Terri McGregor, 52, from North Bay, Ontario, had implant surgery in 2009. Six years later, after a routine mammogram with normal results, she felt lumps in her breast. Thinking the mammogram had ruptured her implants, her doctor removed and replaced them.
Because the tissue around the implants looked abnormal, he had it tested for CD30.
Ms. McGregor was stunned to learn she had the implant-associated lymphoma.
“I had no symptoms,” she said.
The new implants had to be removed. Further tests led to another shock: The cancer was advanced. Ms. McGregor felt ashamed, because she had gotten the implants simply to improve her appearance.
“I brought this on myself. I brought this on my family,” she said. “I really needed to work through that shame and guilt.”
Two chemotherapy regimens failed. In March 2016, she was given three to six months to live. She sold her paving business but tried to keep the prognosis from her sons, who were 20 and 23.
There was one more option: a drug called brentuximab vedotin.
“I had four rounds,” Ms. McGregor said. “The tumor on my chest literally disappeared.”
Doctors then gave her high-dose chemotherapy, a transplant of her own stem cells and, in December, 15 radiation treatments.
The aggressive treatment has taken its toll. She used to shovel asphalt and hoist 50-pound bags of cement.
“Now I struggle to carry my laundry basket upstairs,” she said.
She hopes the treatment has cured her.
Like Ms. Hollrah, she participates in the Facebook group, and thinks women need more information.
“Our motive is informed consent,” she said. “We are a bunch of very unorganized women doing that because they have a passion for it, and how do you process your injustice feelings but to try to make change?”
Stacey Boone, 51, of Bradenton, Fla., also needed a stem-cell transplant, for lymphoma that had invaded her liver by the time it was diagnosed. The disease is in remission.
“It’s been a long road,” she said.
Kim Crespo, 49, from Palm Beach, Fla., said she had consulted several plastic surgeons in Florida who even in 2016 had never heard of lymphoma associated with breast implants. Nor had her gynecologist. She was treated for the disease at MD Anderson.
Vikki Radow, 46, of Los Angeles, said that when she had heard the F.D.A. reported nine deaths from implant-associated lymphoma, “I said, ‘Oh, my God, my mother was one of those nine.’”
Ms. Radow’s mother, Bettye C. Yaller, first received an implant about 30 years ago after a mastectomy for breast cancer. She had the implant removed and replaced a few times, and began to have swelling and pain in 2009 or 2010, Ms. Radow said.
Doctors diagnosed an infection, removed the implant and replaced it. In 2012, at 76, her mother became short of breath and had pain and swelling in her breast, a lump in her chest, and swollen lymph nodes in her chest and neck.
“It started the most wild goose chase I’ve ever been on,” Ms. Radow said.
Her mother was hospitalized for two months, worsening steadily, as doctors struggled to determine what was wrong. In desperation, Ms. Radow’s husband consulted a physician friend, who suggested testing for lymphoma — and the diagnosis was finally made. By then, Ms. Yaller was critically ill, on a ventilator.
She improved with chemotherapy and came home from the hospital.
When she was considered strong enough for surgery, she went back to the hospital to have the implant removed. Her heart stopped on the operating table. She was resuscitated but died two weeks later.
Ms. Radow described her mother as a vibrant, lively woman who line danced, took water aerobics classes, traveled, belonged to a book group and reveled in the company of her children, grandchildren and great-grandchildren.
Her mother had no idea that there was any cancer risk from implants, and told doctors that if she had known, she never would have wanted one, Ms. Radow said, adding, “My mother was robbed of the rest of her life.”
Correction: May 14, 2017
An earlier version of this article gave an incorrect middle initial for a woman who died after contracting cancer from a breast implant. She was Bettye C. Yaller, not Bettye K. The error was repeated in an earlier version of a picture caption.
Smart contact lenses that make diabetes management easier for patients have been recently developed by Korean researchers. Small sensors are attached to the lenses to take blood sugar measurements and deliver diabetes medication accordingly. Moreover, they can be used in the treatment of a wide range of eye conditions such as retina diseases and glaucoma. Let’s learn about the new smart lenses and their applications in connection with ICT.
