Friday, July 29, 2011

New medical FICO score sparks controversy, questions

Jeremy M. Simon, On Thursday July 28, 2011, 8:00 am EDT

Within the next 12 months, whether you like it or not, about 10 million Americans are expected to be scored -- much like a credit score -- on how likely they are to fill a prescription and take all the pills the doctor ordered, on schedule.

FICO , creator of the widely used credit score that predicts whether you'll borrow responsibly, is now rolling out its new Medication Adherence Score.

FICO based its score on a formula that predicts whether you will take your prescription drugs. FICO says that since correct use of medication is important for patients, medical providers, insurers and pharmaceutical companies, the Medication Adherence Score will help achieve that goal. They predict it will improve therapy effectiveness and reduce health care costs.

The company says those who score low can be targeted for extra reminders and educational efforts, with the goal of making patients more likely to complete their prescribed regimens.

"It's very important to identify those people who may need that additional education and that additional help," says Dave Shellenberger, senior principal consultant in FICO's health care division.

Critics aren't so sure. Since the score uses information on patients' employment, homeownership and living situations, they say that in the current economic environment, the Medication Adherence Score may unfairly target people who have found themselves in challenging financial situations. It could also, they say, open the door for a new way for insurance companies to charge different prices for different scores. This happened in recent years to consumers buying auto insurance: The cost of those policies are now likely based on an auto insurance credit score .

What's in the score?
FICO launched the Medication Adherence Score on June 23, 2011. To create the scoring algorithm, FICO looked at data from a random sample of several million anonymous patients provided by a large pharmacy benefits manager. FICO observed patients who filled (or refilled) their prescriptions and patients who failed to, with the company then identifying those variables that best predicted medication adherence. For the Medication Adherence Score, those variables include age, gender, family size and asset information -- such as the likelihood of car ownership -- data also used by direct marketing companies. FICO says that with only a patient's name and address, it can pull the remainder of the necessary information from publicly available sources.

The scores range from 1 to 500. "The higher the score, the higher the likelihood a patient will be adherent to a drug regimen," FICO's Shellenberger says. FICO says patients who score 400 or higher are likely to take medication as prescribed, while those who score below 200 are at high risk of not taking medication. According to FICO, patients who earn a low score may receive a medication reminder in the form of an email, letter or phone call from their doctor -- tactics that would be too costly to apply across the board.

FICO says those who wouldn't want to receive notices should contact their health care providers and ask about their opt-out policies. High scorers who appear likely to take all their meds probably won't be contacted.

Click here to read the rest!

Thursday, July 28, 2011

Robotic surgery gains popularity

Patients appreciate faster recovery; surgeons report ability to see better
By Rhiannon Meyers
Corpus Christi Caller Times

Posted July 23, 2011 CORPUS CHRISTI — As the patient lay motionless on the table, her belly exposed and marked for a hysterectomy, Dr. Laura Shelton prepped for surgery.Shelton removed her plastic face shield and pulled off her sanitized surgeon's gown. She sank into a rolling chair, pushed up her long sleeves to the elbows and kicked off her tennis shoes.

For the next hour, Shelton performed the hysterectomy in a pair of pink and gray ankle socks sitting at a console 6 feetfrom the patient.

A live video feed from within the woman's abdomen illuminated Shelton's pale blue eyes as she worked a set of joysticks guiding robotic arms that cut, cauterized and sutured.

This, Shelton said, is the future of surgery.

The growing popularity of this pricey equipment — which can cost more than $2 million, according to some estimates — has sparked a debate on the merits and risks of robotic surgery.

Both local hospital systems now have surgical robots in an effort, hospital officials say, to provide minimally invasive surgery that shortens patients' hospital stays. Christus Spohn Health System bought one last year and Corpus Christi Medical Center added one in January.

Surgeons who use the robots say the technology allows patients to recover quicker because they lose less blood — less than a tablespoon, in some cases — and the incisions are smaller, sometimes less than half an inch.

"We can have them back on their feet in a week instead of six weeks," said Dr. Stan Shoemaker, an obstetrician/gynecologist who operates at Corpus Christi Medical Center. "It's a much more attractive alternative."

Advocates also say robotic surgery causes less physical strain on the surgeon and could lengthen a doctor's career in the operating room. Shoemaker said the robot also allows him to perform more challenging surgeries in a minimally invasive way.

"I'm not nearly as frightened about a tough case," Shoemaker said.

But others argue that the benefits are overstated and driven by marketing, at times by the robot's manufacturer, Intuitive Surgical Inc., which earned $1.4 billion in its last fiscal year.

One recent study suggested there was no solid scientific evidence to back claims that robotic surgery is more precise and results in less pain. The study, released in May by Johns Hopkins University School of Medicine researchers, also argued that hospitals often use Intuitive Surgical's promotional materials and fail to talk about robotic surgery risks, including claims that such surgeries can take more time, causing patients to remain under anesthesia longer, and that they are more costly.

There remains a healthy debate about the merits of traditional surgery versus the robotic procedure, said Dr. Benjamin Lowentritt, a urologist in Baltimore who solely offers robotic surgery.

"I don't think it does anyone any good to declare it as a cure-all and the perfect treatment," he said. "I would not advocate (open surgery) in my practice, but at the same time, I don't fault anyone for making that choice."

Still, Lowentritt said, it's difficult for any hospital to opt against offering robotic surgery because of the strong patient demand.

"I wouldn't want to go to a hospital that didn't have it for my prostate care," he said. "To be a center that provides the full complement of care to your patients, I think it is something that you should have."

Plus, he said, robotic surgery acts as a good recruiting tool for new surgeons.

"As time goes on, hospitals and communities that don't have them will more and more have difficulty attracting newer and recently trained physicians," he said.n n nFor the past 1½ years, Debra Cantu, 34, struggled with near-constant pelvic pain and an overactive bladder. She popped pain relievers at least three times a week and ran to the bathroom once an hour. She woke frequently at night to use the restroom.

Shelton diagnosed her with uterine fibroids, which are noncancerous tumors, and possibly endometriosis, a painful condition where tissue typically lining the uterus grows outside the uterus, becomes inflamed and eventually develops scar tissue and adhesions, which bind organs together and causes pelvic pain, according to the Mayo Clinic.

Shelton recommended giving Cantu a partial hysterectomy using Christus Spohn Health System's da Vinci robot.

The robots are controlled solely by the surgeon, who sits at a nearby console and views the surgery through a viewfinder, where the images are magnified 10 times and appear in 3D.

Robotic instruments, which look like miniature forceps, are inserted through tubes in the patient's body. The surgeon uses joysticks to direct them to pinch, cut and sew.

Using a pedal that looks like a car accelerator, the surgeon can move around a small, lighted camera, usually inserted through a tube in the patient's belly button, to peek around organs and zoom in on blood vessels. The surgeon uses another pedal to deliver bursts of electricity that cauterize, or burn, tissue and blood vessels to seal them and stop the bleeding.

As Shelton worked at the console Wednesday – shoeless, she said, so she could better feel the pedals – she navigated the instruments past organs and blood vessels that filled the flat-screen televisions on each side of the operating room.

Shelton pointed to scar tissue and adhesions that marred the inside of Cantu's pelvis and decided she had to do a complete hysterectomy. It was the only option, she said, that could relieve Cantu of her pain, even though it would force the mother of two into early menopause.

It was an option they had discussed in a pre-operative appointment, but once Shelton saw in excruciating detail the extent of the scarring from Cantu's endometriosis, she said she realized the problem was worse than expected. Cantu's ovaries had adhered to her abdominal wall and scar tissue was tucked underneath her uterus, a typically hard-to-reach area for a surgeon.

Shelton said she wouldn't have been able to see such detail with traditional surgery, which likely would have been more challenging.

"The visualization is key," she said. "I could see exactly where the adhesions were, exactly where to cut."

Lowentritt, who said he was skeptical at first of what he thought would be a gimmicky new technology, said the visualization provided by robotic surgery changed his mind.

"I feel like it has made me a much better surgeon because I could see for the first time in ways I couldn't with open surgery," he said.n n nWhile hospitals nationwide offer robotic surgery for a variety of procedures, from heart surgery to gastric bypass, the local hospitals so far only offer it for gynecological and urologic surgeries, such as hysterectomies and prostate removals.

All surgeons working with the robot must be trained.

Christus Spohn Health System bought its robot for urologists at Spohn Hospital Shoreline, but officials moved the robot in March to Spohn Hospital South so it could get more use, spokeswoman Katy Kiser said.

The hospital system has used it 115 times, and five gynecologist surgeons now operate on it, da Vinci representative Michael Isaac said. Kiser said the hospital system has plans to train more surgeons on the robot and expand its surgical offerings, but no plans to buy additional robots.

Corpus Christi Medical Center bought a newer version of the robot in January and surgeons there since have performed 150 gynecologic and urologic procedures, hospital spokeswoman Lisa Robertson said. Twelve hospital system surgeons are trained on the robot, she said.

Dr. Joseph Wagner, director of robotic surgery at Hartford Hospital in Connecticut, said he considers a robot thoroughly used at 500 cases a year.

He suggests hospitals consider expansion if their robots hit 350 to 400 annual operations, well above the usage level at Corpus Christi hospitals.

