On May 8, 2013, Intuitive Surgical, the manufacturer of the da Vinci surgical robot, issued an urgent medical device notification and also advised the Food and Drug Administration (FDA) of a problem with one of the surgical robot’s instruments.*
The document issued by the company warned that the Hot Shears™ Monopolar Curved Scissors may develop “micro-cracks,” which “may create a pathway for electrosurgical energy to leak to tissue during use.”* This leaked energy could potentially burn patients undergoing surgery.* Intuitive Surgical stressed, in bold print, that the micro-cracks in the scissors may not be visible to the user.*
The warning, which comes in the wake of several other da Vinci lawsuits, is of particular concern because of the wide range of procedures in which the scissors are used. The Hot Shears™ have been used to cut and coagulate tissue in common surgeries ranging from hysterectomies and prostatectomies to gastric bypass procedures.** There are at least 2,000 da Vinci robots in hospitals across the United States.**
The issue is currently under review at the Food and Drug Administration.** According to one FDA database, surgeons’ reports of accidental burns, punctures, and other “mishaps” (sometimes involving death) associated with the da Vinci system increased 34% between 2011 and 2012.** Because of the surprising number of reported adverse events, the FDA has been polling surgeons about their experience with the robot.
Despite reporting the issue to the FDA and issuing an urgent warning, Intuitive Surgical has attempted to downplay the problem. The company maintains that it has “no confirmed evidence of patient injury attributable to this issue.”** While denying that there was any energy leakage, the company does acknowledge that there was at least one instance in which a patient complained of injury following surgery with an instrument later found to contain micro-cracks.**
Even with a history of lawsuits, Intuitive Surgical has decided not to recall the surgical scissors. Instead, it has simply advised doctors that replacement shears will be available in two to four weeks.** Only time will tell whether further injuries caused by the Hot Shears™ will come to light. In the meantime, the surgical shears are still being used by healthcare facilities across the nation.
* May 8th Urgent Medical Device Notification by Intuitive Surgical, http://fm.cnbc.com/applications/cnbc.com/resources/editorialfiles/2013/05/10/UrgentDaVinci.pdf
** Crack-Prone Scissors May Burn Patients, Da Vinci Maker Says. Medscape. May 13, 2013, http://www.medscape.com/viewarticle/804067
Depakote (divalproex sodium), a valproate product1 and Topamax (topiramate)2 are prescription drugs primarily prescribed for treating seizures, although both drugs are also used to treat migraine headaches, and Depakote is also used to treat bipolar disorder.
Various worldwide studies have been conducted regarding the risk of birth defects associated with the use of these medications by women during pregnancy. The North American AED Pregnancy Registry was established in 1996 to study these risks, specifically focusing on Depakote and other valproate products. The study found that of the 149 women studied between 1997 and 2003, 16 of the infants born suffered from major birth defects.3 These birth defects include neural tube defects such as spina bifida.
A study conducted by the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) followed more than 300 children born to women being treated with a valproate product for epilepsy between 1999 and 2004. This particular study included 25 clinics in the U.S. and the U.K. Researchers found that “Three-year-olds whose mothers took the antiepileptic drug valproate during pregnancy had average IQs six to nine points lower than children exposed to three other antiepileptic drugs.”4
Valproate has also been linked to an increased risk of autism in an ongoing study lead by Gus Baker, PhD, FBPsS, of the University of Liverpool in the U.K., “The potential risk for autism in this study was substantial for children whose mothers took valproate while pregnant…”5
The Royal Group of Hospitals in Belfast, Northern Ireland performed a study which found that of 203 births to women who took Topamax during pregnancy, 16 had major birth defects. The study further found that the risk of cleft palate is 11 times higher, cleft lip 11 times higher and genital defects 14 times higher in women taking Topamax during pregnancy.8
In 2011, the FDA issued a warning that taking Topamax during pregnancy increases the risk of oral cleft birth defects6. A similar warning was issued for Depakote and other valproate products in 2009 with regards to the increased risk of neural tube defects and adverse effects in cognitive development.7
More recently, a study was conducted in Australia at the Royal Melbourne Hospital and University of Melbourne Australia to investigate the link between birth defects and the use of Depakote and Topamax. “The study revealed a statistically significant link between Topamax use during pregnancy and increased risks for giving birth to a baby born with hypospadias and so-called brain “maldevelopments.” (Hypospadias is when the urethra’s opening is formed on the underside of an infant’s penis).9
While the FDA did issue warnings in 2009 and 2011 respectively, these warnings came too late for women whose children have suffered birth defects related to their use of these medications during pregnancy, as the manufacturers did not provide a warning or information about these risks. As a result, lawsuits are being filed against the manufacturers, Abbot Laboratories and Janssen Pharmaceuticals, to hold them accountable for the harm their products caused.