3 High School Teens Invent Straw That Could Detect Common Date Rape Drugs
Published on May 23, 2017
Three high school students are breaking ground on a product to detect date rape drugs. Victoria Roca, Susana Cappello, and Carolina Biagorri say they came up with the idea after seeing what a problem rape is in society. The straw prototype they designed can detect the most common date rape drugs. The girls hope to market the straws to college students and supply them at bars, clubs, and restaurants. InsideEdition.com’s Keleigh Nealon (https://twitter.com/KeleighNealon) has more.
New technique prevents strokes by reversing blood flow through brain
Oxygen-rich blood generally flows from the heart to the brain, but a new technology aimed at preventing strokes temporarily reverses that path.
Surgeons at Sharp Grossmont Hospital in La Mesa are the first in this region, and among a growing number nationwide, to use the system to channel blood from the brain through a special external filter and then injecting it back into the body via a vein in the leg.
The point of this unusual rerouting is to keep bits of plaque in a clogged carotid artery — plaque can be knocked loose during insertion of a stent — from traveling to the brain, where they can cause strokes.
“While the flow is reversed, any plaque that tries to break loose gets filtered out,” said Dr. Scott Musicant, a vascular surgeon at Sharp Grossmont.
Made by Silk Road Medical in Sunnyvale, the system is a new take on the well-established idea of using stents to open narrowed carotid arteries. Studies of this technology, which has been approved by the U.S. Food and Drug Administration and is covered by Medicare, found that only 1.4 percent of patients suffered strokes when undergoing the blood-flow-reversal technique. In comparison, strokes occurred in about 4 percent of patients who underwent regular stenting procedures.
The lower stroke rate is roughly equivalent to what’s seen with using surgery to remove plaque. But stenting is widely favored over surgery because it’s less invasive to the patient and doesn’t require general anesthesia.
Dr. Brajesh Lal, a University of Maryland vascular surgeon and co-investigator of a nationwide clinical trial that compares different methods of relieving severe plaque buildup in carotid arteries, said it will take a randomly-assigned clinical trial, which he hopes to perform, to fully prove that new techniques truly outperform those that have been in use for decades.
But, at present, flow reversal looks very promising.
“I’m actually quite enthusiastic about the future of this particular procedure,” Lal said.
Still, the idea of making blood flow backward in one of the main arteries that supplies the brain seems like it should cause some sort of damage to person’s gray matter.
Cue the jokes about backward thinking.
But flow reversal capitalizes on the amazing redundancy of the brain’s blood supply. Four arteries travel from the heart through the neck and to the brain, two on the left and two on the right.
The flow-reversal system requires the surgeon to clamp the carotid artery between the heart and the narrow spot where the stent is to be installed. This means blood flow from the heart to the brain stops until the clamp is released.
But, with its main path blocked, blood automatically starts squirting out of the artery from the brain toward the heart. The flow of blood automatically reverses itself.
This is because there are several interconnecting arteries among the four main arteries at the base of the brain, Musicant explained. These paths allow oxygen-rich blood in one path to dynamically shunt over to the clamped artery, filling it from the top rather than the bottom.
“It’s amazing how the brain can compensate … when you’re reversing blood out, the patient’s brain is still getting plenty of blood flow,” Musicant said.
The majority of carotid artery narrowing is still done through surgery due to higher stroke rates for stenting procedures. However, for several years surgeons have been placing stents by puncturing the carotid artery in patients’ necks, rather than going in through the groin. It’s a much shorter trip, and does not require threading the long, thin catheter wire through a structure called the aortic arch, which can also dislodge plaque and cause a stroke.
Other companies already market special filters for carotid arteries that can protect the brain by being pushed past the spot where plaque builds up, providing a way of catching the waxy gunk before it reaches the brain.
While the filters are much, much better than nothing, they still allow some smaller pieces of plaque through, potentially causing possible cognitive impairment even if they don’t trigger a stroke.