Kris Muller, spokeswoman for Corpus Christi Medical Center's parent company HCA, said robotic surgery does not cost patients more than traditional surgery. Some insurance policies cover the full cost, others do not, Shelton said.

n n n

While the debate continues about the cost of the technology and long-term benefits for patients, there seems to be little argument that robotic surgery is better for the surgeon.

Surgeons say robotic surgery leaves them less fatigued, allows them to see better within the body and gives them the ability more easily to suture, or sew tissue, than they could with traditional laparoscopic surgery, a type of minimally invasive surgery in which surgeons work at the bedside using long, slender, chopstick-like instruments inserted through small incisions in a patient's body.

Dr. Alan Nesbit, a urologist who operates at Corpus Christi Medical Center, said the robot is easier on his body than traditional laparoscopic procedures, which left him exhausted.

His knees, hips and back ached after standing for five or six hours at a patient's bedside, his arms positioned in an awkward manner over the patient's body.

"No matter how strong you are, it's a very physical surgery," he said.

Shoemaker said, without the robot, his persistent back pain and arthritis likely would have forced him to take a break from surgery. Robotic surgery allows him to rest his back by sitting in a cushy chair at a console, instead of standing for hours at a patient's bedside.

"It's extended my surgical career by 10 years," he said.

At Cantu's hysterectomy on Wednesday, Shelton chatted easily while she performed complicated maneuvers within Cantu's pelvis. As she flicked her wrists at the joysticks, the robotic instruments pushed a tiny, thin needle with barbed-wire-like thread in and out of the tissue. Shelton said she was operating within a space the size of a pingpong ball.

This is the kind of technique that, if done in a traditional laparoscopic way, would have been more difficult and physically draining, Shelton said.

"I feel like I'm going to go exercise now and I wouldn't have wanted to go exercise had I done it laparoscopically," she said after the surgery. "I would've been too sore. I would've said, 'I've done my exercise for the day.'"

n n n

Experts say robotic surgery is likely to expand in coming years, particularly as the technology improves. Surgeons say they expect the devices will get smaller and eventually provide tactile feedback, giving surgeons back the sense of feel that they traded for the magnified, high-definition vision that came with robotic surgery.

Thursday, July 14, 2011

FDA warns mesh used in surgery poses risk

Problems seen in vaginal procedure
By Deborah Kotz and Robert Weisman
Globe Staff / July 14, 2011
Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the Food and Drug Administration.

The agency warned patients and surgeons to consider other options.

The FDA said it plans to convene an advisory committee of experts in the fall to determine whether to ban the mesh - manufactured by Natick-based Boston Scientific Corp., Covidien PLC of Mansfield, and several other companies - for this procedure.

About 100,000 women with pelvic organ prolapse are treated with plastic mesh each year, but in most cases, the agency said, the condition can be treated successfully without mesh.

Mesh-related problems reported to the FDA include pain ful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

Click here to read the rest
http://www.boston.com/lifestyle/health/articles/2011/07/14/fda_warns_mesh_used_in_vaginal_surgery_can_pose_risk

Friday, July 01, 2011

Mesh-related infections after hernia repair surgery

Mesh-related infections after hernia repair surgery
M. E. Falagas1,2, S. K. Kasiakou1Article first published online: 29 NOV 2004

DOI: 10.1111/j.1469-0691.2004.01014.x
Keywords:Hernia repair;infectious complications;mesh-related infection;Staphylococcus aureus;Staphylococcus spp
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Abstract
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
Clinicians have been challenged in the past few years by an increasing variety of novel non-infectious and infectious complications following the widespread use of meshes after open or laparoscopic repair of hernias. The possibility of a mesh-related infection occurring weeks or even years after hernia repair, should be considered in any patient with fever of unknown origin, or symptoms and/or signs of inflammation of the abdominal wall following hernia repair. The reported incidence of mesh-related infection following hernia repair has been 1%–8% in different series, and this incidence is influenced by underlying co-morbidities, the type of mesh, the surgical technique and the strategy used to prevent infections. An approach that combines medical and surgical management is necessary for cases of mesh infection. The antimicrobial treatment regimen chosen initially should include coverage of Staphylococcus spp. and, particularly, Staphylococcus aureus.

Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Introduction
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
Within the last few years, the use of meshes has become standard procedure in hernia repair surgery throughout the world. Implantation of a mesh during the surgical management of this common problem has been found to reduce the rate of recurrence of a hernia. For example, use of a mesh for the repair of incisional hernias has been found in different studies to decrease the recurrence rates by an average of 30%[1–3], while in a randomised clinical trial involving 289 patients in which non-mesh vs. mesh repair of primary inguinal hernia was compared, it was found that recurrence rates were 7% for the non-mesh technique vs. 1% for mesh repair [4]. However, mesh-related complications have become increasingly important. Such complications include seromas, adhesions, chronic severe pain, migration and rejection of the mesh, and mesh-related infections.

The present review focuses on mesh-related infections. Data for the review were obtained from searches of Medline, Current Contents and references from relevant articles. In addition, several articles were identified through searches of the extensive files of the authors. The search terms were ‘mesh’, ‘infection’, ‘open hernia surgery’, ‘laparoscopic hernia repair’, ‘inguinal hernia repair’, ‘infectious complications’, ‘biomaterials’, ‘antibiotic prophylaxis’ and ‘prevention’. All English language papers were carefully reviewed.
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Mesh-related non-infectious complications
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
Important advances in research and development by the biomedical materials industry have led to the production of relatively inert and biocompatible surgical meshes. However, it has been noted in clinical practice that surgical meshes can trigger various responses when implanted in the human body, including inflammation (known as foreign body reaction), fibrosis, calcification, thrombosis and infection.

Foreign body reaction refers to a process in which proteins such as albumin and fibrinogen are absorbed initially by the surface of the polymer. Subsequently, the physiochemical properties of each polymer result in the degradation of the absorbed proteins. This process results in the attraction and stimulation of macrophages, which respond by releasing inflammatory substances and growth factors. Other inflammatory cells (T-lymphocytes, polymorphonuclear cells, eosinophils, plasma cells and fibroblasts) are then attracted to the surface of the polymer, leading to the formation of a granuloma. Such granulomas are characterised by locally increased cell turnover, which may continue for periods of several years after the implantation of the mesh. Foreign body reaction also depends on the surface area of the mesh that is in contact with the host tissue [5]. Clinical manifestations of foreign body reaction are seroma, rejection, migration of mesh, adhesions and pain.

Meshes made of non-absorbable polymers have been used most frequently in clinical practice. The main non-absorbable polymers are polyester, polypropylene and expanded polytetrafluoroethylene. However, given the fact that absorbable polymers are associated less frequently with foreign body reactions and adhesion, newer meshes are made of a combination of absorbable and non-absorbable polymers [6,7]. The mechanical and biological properties of meshes are associated with the type of tissue structure (woven or knitted) and the type of fibre used (mono- or multifilament) [8]. The pore size of the mesh also plays a role in the safety and tolerability of surgical meshes [9].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Mesh-related infectious complications
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Incidence
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
Mesh-related infections following surgery occur relatively infrequently compared with other device-related infections. However, they are of considerable clinical importance, not only for the patients and surgeons, but also for other medical specialists. The question of whether the incidence of infectious complications is higher after hernia repair involving the use of a mesh, in comparison with older techniques not involving use of a mesh, remains controversial. The results of a recent trial in which a comparison was made between umbilical hernia repair with or without a mesh in 200 adults showed that the rate of post-operative complications, including infection, was similar following both procedures [10]. A similar result was obtained in a meta-analysis of 20 trials (5016 participants) of open mesh vs. non-mesh repair of groin hernias [11]. In contrast, the results of a randomised trial of 160 patients with simple or complex hernias who underwent suture repair, skin graft or mesh repair showed that the rate of infectious complications was lower following suture repair than following the other two techniques. In addition, mesh implantation led to an increased rate of infections following repair of both simple and complex hernias [12]. A further study showed that the use of mesh during the repair of a ventral hernia or a hernia defect > 10 cm in size was associated significantly with an increased number of wound complications [13].

Incidences of mesh-related infection after hernia repair of up to 8% have been reported (Table 1) [14–18]. The rate of infection is influenced considerably by underlying co-morbidity, and seems to be increased in patients with diabetes, immunosuppression or obesity. Of great interest is whether the type of prosthetic material or the precise technique used for hernia repair can influence the incidence of mesh infection. In most recent published trials, the differences in complication rates following different surgical approaches and the use of different meshes have been compared. However, none of these studies focused specifically on the mesh-related infection rates. Leber et al.[19] conducted a retrospective cohort analysis of 200 patients who underwent open repair of abdominal incisional hernias with prosthetic material, with the aim of determining whether the incidence of long-term complications was influenced by the surgical technique. The authors concluded that the precise surgical approach did not influence the incidence of long-term complications significantly, including mesh infection. Although several authors have suggested that the laparoscopic approach to hernia repair has fewer post-operative complications compared to open repair, there are no clear, specific data regarding mesh-related infection rates [20–22].

Table 1. Incidence of mesh infection after laparoscopic or open hernia repair surgery Reference Study population (n) Technique of hernia repair Incidence of mesh infection
Heniford et al.[14] 407 Laparoscopic ventral and incisional hernia repair 0.98%
Heniford et al.[15] 822 Laparoscopic ventral hernia repair 0.7%
Kirshtein et al.[16] 103 Laparoscopic incisional hernia repair 2%
Petersen et al.[17] 121 Open incisional hernia repair 7%
Cobb et al.[18] 95 Open incisional hernia repair 8%

There is no consensus in the literature as to whether the use of non-absorbable mesh for incisional hernia repair is contraindicated in potentially contaminated surgical settings. Recently published data have indicated that the rate of mesh-related infections is comparable for ‘clean’ surgical procedures and for cases where potentially contaminated surgical procedures, such as appendectomy, cholocystectomy or enterectomy, are performed at the same time as incisional hernia repair [23,24].