If you or someone you know has suffered a birth defect that may be related to Topamax or Depakote, please contact Audet & Partners, LLP by calling us toll free at 800.965.1461, or complete and submit our confidential inquiry form on the right side of this page. Please act now, since the law may limit your right to recovery if you delay.
One of the most serious complications associated with the Mirena IUD is perforation of the uterus or migration of the IUD within the body. These complications may cause further problems that include but are not limited to: injury or perforation of other organs, infection, adhesions, infertility, and/or ectopic pregnancy.
Symptoms[i] of uterine perforation and/or migration include: lower abdominal pain, severe cramping, bleeding, nausea, vomiting, and/or fever. “A ‘missing’ IUD string should raise suspicion”[ii] of IUDs that may have perforated the uterine wall or migrated within the body
Oftentimes, the symptoms are mistaken for other health concerns, as was the case with a woman who was treated for non-existent ovarian cysts. She posted her experience on the CureZone.org[ii]. After two years, many visits to several doctors, x-rays, ultrasounds, a CAT Scan finally enabled doctors to see that the Mirena IUD had punctured this woman’s uterus in two places, requiring surgery for its removal. She continued to experience issues relating to remaining scar tissue in her uterus.
In other cases, upon being unable to locate the IUD, doctors have indicated to patients that the IUD must have been expelled. Seven weeks after delivery, a 31-year-old woman underwent insertion of an IUD. One year later, the doctor was unable to find the IUD upon physical examination, ultrasound and x-ray. It was therefore assumed that it had been expelled. Later that year, upon x-ray of the lumbar spine, the IUD was located and surgically removed.[iii]
Melody Williams of California experienced abdominal cramping and when doctors attempted to remove the IUD, they discovered that it had migrated through her fallopian tube, resulting in infection.[iv]
According to a study conducted by ehealthme.com[v], as of March 20, 2013, of 58,328 women who reported experiencing negative side-effects related to the Mirena IUD, 1,394 indicated that their IUD had migrated from their uterus to other locations in their bodies. WebMD.com indicates that perforation will occur in 1 out of 1,000 women. Considering that over two million women have been implanted with the Mirena IUD[vi], these odds are extremely alarming.
In an effort to warn and educate other women about these issues, those who have experienced uterine perforation or migration of the Mirena IUD have created numerous blogs to share their experiences. Below are a few samples of what is being said by these women who have been negatively affected:
If you used the Mirena IUD and have experienced serious complications, our experienced product liability attorneys at Audet and Partners, LLP offer a free consultation so that we can evaluate your legal claim and advise you of your options. We invite you to call us at (800) 965-1461 or fill out the confidential case inquiry form on the right side of this page.
Pelvic Organ Prolapse (“POP”), aka bladder prolapse, and Stress Urinary Incontinence (“SUI”) are common conditions in women. The University of Rochester Medical Center conducted a study[i] of 16,616 women with a uterus and found that 41% have experienced POP. SUI’s prevalence is said to occur in 30% of women five years after a vaginal delivery[ii], but due to its seemingly embarrassing nature, SUI is underreported and many who suffer from it do not seek treatment. Dr. Memel Harrison conducted a study[iii] through a questionnaire, which found that 46% of the 314 women (between the ages of 20-80) that responded correctly to the questionnaire had SUI.
POP is when supportive tissues in the pelvic region become weak and because of the arrangement and location of the uterus, bladder and rectum, they can herniate or bulge into the vaginal canal.[iv] SUI is the unintentional loss of urine due to physical movement or activity (i.e. coughing, sneezing, lifting, etc.[v]) POP and SUI[vi] are commonly caused by pregnancy and childbirth, menopause (decrease in estrogen levels can lead to weak pelvic muscles), age, and obesity.