And, Lal added, the mere act of pushing a filter through a plaque-narrowed stretch of carotid artery can dislodge plaque.
“When you’re using flow reversal, you don’t have to cross the lesion,” Lal said.
At present, the flow reversal system is approved only for patients who are at a high risk of complications for undergoing a normal surgical procedure. The system can be used on patients who are experiencing neurological symptoms and have at least a 50 percent blockage of their carotid artery as verified by an ultrasound or angiogram test. Those with no neurological symptoms must have a blockage greater than 80 percent.
Have you foolishly decided NOT to participate in MIPS? I am always surprised when I speak to physicians who declare they do not want to participate in the CMS Quality Payment Program. They insist they are not going to let government tell them how to practice. I ask those of you with that mindset to please…think again. Physicians today should absolutely take part in MIPS, not only for monetary reasons but also because your Performance Score will be made public on the Physicians Compare website for all to see. This will be what is equivalent to being a physician’s Report Card.
MIPS is the Merit-based Incentive Payment System, where you earn a performance-based payment adjustment to your Medicare payment starting in 2019, determined by what data you report in 2017. If you do not participate, you will be voluntarily giving up 4% of your hard-earned money in 2017 that can escalate to 9% by 2022.
All you need to do is only ONE THING in 2017. That’s right, you only need to report on one Quality Measure or attest to participating in an Improvement Activity and you will earn enough MIPS points to avoid a penalty. Report on one measure, for one patient, for one visit. That’s it!
Please note this track is for claims reporting only. For registry, you need to report for 90 days. You do have a choice of how you want to report, but then you have different options and requirements. I would suggest discussing this with a consultant who is well versed on the subject of MIPS such as the team at Vital Profits.
Medicare will be pooling the monies from physicians who do not participate in MIPS, and will be using that money to fund the upward adjustments for physicians who submit their data. The amounts of upward adjustments may vary depending on the amount of money they have. Additionally, Medicare has a budget of $500 million allocated from 2019-2024 to reward physicians with outstanding performance scores! Let us at Vital Profits help you get started receiving the best reimbursement possible.
Below is a chart that shows the payment adjustments including possible bonus amounts for MIPS:
If you choose not to submit any data in 2017, then you receive a negative 4% payment adjustment from Medicare in 2019. As I mentioned earlier, if you submit just one measure by claims reporting, you receive a neutral payment adjustment. If you submit a minimum of 90 days of 2017 data to Medicare you will earn a neutral to positive payment adjustment, and if you submit up to a full year of data you will earn a positive payment adjustment.
Below is a table showing what you can expect according to how much you report.
I have added a table below, to help open your eyes, if you still don’t want to accept that the scale of these penalties can be substantial. This is an actual example of a physician’s Medicare payment adjustment for a level 3 office visit for 2017 reflecting none participation in 2015. The total negative adjustment is 6% for this office visit equaling $5.56, not counting the 2% government sequestration. Multiply that by how many office visits you do a day, a week and then a year. And that is just for an office visit.
Penalties in 2017 Incentive Program
OV Allowed amount
EHR, PQRS and VBM adjustment
2 % sequestration
Total negative program adjustment
15 ov a day @$5.56 penalty
2017 Penalty-Money lost
* each office visit has pay according to location
Participate in MIPS and do not miss out on this opportunity to keep your money and possibly receive a bonus! Don’t leave money on the table.
MIPS can be nearly painlessly accomplished. I can assume, if you are using an EHR right now, you have already met the requirements for 2017 and may not realize it. Please contact Vital Profits to find out where you stand right now and if you can avoid the penalty in 2019. Let us help you be successful with MIPS while you concentrate on helping your patients. You can achieve the maximum bonus available by getting the most points and attaining high performance status with our assistance.
It’s time to take charge of your MIPS score and be proactive about it. Vital Profits is available to help with your concerns and with decisions on what EHR may be best for your practice. Call us! We are here to help you. 855-848-2511