The influence of mesh type on the incidence of infection was investigated in a recent study; the results showed that the use of multifilament polyester mesh resulted in a higher incidence of infection, small bowel obstruction and enterocutaneous fistula formation than the use of other types of mesh (knitted monofilament polypropylene, polytetrafluoroethylene or woven polypropylene) [19]. In addition, studies in experimental animals have shown that microporous mesh is associated with higher rates of infection and/or development of seromas, whereas macroporous mesh is associated with a higher incidence of adhesive and erosive events. Microporous mesh has a pore diameter of 10 µm, with the result that bacteria can penetrate the mesh, but polymorphonuclear leukocytes (with a diameter of 75 µm) cannot. This means that the bacteria in the mesh are protected from immunological defence mechanisms [25–27].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Clinical symptoms and signs
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
The reported interval between hernia repair and the manifestation of a mesh infection ranges from 2 weeks to 39 months [28]. Patients usually present with symptoms and signs of local acute inflammation (a combination of pain, erythema, tenderness, swelling and increased temperature in the abdominal wall in the area of the mesh). In addition, patients may have systemic manifestations such as fever, malaise, chills or rigors. A mesh-related infection can sometimes manifest with a discharging fistula, or with an intra-abdominal abscess. Rare cases of patients who presented with osteomyelitis following inguinal hernia surgery with implantation of a polypropylene mesh have been reported [29].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Microbiology
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
The usual causative organisms associated with cases of mesh infection are Staphylococcus spp., especially Staphylococcus aureus, Streptococcus spp. (including group B streptococci), Gram-negative bacteria (mainly Enterobacteriaceae), and anaerobic bacteria (including Peptostreptococcus spp.) [28]. In a study of mesh-related infections following incisional herniorrhaphy, 63% of the microorganisms isolated were methicillin-resistant S. aureus (MRSA) [18]. Rarely, mesh infections are caused by Candida spp. or Mycobacterium spp. [30,31].

Mesh infections can manifest with chronic, persistent or recurrent symptoms and signs. The infecting agents in some of these reported cases were small-colony variants, usually of S. aureus. The main characteristic of these infections is that they respond poorly to antimicrobial treatment regimens [32].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Prevention
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
The most important point regarding the prevention of mesh-related infections is that foreign body reactions depend on the amount of the prosthesis (mesh) used. For this reason, surgeons should try to minimise the area of mesh that is introduced during the hernia operation, since the inserted foreign material is an ideal medium for bacterial colonisation [33].

In addition, four main approaches to the prevention of mesh infection have been used. First, the wound can be rinsed with an antibiotic-containing solution, starting immediately after the dissection of the hernia sac, and then intermittently until the skin is sutured. It has been shown in an animal model that this approach inhibits the adhesion of bacteria to the surface of the mesh, as well as their growth [34]. Moreover, in a randomised trial of 162 patients who underwent inguinal hernia repair, there were no wound infections following the application of a single dose of cefamandole directly to the wound [35]. However, the effectiveness of lavage with solutions containing antimicrobial agents is controversial, since antibiotics require a defined duration of contact with pathogens, while lavage is usually a more rapid process.

A second approach involves the use of material placed in front of the mesh to slowly deliver an antimicrobial agent locally. In a randomised trial, the use of gentamicin-laced collagen tampons was tested in 301 patients undergoing prosthetic groin hernia repair. The collagen tampons were placed in front of the mesh before the aponeurosis of the external oblique muscle was sutured. This new technique resulted in fewer post-operative infections in comparison with 294 patients undergoing surgical repair for the same hernia without the use of gentamicin-containing collagen tampons [36].

Third, a mesh containing embedded antimicrobial agents can be used. Such a mesh is thought to help prevent bacterial adhesion and colonisation when implanted in wounds, with a subsequent reduced likelihood of post-operative infections.

Finally, traditional intravenous perioperative administration of antimicrobial agents can be used. Although hernia repair operations are classified as clean surgery, the administration of intravenous antibiotics perioperatively has been shown to be beneficial if a prosthetic material (mesh) is involved [37,38].

All of the above-mentioned strategies seem to be beneficial in reducing the incidence of mesh-related infection after hernia repair. However, no definitive recommendation can be made in favour of any particular approach in the absence of comparative outcome data. The current standard preventive strategy for other types of surgery, i.e., the perioperative administration of appropriate intravenous antibiotics, may be used until new data regarding alternative preventive strategies become available. At the present time, additional strategies to prevent mesh-related infections, such as the use of gentamicin-laced collagen tampons with a mesh, are best reserved for patients at high risk of infection, such as diabetic and obese patients.
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Diagnosis and treatment
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
A clinician should strongly consider the possibility of a mesh-related infection in any patient who presents with fever of unknown aetiology, symptoms and/or signs of inflammation of the abdominal wall in the area of the mesh, or other less common clinical manifestations of mesh infection, such as an enterocutaneous fistula or abdominal abscess in the area of the mesh.

Imaging techniques, including ultrasound and/or computerised tomography, can be useful for the diagnosis of mesh infection. Such techniques usually reveal an area of inflammation in the subcutaneous fat around the mesh, which has different echogenic or density characteristics, respectively, from that in other conditions, such as seroma. Additionally, the results of these imaging tests can indicate the presence of a fistula or an abscess.

It is important that no attempt should be made to perform a diagnostic paracentesis of mesh-related seromas when there are no symptoms and/or signs of inflammation of the abdominal wall. This is because of the real possibility of introduction of bacteria into the area of seroma during paracentesis, leading to the transformation of an aseptic reaction into an infectious process.

When a mesh-related infection occurs, a combined medical and surgical approach involving intravenous antimicrobial agents and complete surgical removal of the mesh is the preferred management strategy. For a variety of reasons, monotherapy with intravenous antibiotics generally has a poor outcome. The most important of these reasons relates to the fibroblastic response of the organism to the polymer of the implanted mesh, which results in the development of a thick fibrous capsule surrounding the mesh. Consequently, when an infection is established, this capsule restricts the penetration of antimicrobial agents into the infected mesh. In addition, it is well known that Staphylococcus spp., which are the most common causative organisms in mesh infections, produce a biofilm on the prosthesis, with the result that the microorganisms are protected simultaneously from antibiotics and the immune responses of the host organism [39].

Incomplete removal of the mesh should be suspected in any case with persistent or recurrent symptoms and/or signs of mesh infection. However, the results of a recent study suggested that the management of infected mesh might differ according to the type of mesh used. Specifically, it was suggested that infection of polyester or polypropylene mesh might be managed with drainage and antimicrobial agents only, whereas the infected mesh should be surgically removed in cases of infection involving expanded polytetrafluoroethylene mesh [17].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Conclusions
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
Clinicians should promptly consider the possibility of mesh infection in any patient who has undergone hernia repair surgery involving a mesh, and who has fever of unknown aetiology or symptoms and/or signs of infection of the abdominal wall. There is no adequate evidence in the literature concerning the specific risk factors for such infections. Whether the surgical technique used for the repair of a hernia or the precise type of implanted mesh influences the rate of development of a mesh-related infection remains to be clarified.

As yet, there are no published reports of comparative trials of different antimicrobial regimens for the management of mesh-related infections. Consequently, no definitive recommendations can be made concerning the preferred medical management strategy. However, given the known facts regarding the microbial aetiology of mesh-related infections, and the pathogenesis and characteristics of infections involving other types of prosthetic material, antimicrobial agents used for the treatment of mesh-related infection should at least include coverage for Staphylococcus spp.

Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
References
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
1Hesselink VJ, Luijendijk RW, De Wilt JH, Heide R, Jeekel J. An evaluation of risk factors in incisional hernia recurrence. Surg Gynecol Obstet 1993; 176: 228–234.PubMed,ChemPort,Web of Science® Times Cited: 1942Luijendijk RW, Hop WC, Van Den Tol MP et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000; 343: 392–398.DOI: 10.1056/NEJM200008103430603CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 3213Schumpelick V, Conze J, Klinge U. Preperitoneal mesh-plasty in incisional hernia repair. A comparative retrospective study of 272 operated incisional hernias. Der Chirurg 1996; 67: 1028–1035.DOI: 10.1007/s001040050099CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 814Vrijland WW, Van Den Tol MP, Luijendijk RW et al. Randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia. Br J Surg 2002; 89: 293–297.DOI: 10.1046/j.0007-1323.2001.02030.xDirect Link:AbstractPDF(77K)References5Klosterhalfen B, Hermanns B, Rosch R, Junge K. Biological response to mesh. Eur Surg 2003; 35: 16–20.DOI: 10.1046/j.1563-2563.2003.03011.xDirect Link:AbstractFull Article (HTML)PDF(617K)References6Jenkins SD, Klamer TW, Parteka JJ, Condon RE. A comparison of prosthetic materials used to repair abdominal wall defects. Surgery 1983; 94: 392–398.PubMed,ChemPort,Web of Science® Times Cited: 1377Butler CE, Navarro FA, Orgill DP. Reduction of abdominal adhesions using composite collagen–GAG implants for ventral hernia repair. J Biomed Mater Res 2001; 58: 75–80.Direct Link:AbstractFull Article (HTML)PDF(376K)References8Debodinance P, Delporte P, Engrand JB, Boulogne M. Development of better tolerated prosthetic materials: applications in gynecological surgery. J Gynecol Obstet Biol Reprod (Paris) 2002; 31: 527–540.PubMed,ChemPort9Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze J, Schumpelick V. Impact of polymer pore size on the interface scar formation in a rat model. J Surg Res 2002; 103: 208–214.DOI: 10.1006/jsre.2002.6358CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 6410Arroyo A, Garcia P, Perez F, Andreu J, Candela F, Calpena R. Randomized clinical trial comparing suture and mesh repair of umbilical hernia in adults. Br J Surg 2001; 88: 1321–1323.DOI: 10.1046/j.0007-1323.2001.01893.xDirect Link:AbstractPDF(57K)References11Grant AM. Open mesh versus non-mesh repair of groin hernia: meta-analysis of randomised trials based on individual patient data [corrected]. Hernia 2002; 6: 130–136.DOI: 10.1007/s10029-002-0073-1CrossRef,PubMed,ChemPort12Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer EA, Troidl H. Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. Br J Surg 2002; 89: 50–56.DOI: 10.1046/j.0007-1323.2001.01974.xDirect Link:AbstractPDF(87K)References13White TJ, Santos MC, Thompson JS. Factors affecting wound complications in repair of ventral hernias. Am Surg 1998; 64: 276–280.PubMed,ChemPort,Web of Science® Times Cited: 7614Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic ventral and incisional hernia repair in 407 patients. J Am Coll Surg 2000; 190: 645–650.DOI: 10.1016/S1072-7515(00)00280-5CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 15015Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg 2003; 238: 391–399.PubMed,Web of Science® Times Cited: 18516Kirshtein B, Lantsberg L, Avinoach E, Bayme M, Mizrahi S. Laparoscopic repair of large incisional hernias. Surg Endosc 2002; 16: 1717–1719.DOI: 10.1007/s00464-001-9200-9CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 2417Petersen S, Henke G, Freitag M, Faulhaber A, Ludwig K. Deep prosthesis infection in incisional hernia repair: predictive factors and clinical outcome. Eur J Surg 2001; 167: 453–457.DOI: 10.1080/110241501750243815Direct Link:AbstractPDF(66K)18Cobb WS, Harris JB, Lokey JS, McGill ES, Klove KL. Incisional herniorrhaphy with intraperitoneal composite mesh: a report of 95 cases. Am Surg 2003; 69: 784–787.PubMed,Web of Science® Times Cited: 3219Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg 1998; 133: 378–382.DOI: 10.1001/archsurg.133.4.378CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 27620McGreevy JM, Goodney PP, Birkmeyer CM, Finlayson SR, Laycock WS, Birkmeyer JD. A prospective study comparing the complication rates between laparoscopic and open ventral hernia repairs. Surg Endosc 2003; 17: 1778–1780.DOI: 10.1007/s00464-002-8851-5CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 4921Carbajo MA, Martin del Olmo JC, Blanco JI et al. Laparoscopic treatment vs open surgery in the solution of major incisional and abdominal wall hernias with mesh. Surg Endosc 1999; 13: 250–252.CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 13222Chari R, Chari V, Eisenstat M, Chung R. A case controlled study of laparoscopic incisional hernia repair. Surg Endosc 2000; 14: 117–119.PubMed,ChemPort,Web of Science® Times Cited: 4323Geisler DJ, Reilly JC, Vaughan SG, Glennon EJ, Kondylis PD. Safety and outcome of use of nonabsorbable mesh for repair of fascial defects in the presence of open bowel. Dis Colon Rectum 2003; 46: 1118–1123.CrossRef,PubMed,Web of Science® Times Cited: 2124Birolini C, Utiyama EM, Rodrigues AJ, Birolini D. Elective colonic operation and prosthetic repair of incisional hernia: does contamination contraindicate abdominal wall prosthesis use? J Am Coll Surg 2000; 191: 366–372.CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 2425Amid PK. Classification of biomaterials and their related complications in abdominal wall hernia surgery. Hernia 1997; 1: 15–21. CrossRef26Bellon JM, Bujan J, Contreras L, Hernando A, Jurado F. Macrophage response to experimental implantation of polypropylene prostheses. Eur Surg Res 1994; 26: 46–53.CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 3727Walker AP, Henderson J, Condon RE. Double-layer prostheses for repair of abdominal wall defects in a rabbit model. J Surg Res 1993; 55: 32–37.DOI: 10.1006/jsre.1993.1104CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 2828Taylor SG, O'Dwyer PJ. Chronic groin sepsis following tension-free inguinal hernioplasty. Br J Surg 1999; 86: 562–565.DOI: 10.1046/j.1365-2168.1999.01072.xDirect Link:AbstractPDF(53K)References29Due SS, Billesbolle P, Hansen MB. Osteomyelitis. A rare and serious complication of inguinal hernia surgery. Ugeskr Laeger 2001; 163: 3230–3231.PubMed,ChemPort30Nolla-Salas J, Torres-Rodriguez JM, Grau S et al. Successful treatment with liposomal amphotericin B of an intraabdominal abscess due to Candida norvegensis associated with a Gore-Tex mesh infection. Scand J Infect Dis 2000; 32: 560–562.DOI: 10.1080/003655400458893CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 231Matthews MR, Caruso DM, Tsujimura RB, Smilack JD, Pockaj BA, Malone JM. Ventral hernia synthetic mesh repair infected by Mycobacterium fortuitum. Am Surg 1999; 65: 1035–1037.PubMed,ChemPort,Web of Science® Times Cited: 1232Goring H, Waldner H, Emmerling P, Abele-Horn M. Chronic fistulating wound infection after Lichtenstein repair of inguinal hernia, caused by a small colony variant of Staphylococcus aureus. Der Chirurg 2001; 72: 441–443.DOI: 10.1007/s001040051328CrossRef,ChemPort,Web of Science® Times Cited: 533Deysine M. Pathophysiology, prevention, and management of prosthetic infections in hernia surgery. Surg Clin North Am 1998; 78: 1105–1115.CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 2534Troy MG, Dong QS, Dobrin PB, Hecht D. Do topical antibiotics provide improved prophylaxis against bacterial growth in the presence of polypropylene mesh? Am J Surg 1996; 171: 391–393.DOI: 10.1016/S0002-9610(97)89616-XCrossRef,PubMed,ChemPort,Web of Science® Times Cited: 1835Lazorthes F, Chiotasso P, Massip P, Materre JP, Sarkissian M. Local antibiotic prophylaxis in inguinal hernia repair. Surg Gynecol Obstet 1992; 175: 569–570.PubMed,ChemPort,Web of Science® Times Cited: 3636Musella M, Guido A, Musella S. Collagen tampons as aminoglycoside carriers to reduce postoperative infection rate in prosthetic repair of groin hernias. Eur J Surg 2001; 167: 130–132.DOI: 10.1080/110241501750070592Direct Link:AbstractPDF(139K)37Yerdel MA, Akin EB, Dolalan S et al. Effect of single-dose prophylactic ampicillin and sulbactam on wound infection after tension-free inguinal hernia repair with polypropylene mesh: the randomized, double-blind, prospective trial. Ann Surg 2001; 233: 26–33.DOI: 10.1097/00000658-200101000-00005CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 5238Celdran A, Frieyro O, De La Pinta JC et al. The role of antibiotic prophylaxis on wound infection after mesh hernia repair under local anesthesia on an ambulatory basis. Hernia 2004; 8: 20–22.DOI: 10.1007/s10029-003-0164-7CrossRef,PubMed39Buret A, Ward KH, Olson ME, Costerton JW. An in vivo model to study the pathobiology of infectious biofilms on biomaterial surfaces. J Biomed Mater Res 1991; 25: 865–874.
http://onlinelibrary.wiley.com/doi/10.1111/j.1469-0691.2004.01014.x/full

Thursday, June 30, 2011

PATTEN v. GAYLE Trocar Injury

PATTEN v. GAYLE
CHARLOTTE M. PATTEN, ET AL., Plaintiff-Appellant,v.CHRISTOPHER GAYLE, M.D., Defendant-Appellee.
No. 46,453-CA.
Court of Appeals of Louisiana, Second Circuit.

June 22, 2011.

NELSON & HAMMONS, A Professional Law Corporation, John L. Hammons, James Paul Lambert, Annis Cornell Flournoy, Counsel for Appellant.
WATSON, BLANCHE, WILSON & POSNER, Peter T. Dazzio, Garrett S. Callaway, Counsel for Appellee.
Before GASKINS, PEATROSS and DREW, JJ.

--------------------------------------------------------------------------------




DREW, J.:
The primary issue is whether the jury erred in finding the doctor's negligence during surgery did not cause any injury to the patient. Charlotte Patten and her husband, Rodney L. Patten, appeal the judgment rejecting their demands and dismissing the action with prejudice. They also seek review of the trial court's denial of their motion for judgment notwithstanding the verdict ("JNOV"). For the reasons discussed herein, the judgment1 is reversed in part and affirmed in part and rendered, awarding plaintiffs a portion of the damages sought.
FACTUAL AND PROCEDURAL BACKGROUND
Charlotte Patten became a patient of Dr. Christopher Gayle, an OB-GYN at Willis-Knighton Pierremont, in 1997 when Dr. Gayle performed a total abdominal hysterectomy, leaving her ovaries in place. In early 2001, Mrs. Patten began suffering from pain in her lower right abdomen which Dr. Gayle suspected was a cystic lesion on her right ovary. On August 14, 2001, at Willis-Knighton Pierremont, Mrs. Patten was admitted for laparoscopic2 evaluation and possible removal of her ovaries.
Dr. Gayle, assisted by Dr. Mary Taylor, began the procedure by inflating the abdominal cavity with carbon dioxide in order to create space between the abdominal wall and internal organs. Once the cavity was inflated, Dr. Gayle inserted an operative trocar3 through the umbilicus.
The operative trocar blade is covered with a protective sheath. When the doctor applies pressure to the trocar, the blade is unsheathed, allowing the trocar to penetrate the skin, muscle, and fascia. Once the trocar encounters "empty space" in the body cavity, the sheath re-covers the blades and locks in place. Since the initial trocar insertion is performed blind, most laparoscopic injuries occur during this part of the procedure.4 In this case, Dr. Gayle inserted the first trocar without complication.
After removing the blade from the trocar tube, Dr. Gayle inserted a laparoscope into this first trocar to allow him to see the inside of the abdominal cavity. Dr. Gayle noted adhesions of the small bowel to the abdominal wall. Because he was unable to determine whether he would be able to proceed laparoscopically, Dr. Gayle intended to insert a second trocar so he could better visualize the ovaries and abdominal cavity.
After using the laparoscope in the first trocar to find an area that was free of adhesions, Dr. Gayle testified he tried to angle the second trocar so it would enter the abdominal cavity in a particular direction. The second trocar unexpectedly entered the patient's abdomen. The doctor claimed the amount of force he applied should not have been sufficient for the trocar to enter the abdomen. The second trocar entered the abdomen in a different direction than Dr. Gayle intended and came out near a bowel adhesion.
Although Dr. Gayle could see the tip of the trocar, he could not determine whether the trocar had penetrated or avoided the bowel. Dr. Gayle left the second trocar tube in place but removed the blade. He then inserted a third trocar (without incident) and placed the laparoscope into the third trocar to evaluate the bowel. Dr. Gayle observed no bleeding or bowel content but was still unable to determine whether the bowel had been punctured.
Dr. Gayle decided he needed to open the patient's abdomen because there were numerous adhesions of the bowel to the abdominal wall. The doctor also concluded that the right ovary, which was cystic and densely adhered to the pelvic wall, needed to be removed, a procedure that could not be performed laparoscopically. Finally, he was still concerned about the possibility of bowel injury by the second trocar.
After making a Pfannenstiel incision5 and lysing6 some of the adhesions of the bowel from the abdominal wall, Dr. Gayle saw the second trocar had penetrated Mrs. Patten's small bowel "through and through." Dr. Gayle brought approximately 20 inches of bowel out of the abdominal cavity and called for Dr. Craig Bozeman, a general surgeon, to perform emergency surgery to remove the trocar7 and repair the bowel.8
Dr. Bozeman decided to connect the two holes to facilitate the surgical repair. He did so by cutting across the circumference of the bowel between the two holes. After sewing up the bowel, Dr. Bozeman "ran the bowel"9 to inspect it and found the repair was effective (not leaking) and that no further injuries could be seen. Dr. Gayle and Dr. Taylor then finished the surgery by removing Mrs. Patten's right ovary, placing the bowel back inside the abdomen and closing the incisions.
After the operation, Mrs. Patten was kept under observation by Dr. Bozeman to ensure her bowel was causing no further problems. Over the next few days, she showed some signs of improvement in her gastrointestinal functions but also had indications of trouble, most notably swelling. Five days after the operation, Mrs. Patten was examined by Dr. Schwalke, who was on call for Dr. Bozeman. That morning, Mrs. Patten's abdomen was distended. Later that day, feculent material began exuding from her incision.
Dr. Schwalke performed emergency exploratory surgery, which required him not only to reopen her horizontal incision but to make a vertical "midline" incision up to the sternum. He discovered a 3mm perforation of the bowel two inches from where the bowel had been repaired by Dr. Bozeman five days earlier. Also, approximately three liters of feculent material was in Mrs. Patten's abdominal cavity, necessitating extensive cleaning and drainage.
As a result of the feculent material having leaked into her abdominal cavity, Mrs. Patten developed peritonitis (an abdominal infection) and pneumonia. She was hospitalized until August 30. Mrs. Patten has subsequently suffered from abscesses (some of which ruptured) and herniating of her incisions, both of which have required further surgeries, and additional medical problems.
On June 6, 2002, Mrs. Patten and her husband filed a petition for a medical review panel against Dr. Gayle, Dr. Taylor, and Dr. Bozeman. The Pattens alleged negligence against the three doctors with respect to the August 14 surgery performed by Dr. Gayle and Dr. Taylor, in which Mrs. Patten's bowel was penetrated by a trocar, and Dr. Bozeman's emergency surgical repair.
The medical review panel (composed of Dr. Daniel Carroll, Dr. Edwin Byrd, and Dr. Timothy Hart) ruled that the evidence did not support the conclusion that Dr. Gayle, Dr. Taylor, or Dr. Bozeman failed to meet the applicable standards of care. Specifically, the panel found no evidence indicating the perforation discovered by Dr. Schwalke was present on August 14 and missed by Dr. Bozeman during his repair. The panel concluded that this perforation was most likely the result of undetectable microvascular damage that was unrelated to the trocar injury. Further, the panel opined that Dr. Gayle did not "lose control" of the trocar because there are many factors10 outside of the surgeon's control that can affect the passage of the trocar through the abdomen.11
On February 6, 2004, Mrs. Patten, together with her husband, filed a medical malpractice suit against Dr. Gayle.12 Following a four-day jury trial on the merits in May 2010, the jury returned a verdict that Dr. Gayle had deviated from the applicable standard of care and had committed malpractice.13 The jury, however, found Dr. Gayle's negligence had not caused any injury that would otherwise not have been incurred by Mrs. Patten. Finding a lack of causation, the jury awarded no damages to Mrs. Patten or her husband. At the request of counsel, the jury was polled, revealing the jury was split 10-2.
Following entry of the judgment denying plaintiffs' recovery and dismissing the action at their cost, Mrs. Patten and her husband moved for a JNOV, arguing the jury's finding that Dr. Gayle's negligence caused no injuries was manifestly erroneous. Following a hearing, the trial court denied the motion, finding the jury's verdict was reasonable, and entered judgment accordingly on August 27, 2010.
Mrs. Patten and her husband appealed, arguing: (1) the jury manifestly erred in finding a lack of causation; (2) the trial judge manifestly erred in denying the motion for JNOV; and (3) the jury erred in failing to award damages.
DISCUSSION
In a medical malpractice action, the plaintiff has the burden of proving: (1) the applicable standard of care, (2) that the standard of care was breached, and (3) that as a proximate result of the breach the plaintiff sustained injuries that would not otherwise have been incurred. La. R.S. 9:2794(A). The third element, causation, is subject to the manifest error standard of review. Lovelace v. Giddens, 31,493 (La. App. 2d Cir. 2/24/99), 740 So.2d 652, writ denied. Under the manifest error standard, an appellate court cannot substitute its own inferences and conclusions about the facts. Johnson v. Morehouse GeneralHosp., 2010-0387 (La. 5/10/11), 2011 WL 1759932; Wooley v. Lucksinger, 2009-0571 (La. 4/1/11), 2011 WL 1205136. Findings of fact cannot be set aside or overturned by the appellate court unless they are clearly wrong. Johnson, supra. Factual conclusions are not clearly wrong when the factfinder chooses a view of the evidence that an appellate court disagrees with as long as the factfinder's view is permissible. Id. Manifest error occurs only when there is "no reasonable factual basis for the [factfinder's] conclusion[.]" Johnson, 2010-0387 at p. 6. In a medical malpractice claim, great deference should be given to the factfinder when medical experts express different opinions relevant to causation. Lovelace, supra.
Initial Trocar Injury
While recognizing that Mrs. Patten suffered injuries, the Medical Review Panel unanimously found that Dr. Gayle was not negligent. In its written reasons, the panel stated there were other factors outside of Dr. Gayle's control that could have caused the second trocar to become misdirected, including scarring of the abdominal wall, defects from her prior surgeries and differences in the degree of sharpness of trocars.
Dr. Robert Zurawin, a board-certified OB-GYN and an associate professor at Baylor Medical School, testified by affidavit, deposition, and at trial on behalf of Mrs. Patten. Disagreeing with the medical review panel, Dr. Zurawin believed Dr. Gayle was negligent. Dr. Zurawin stated the factors mentioned by the review panel were relevant only to a blind trocar insertion. Since Dr. Gayle had already inserted one trocar, he should have been able to see (and thus avoid) any problems inside the abdominal cavity. At trial, Dr. Zurawin testified the trocar must have penetrated bowel that was adhered to the abdominal wall. Otherwise the protective sheath would have covered the blade after entering the abdomen and the through-and-through puncture never would have occurred.
Dr. Zurawin also noted that Dr. Gayle had apparently been holding the second trocar improperly. In his deposition, Dr. Gayle indicated he was not yet holding the second trocar in the proper position when it penetrated the abdomen. Dr. Zurawin testified the way Dr. Gayle was holding the trocar contributed to the trocar penetrating the abdomen without Dr. Gayle intending it to as well as how deep it penetrated. Further, Dr. Zurawin believed the second trocar should never have been inserted because Dr. Gayle should have converted to an open surgery once he saw the numerous, dense adhesions through the laparoscope in the first trocar.
Dr. Gayle admitted the puncture of the bowel by the second trocar was an injury. In his original answer to the complaint, Dr. Gayle stated that Dr. Bozeman was called in for "repair of a bowel injury." Moreover, at trial, Dr. Gayle admitted on cross-examination that Mrs. Patten "was injured and she suffered as a result of that injury[.]" Dr. Gayle claimed that the trocar injury was insignificant as far as the medical malpractice claim was concerned.
Dr. Gayle relied upon the testimony of Dr. Taylor, Dr. Schwalke, and Dr. Byrd, each of whom testified the initial bowel injury from the second trocar was insignificant. Both Dr. Taylor and Dr. Byrd testified the only harm done to Mrs. Patten was having approximately an extra hour of surgery by Dr. Bozeman to repair the bowel. Dr. Schwalke testified similarly, stating the injury was insignificant because it was immediately recognized and repaired and there were no further damages resulting from that injury.
Dr. Gayle also relied upon two consent forms that Mrs. Patten signed prior to the surgery. When obtaining consent from a patient for any treatment or procedure, physicians have a duty to advise the patient of associated risks. Roberts v. Cox, 28,094 (La. App. 2d Cir. 2/28/96), 669 So.2d 633; Broadway v. St. Paul Ins. Co., 22,433 (La. App. 2d Cir. 1991), 582 So.2d 1368. A physician does not have to inform a patient of "every conceivable possibility" but only "those that can reasonably be anticipated." Steinbach v. Barfield, 428 So.2d 915 (La. App. 1st Cir. 1983) (reversed on other grounds); see also, Roberts, supra; Broadway, supra.
A risk of bowel injury was among the risks listed on the consent forms signed by Mrs. Patten. Dr. Hart testified at trial that this risk would include bowel injury due to a misdirected trocar. Dr. Hart also testified, however, that a patient never consents to negligent treatment. This court agrees. Consent forms should not shield physicians and other healthcare providers from liability for injuries caused by their negligence simply because the injuries are a known risk of the procedure. While patients can be held to reasonably anticipate that procedures carry certain risks that may occur without any fault from their physician, patients should also reasonably anticipate a physician will not negligently injure them. Being injured as a result of negligence by one's physician is not a reasonably foreseeable risk of receiving medical treatment.
The through-and-through perforation of Mrs. Patten's bowel was undoubtedly an injury. Downplaying the significance of the injury is a defense to damages but not a defense to the injury actually having occurred. The two consent forms signed by Mrs. Patten do not exonerate Dr. Gayle for negligently injuring her by puncturing her bowel with the second trocar. Therefore, the jury's finding that Dr. Gayle's negligence caused no injury to Mrs. Patten is manifestly erroneous with respect to the trocar's penetration of the bowel. As a result, this court reviews the merits of this issue de novo.
De Novo Review of the Merits — Initial Trocar Injury
Dr. Gayle negligently punctured Mrs. Patten's bowel with a trocar, necessitating the emergency repair by Dr. Bozeman. According to Dr. Gayle, aside from the repair of the punctured bowel, all other surgical steps taken on August 14 would have been required even if there had been no bowel injury.
First, Dr. Gayle stated in his deposition that Mrs. Patten had to be "opened up" in order to remove her ovary. Therefore, the decision to open her abdomen would have been made even if there were no bowel injury. This view was shared by Dr. Taylor. Even Dr. Zurawin agreed, stating in his affidavit that Mrs. Patten should have been opened up after Dr. Gayle viewed Mrs. Patten's numerous abdominal adhesions through the laparoscope in the first trocar.
Second, Dr. Gayle testified the bowel adhesions had to be lysed from the abdominal wall in order to remove the right ovary. Both Dr. Schwalke and Dr. Hart agreed that lysing the adhesions would have been necessary without the trocar injury. Moreover, even had the trocar injury been the sole reason for lysing the bowels, Dr. Zurawin testified that Dr. Gayle did not breach the applicable standard of care by lysing the bowel adhesions to prepare for the surgical repair of the bowel injury by Dr. Bozeman.
Third, Dr. Zurawin stated in his deposition that it is within the applicable standard of care to run the bowel after lysing any bowel adhesions to ensure it has not been injured. Therefore, the bowel would necessarily have been run whether or not the trocar repair was performed.
Fourth, Dr. Gayle stated in his motion in limine to exclude medical expenses that, even without the trocar injury, Mrs. Patten would have stayed in the hospital a few days following the surgery for observation. Dr. Gayle stated this was necessary because having to lyse her bowel adhesions created a possibility of a perforation developing.
In contrast, Dr. Zurawin stated in his affidavit that, but for the trocar injury to the bowel, Mrs. Patten would not have undergone the repair procedure which placed her at a greater risk of a subsequent bowel perforation. However, Dr. Zurawin acknowledged that Dr. Gayle had to open Mrs. Patten up and lyse the bowel adhesions to complete his surgery whether or not there had been a bowel injury.
Aside from the repair of the through-and-through bowel puncture, all other treatments and steps taken (opening her up, lysing the adhesions, etc.) would have been necessary even had there been no bowel injury and therefore were not causally related to Dr. Gayle's negligence. The only injuries Mrs. Patten suffered on August 14, 2001, that were causally connected to Dr. Gayle's negligent handling of the second trocar and would not otherwise have been incurred are: (1) the puncture of the bowel; and (2) the time and expense of Dr. Bozeman repairing the bowel.
Subsequent Perforation
The cause of the subsequent perforation that was discovered by Dr. Schwalke five days after Mrs. Patten's first operation was the primary topic throughout this case. In Dr. Gayle's opinion, this subsequent perforation was most likely the result of a microvascular injury that was undetectable at the time of Dr. Bozeman's repair. The medical review panel had a similar opinion, finding the perforation was unrelated to the initial trocar injury and most likely the result of microvascular damage.
Dr. Zurawin stated in his affidavit that while the cause of the perforation was "not clear," he believed it was most likely caused directly by the second trocar striking a loop of bowel after making its through-and-through puncture. Dr. Hart, Dr. Bozeman, and Dr. Schwalke all testified that the trocar tip could have directly harmed another section of bowel, causing damage that eventually led to the subsequent perforation. Dr. Hart qualified his testimony, stating this scenario was highly unlikely.
Both Dr. Gayle and Dr. Taylor testified the trocar penetrated the abdomen in an area where there was an upside-down "U-shaped" section of bowel hanging from the abdominal wall. Thus, according to the only two people who saw the location of the bowel before Mrs. Patten was opened up, there was no other portion of bowel for the trocar to damage. Assuming the bowel was adhered in this position, Dr. Byrd testified it would have been "spectacular" for the tip of the second trocar to have directly injured another part of the bowel.
Moreover, the bowel was run and inspected by Dr. Bozeman after he repaired the initial puncture. This inspection was done in the presence of both Dr. Gayle and Dr. Taylor. Dr. Bozeman testified he examined a significant portion of the surrounding bowel. The perforation that was found five days later was only two inches from the repair site. Dr. Hart testified it would be almost impossible for Dr. Bozeman, Dr. Gayle, and Dr. Taylor all to have missed any visible injury to the bowel that was only two inches away from the site of the trocar puncture.
In addition, the opinion of the review panel was that the timeline indicated the perforation was not present on August 14. The panel opinion was supported by both Dr. Hart's and Dr. Schwalke's testimony that the perforation likely opened two or three days after Dr. Gayle's operation, based on when Mrs. Patten began having swelling problems and the amount of feculent material found in her abdominal cavity. Dr. Zurawin disagreed, stating in his deposition that a small perforation might have taken five days to manifest and therefore the timeline was not definitive.
In view of all the evidence presented, it seems unlikely the trocar tip directly caused damage to the bowel that led to the subsequent perforation. However, Mrs. Patten also presented evidence of another theory: that the trocar injury indirectly caused the perforation because it led to the bowel sustaining a partial thickness injury14 which ruptured in the days following Dr. Gayle's surgery. This partial thickness injury could have been caused either when the adhesions were lysed from the abdominal wall or when Dr. Bozeman was performing his repair of the initial trocar injury.
Dr. Carroll stated in his deposition that any partial thickness injury caused by Dr. Bozeman repairing and running the bowel should have occurred immediately adjacent to the original injury. Since the perforation was two inches away from the original injury, Dr. Carroll stated it was highly unlikely Dr. Bozeman's repair caused the perforation. Additionally, none of the medical experts who testified believed that either repairing or running the bowel indirectly caused the perforation
Dr. Schwalke testified that the most likely cause of the perforation was a partial thickness injury that occurred when the bowel adhesions were lysed from the abdominal wall. Both Dr. Hart and Dr. Byrd also agreed the cause of the perforation was most likely a partial thickness injury due to lysing adhesions. According to Dr. Gayle, the portion of bowel where the perforation occurred was adhered to the abdominal wall, making it more susceptible to a partial thickness injury. Dr. Bozeman testified that a partial thickness injury is a known risk of having to lyse bowel adhesions.
In his deposition, Dr. Zurawin stated it was within the applicable standard of care for Dr. Gayle to lyse the bowel adhesions. Dr. Zurawin also noted that it was unclear whether Dr. Gayle or Dr. Bozeman lysed the bowel that was two inches away from the trocar injury. Therefore, assuming the lysing of the bowel caused a partial thickness injury, it would be impossible to know to whom to attribute it. Moreover, even if the lysing caused an undetectable injury, Dr. Zurawin testified there would not have been a breach of any standard of care by Dr. Gayle.
The medical experts were in agreement that the bowel adhesions necessarily had to be lysed in order to remove Mrs. Patten's right ovary. Therefore, had no trocar injury ever occurred, the bowel adhesions would nonetheless have been lysed. This possibility was explicitly supported in the deposition testimony of all three members of the medical review panel (Dr. Byrd, Dr. Hart, Dr. Carroll) as well as the trial testimony of both Dr. Schwalke and Dr. Byrd.
Mrs. Patten had to be opened up and her adhesions had to be lysed. The evidence did not show that, more likely than not, the initial trocar injury was either a direct or indirect cause of the subsequent perforation and the resulting peritonitis and pneumonia which kept Mrs. Patten hospitalized until August 30, 2001. As Dr. Zurawin testified, the cause of this perforation is simply not clear "within a reasonable medical probability." Therefore, the jury finding no causation of damages with respect to the subsequent perforation is not manifestly erroneous.
Injuries Suffered by Mrs. Patten Since August 30, 2001
Mrs. Patten has suffered from many medical problems following her release on August 30, 2001, after recovering from peritonitis and pneumonia. She alleges that these subsequent injuries are traceable to Dr. Gayle's negligence. Among the injuries Mrs. Patten has suffered, according to her First Supplemental and Amending Petition:
abscesses . . . excruciating pain and suffering, mental anguish and embarrassment . . . extensive scarring, abdominal adhesions and extensive internal adhesions . . . and repeated surgical procedures[.]
Mrs. Patten also claims hernias of her incisions as an additional injury attributable to Dr. Gayle.
According to Mrs. Patten's own testimony, she had a history of abdominal pain and discomfort ever since the birth of her second child. Her first laparoscopic procedure was performed in 1993. She also had multiple abdominal surgeries performed prior to the surgery on August 14, 2001. As Dr. Zurawin stated in his deposition, the more surgeries a person has, the more likely she is to have bowel adhesions in the future that could lead to the injuries Mrs. Patten has suffered. Mrs. Patten also testified she had off-and-on undergone treatment for depression prior to Dr. Gayle's 2001 surgery.
In the months following the surgeries by Dr. Gayle and Dr. Schwalke, Mrs. Patten was treated by Dr. Bozeman for multiple abscesses of her surgical wounds. In his deposition, Dr. Bozeman stated these abscesses were likely not related to Mrs. Patten's peritonitis but rather a reaction to the sutures used by Dr. Schwalke.
In 2002, Mrs. Patten was treated by Dr. Charles Black for hernias of her incisions. Dr. Black's deposition was read at trial; he was unable to testify in person because he was suffering from health problems and subsequently died. In his deposition, Dr. Black stated that incisional hernias occur around 5% of the time even in the absence of negligence. Dr. Black further stated that, considering Mrs. Patten's history of abdominal surgeries, there was no reason to attribute her hernias in 2002 to either Dr. Gayle's or Dr. Schwalke's surgeries in 2001.
Dr. Dale McGinty treated Mrs. Patten for abdominal adhesions sporadically between 2005 and 2008. In his deposition, Dr. McGinty stated he had no reason to connect those adhesions to Dr. Gayle's surgery. Further, Dr. McGinty stated there was no way to know whether the adhesions he treated were caused by Dr. Gayle's surgery, any of Mrs. Patten's prior or subsequent abdominal surgeries.
Dr. Hart testified that hernias of the midline incision are traceable to Dr. Schwalke's surgery, as this was the first time such an incision had been made on Mrs. Patten. Hernias of any other incisions, though, are not necessarily connected to Dr. Gayle's surgery because any of Mrs. Patten's pre-2001 surgeries could have been the underlying cause.
After sitting on the medical review panel, Dr. Byrd testified in his deposition that it is hypothetically possible none of the injuries Mrs. Patten suffered are causally connected to Dr. Gayle. In other words, even had there been no trocar injury, it is possible that the subsequent bowel perforation would have occurred, that Mrs. Patten would develop an abdominal infection from the material leaking from the perforation, and that all of her hernias, abscesses, and adhesions might have occurred as anticipated risks of the surgeries performed by Dr. Gayle and Dr. Schwalke.
Having failed to show the subsequent perforation of her bowel was causally connected to Dr. Gayle's negligence, Mrs. Patten did not establish that injuries she has suffered since August 30, 2001, were caused by Dr. Gayle. Thus, the jury finding no causation of any damages with respect to Mrs. Patten's medical problems since August 30, 2001, is not manifestly erroneous.
Damages
The only injuries that Mrs. Patten has suffered as a result of Dr. Gayle's negligence are the puncture of her bowel by the second trocar and the time and expense of Dr. Bozeman repairing the bowel injury.
Dr. Gayle claimed the trocar injury itself was insignificant. Three medical experts (Dr. Taylor, Dr. Schwalke, and Dr. Byrd) also testified the injury was insignificant because it was immediately recognized, repaired, and no future harm resulted from it. Mrs. Patten presented no evidence showing the bowel injury from the second trocar caused any significant harm after its repair.
In his motion in limine to exclude certain medical expenses, Dr. Gayle argued the only medical expenses that were related to his August 14 surgery on Mrs. Patten are as follows: Dr. Gayle ($3,331.20); Willis-Knighton Pierremont ($18,546.85), Pierremont Anesthesia Consultants ($1,647.00), and Dr. Bozeman ($1,803.00), totaling $25,328.05.
Dr. Gayle's fee for the operation would have been incurred even without a bowel injury. Therefore, these expenses ($3,331.20) are not recoverable as damages.
Most of the expenses owed to Willis-Knighton Pierremont also would have been incurred even if there were no bowel injury. Some of the expenses, however, are causally connected to Dr. Gayle's negligence. Upon review of the Willis-Knighton medical bills, this court awards $1,726.00 owed to Willis-Knighton as damages attributable to Dr. Gayle negligently puncturing Mrs. Patten's bowel.
Mrs. Patten was placed under anesthesia for Dr. Gayle's surgery. However, additional anesthetic gases were necessary due to the extra time required for Dr. Bozeman to perform his repair. This court awards $1,281.00 in damages recoverable against Dr. Gayle for services performed by Pierremont Anesthesia Consultants.
The services performed by Dr. Bozeman were necessitated by the bowel injury and would not otherwise have been required. All expenses owed to Dr. Bozeman ($1,803.00) are causally connected to Dr. Gayle's negligence and recoverable as damages.
Accordingly, Mrs. Patten is awarded $4,811.00 in medical expenses attributable to injuries resulting from Dr. Gayle's negligence.
There is next the issue of general damages, such as pain and suffering, which cannot be definitively measured in monetary terms. See McGee v. A C and S, Inc., 2005-1036 (La. 7/10/06), 933 So.2d 770. Mrs. Patten claimed general damages for pain and suffering, mental anguish, disfigurement, and decreased quality of life. In closing arguments, counsel for plaintiff recommended general damages totaling $800,000 to Mrs. Patten as well as $250,000 to Mr. Patten for decreased quality of life and loss of consortium.
These claims all are connected to the perforation discovered by Dr. Schwalke and Mrs. Patten's subsequent medical problems, not the initial trocar injury. Because the jury did not manifestly err in finding Dr. Gayle's negligence was not the cause of the subsequent perforation, no general damages are warranted for these claims.
The claims for pain and suffering and mental anguish are compensable. While the majority of Mrs. Patten's pain and suffering and anguish are attributable to the subsequent perforation, the initial trocar injury also caused some general damages. Mrs. Patten testified at trial that the day of Dr. Gayle's surgery was her daughter's first day of school. Rather than going home that afternoon, as she expected, Mrs. Patten was hospitalized for a total of 16 days. When she awoke after the first surgery and was told by her husband that there was a problem, Mrs. Patten thought she had cancer. Mrs. Patten also testified she is now somewhat paranoid because Dr. Gayle was unable to explain what went wrong.
Accordingly, Mrs. Patten is awarded $10,000 in general damages for pain and suffering and mental anguish.
CONCLUSION
The portions of the final judgment concluding plaintiffs suffered no injuries from Dr. Gayle puncturing Mrs. Patten's bowel are manifestly erroneous and are reversed. Judgment is rendered awarding her special and general damages. In all other respects, the judgment is affirmed.
DECREE
The judgment of the trial court is REVERSED IN PART and AFFIRMED IN PART, and judgment is rendered in favor of appellants, awarding them the amount of $14,811.00. Appellee is cast with all costs of the appeal.

--------------------------------------------------------------------------------

Footnotes

--------------------------------------------------------------------------------

1. As a result of partially reversing the first judgment, consideration of the second judgment is unnecessary. The denial of the JNOV would, however, be affirmed and reversed along the same grounds.
Back to Reference
2. Laparoscopic surgery involves inserting small, hollow tubes, known as trocars, into the patient and operating by inserting scopes and instruments down the tubes. A small camera (laparoscope) can be inserted into these tubes for evaluation. Surgical instruments can also be inserted into trocars. A laparoscopy is a minimally invasive procedure because it does not involve "opening the patient up."
Back to Reference
3. An operative trocar is a trocar with a sharp blade at the tip. It is used for initial penetration of the trocar into the abdominal cavity.
Back to Reference
4. Dr. Robert Zurawin, medical expert for Mrs. Patten, testified that 95-98% of trocar-related injuries occur during insertion of the first trocar.
Back to Reference
5. A Pfannenstiel incision is a long horizontal abdominal incision, also called a "bikini" incision.
Back to Reference
6. Lysing is a term used to describe the detachment of bowel adhesions from the abdominal wall by cutting it with specialized surgical scissors.
Back to Reference
7. Dr. Gayle testified he left the trocar in place to allow Dr. Bozeman to remove it. Dr. Bozeman testified the trocar had already been removed when he arrived. This point is of no consequence to the disposition of this appeal.
Back to Reference
8. All medical experts and the medical review panel agreed that calling in a general surgeon for the purpose of repairing the bowel injury was within the applicable standard of care.
Back to Reference
9. Running the bowel is the inspection of the bowel by hand, moving it back and forth in one's hands, squeezing and applying pressure to check for leaks, bruises, cuts, and other damage.
Back to Reference
10. These factors explicitly included "fascial scarring or defects from prior surgery and differences in the degree of sharpness of disposable trocars." (Opinion of Medical Review Panel, p. 2)
Back to Reference
11. Members of the panel admitted to placing greater weight on Dr. Gayle's operative note than on his sworn deposition, in which he admitted to losing control "in a generic sense." (Deposition of Dr. Gayle, p. 67-68; Deposition of Dr. Hart, p. 18-19; Deposition of Dr. Carroll, p. 23)
Back to Reference
12. On October 23, 2007, Mrs. Patten amended her complaint and added Dr. Bozeman as a defendant. Dr. Bozeman filed peremptory exceptions of prescription and peremption, which were granted, and Dr. Bozeman was dismissed from the suit.
Back to Reference
13. Dr. Gayle has not contested this finding on appeal so we will not discuss the issue in depth.
Back to Reference
14. The bowel has multiple layers. A partial thickness injury is when some of the layers have been damaged. A partial thickness injury can later develop into a perforation due to pressure within the bowel.

http://www.leagle.com/xmlResult.aspx?page=2&xmldoc=In LACO 20110622396.xml&docbase=CSLWAR3-2007-CURR&SizeDisp=7

Amniotic membrane transplant a viable treatment option for restrictive strabismus

Amniotic membrane transplantation should be considered when treating difficult cases of restrictive strabismus because it helps prevent adhesion recurrence, a study found.

"Because amniotic membrane has anti-inflammatory and anti-fibrosis characteristics, it may reduce secondary scarring and help prevent recurrence of restrictive strabismus and the diplopia and pain that often accompany this type of strabismus," the authors said.

The retrospective, interventional case series included eight eyes of seven consecutive patients who had developed restrictive strabismus after periocular surgery due to conjunctival scarring, fat adherence syndrome or rectus muscle contracture.

After failed additional standard surgery to remove the adhesions, patients underwent amniotic membrane transplantation.

Six of seven patients experienced improved ocular motility, with no recurrent scarring. Their motility remained stable for the 5- to 13-month follow-up period, according to the study.

One patient had recurrent scarring with persistent diplopia.

http://www.osnsupersite.com/view.aspx?rid=85142

Saturday, June 25, 2011

Seprafilm death goes unreported to FDA

I am Mrs. Heisner's daughter. I realize that this is not the proper forum to discuss what happened to my mother and our family. A proper forum would be in a court of law, however, because we have been denied that forum, I would like to take this opportunity to tell my mother's story and, by doing so, illustrate just how confused our legal system has become.

My mother died after experiencing what we suspect was a massive reaction to Seprafilm. Seprafilm is a class 3 medical device. It is a bioresorbable membrane manufactured and sold by Genzyme to prevent adhesions following surgery. It is absorbed into the body several days after being placed. My mother didn't ask that Seprafilm be placed in her nor did our family. During routine gynecological surgery, it was discovered that she had adhesions in her small bowel area and so the surgeons “took care of it” while they had her in the operating room. After removing the adhesions, Seprafilm was placed on her small bowel to prevent the formation of further adhesions. It appeared that the surgery had gone well. After four days, she was sent home from the hospital. Within 24 hours, she was unable to keep down any food and became severely dehydrated. She was readmitted to the hospital a week after her surgery and, when the doctors re-opened her to discover what was going on, they found that her small bowel had entirely matted together. The doctor described it as looking and reacting like a bowl of left over spaghetti. We were also told that her intestines were “concrete” or, in other words, dead. The doctors had never seen this reaction and had no idea what to do. My mother spent three weeks in intensive care. Her system totally failed. Ultimately, we made the painful decision to remove her from life-support and she passed away.

I am describing this because we later learned that other people have reacted in a very similar way after receiving Seprafilm. Although most people didn't die as a result of their reaction, they did appear to be fine after Seprafilm was placed and then, within a few days, the reaction became apparent. We know this is the case because we have read adverse event reports on the FDA's MAUDE database that appear to mirror my mother's reaction. MAUDE, in fact, has 302 adverse event reports for Seprafilm, 14 of which are reports of deaths.

My mother's doctor reported her reaction while she was in intensive care. Genzyme provided their report to the FDA during that time, as well. They stated that the event type was “injury” and the patient outcome “required intervention”. There are no reports from Genzyme on the MAUDE database that state that my mother's outcome was death. I suspect that they reported to the FDA so quickly because they wanted to avoid having to file such a report.

My family decided to bring a lawsuit against Genzyme because we want them to figure out why people are reacting in this way after Seprafilm is used. We also want them to tell doctors about the possibility of this reaction and let them know what to do if it happens. We consider that to be Genzyme's responsibility, not ours. And yet, in order to be granted the privilege of standing before a judge and telling him or her our situation, we feel as though we have to tell the judge what exactly went wrong. We don't know why our mother reacted like she did, we only know that she reacted and died and there is no doubt in our minds that the reaction was caused by Seprafilm.

10:33 AM
Laura (cont) said...
So now, what seems like such a basic right, our right to a day in court, has been taken away from us because of what we consider “loopholes” that lawyers have discovered and made law. Even though we suspect that Genzyme has not reported properly to the FDA, because of Buckman, we can't claim it. Even though we suspect that Genzyme is not providing the warnings that they should on Seprafilm's labeling, because of Riegel, we can't claim it. We are left with absolutely no recourse. Jayne Heisner's life has been taken and the only thing that we can do is to let people know what happened on this blog.

Ultimately, I hope that someone from the FDA reads this and discovers why Genzyme has been allowed to sell a product that can possibly cause such catastrophic outcomes and not warn people of this possibility. I hope that someone from Congress reads this and decides that the Medical Device Safety Act needs to be passed quickly. I hope that someone from Genzyme reads this and decides that something should be done. If anyone from the FDA , Congress or Genzyme would like to contact me, my email is Lauras6320@yahoo.com. I would be happy discuss this with them and then, possibly something good will come from this horrible situation.

10:36 AM

ARTILCLE THIS COMMENT WAS FOUND WITH
Friday, March 12, 2010
Heisner - Strike 3
Like a bad penny, this Heisner v. Genzyme complaint keeps turning up, getting dismissed for lack of facts, and coming back again in yet another iteration. Now at the "third amended" stage, it's been dismissed again. See Heisner v. Genzyme Corp., No. 08-C-593, slip op. (N.D. Ill. March 8, 2010). As you'll see from our device preemption scorecard, previous versions were dismissed at Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008) (plaintiff didn't pleas any parallel claims), and Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009) (negligence per se claims weren't parallel). Heisner has now been around for some two years and the plaintiffs haven't mustered a decent complaint yet.

Strike three and you're out? Yes. This time the court dismissed the complaint with prejudice. Slip op. at 8.

Anyway, the latest decision, which we'll call "Heisner III," found essentially more of the same. Each time plaintiff gets told to go back to the drawing board, he comes back with more words and less (or at least no more) substance. There doesn't seem to be any way around preemption in this case, as much as plaintiff has tried. You can't have a "parallel" claim that isn't really parallel - or as the court puts it, "state and federal requirements are not equivalent if a manufacturer could be held liable under state law while complying with federal requirements." Slip op. at 5 (citation omitted).

This time the plaintiff tried to equate the FDA's CBE warning update regulations with a common law claim for post-sale duty to warn. But that didn't fare any better (even after plaintiff belated discovered that the CBE regulation for devices was different than the one for drugs), because the CBE regulation is voluntary, whereas the tort claim would make it mandatory. Slip op. at 5-6.

Everything else in the plaintiff's, longer complaint remained too vague and devoid of facts. "Plaintiff utilizes more words, but verbosity cannot substitute for factual allegations." Slip op. at 7.

A claimed failure to file adverse reaction reports didn't constitute a product defect. Slip op. at 6 ("failure to report adverse events to the FDA may violate the FDCA, but does not constitute a product “condition” or defect"). Negligence per se claims still couldn't possibly be causal, since they postdated the alleged injury. Id.

We thank another of our anonymous (by request) readers for passing Heisner III along.
http://druganddevicelaw.blogspot.com/2010/03/heisner-strike-3.html