Surgical mesh, originally developed in the 1950s for the treatment of hernias, became a popular treatment for POP and SUI in the ‘90s, known as transvaginal mesh. It is a type of sling that is positioned to provide support for the affected organ(s) relating to POP, or under the urethra and bladder relating to SUI[vii]. The FDA fast-tracked its approval process to allow manufacturers to begin selling it prior to a full FDA review, which can be lengthy and costly.
Serious complications have been reported after implantation of the device, including:
- Vaginal mesh erosion
- Pain (including during intercourse)
- Urinary problems
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
- Organ perforation
The FDA conducted a search of adverse event reports received between January 1, 2005 – December 31, 2010, which were directly associated with the transvaginal mesh implants; this search which identified 3,979 reports of injury, death and malfunction.[viii] As a result, the FDA issued an update stating that “…serious complications associated with surgical mesh for transvaginal repair of POP are not rare…furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”viii
In July 2011, the FDA warned that there was a five-fold increase of injury relating to insertion and use of the transvaginal mesh.[ix] According to an article published by the New York Times in January 2012, 185,000 women underwent the procedure for implantation of the transvaginal mesh in 2010 alone. That same year, 15% of those women experienced potential complications.[x] Frequently, surgical revision or removal of the transvaginal mesh is necessary, which can be painful, costly, and dangerous.
Over objections raised by Bayer Healthcare Pharmaceuticals*, the United States Judicial Panel (“USJP”) on Multidistrict Litigation has consolidated most federal lawsuits alleging injuries caused by the Mirena intrauterine device. In the matter of In Re: Mirena IUD Products Liability Litigation, MDL No. 2434, the Panel ruled that cases alleging the migration and/or perforation of the device, and the inadequacy of the warnings issued by Bayer with regard to these risks, will now be heard in the United States District Court for the Southern District of New York.
In the Order signed by Acting Chairman Kathryn H. Vratil, the USJP noted that:
“Transfer under [28 U.S.C.] Section 1407 will offer the benefit of placing all related actions before a single judge who can structure pretrial proceedings to accommodate all parties’ legitimate discovery needs while ensuring that common witnesses are not subjected to duplicative discovery demands.”
In a hearing last month in San Diego, attorneys representing women alleging injuries caused by the Mirena IUD, including William M. Audet of Audet and Partners, LLP in San Francisco, CA, argued that the number of claims now being filed was of a size that clearly warranted consolidation.* The USJP apparently agreed in its Order, ruling that transfer of the Mirena lawsuits “promotes the just and efficient conduct of this litigation.”
“In consolidating the large number of Mirena lawsuits spread throughout the United States, the USJP is ensuring the efficient administration of justice for women who have suffered serious injuries allegedly caused by the Mirena IUD ranging from dangerous abscesses to infertility,” explains William Audet. “We look forward to seeing that these claims are properly addressed in the multidistrict litigation established by today’s Order.”
The Mirena IUD, manufactured by Bayer, was approved by the FDA in 2000 as a contraceptive device recommended to women who have had at least one child. This small, t-shaped plastic device is inserted by a health care professional and can be left in place for up to five years.**
Among its marketing strategies for the Mirena IUD, Bayer held “Mirena Parties” for “busy moms” in connection with the social networking site Mom Central. At these gatherings, a representative from Mom Central was joined by a nurse practitioner. The orchestrated presentation included a marketing script touting the ability of Mirena to help women “look and feel great” and heighten sexual intimacy with their partners.**
If you, or one close to you, may have suffered serious side effects as a result of use of the Mirena IUD, you can request a free case review by calling Audet and Partners, LLP at (800) 965-1461, or by visiting http://www.mirenacomplaints.com online.
Jury selection has begun in a multi-district litigation case against Takeda, the manufacturer of Actos, a drug used in the treatment of diabetes II to increase the body’s sensitivity to insulin. The lawsuit is the direct result of numerous negative side effects associated with the use of Actos, in particular:
• congestive heart failure
• liver damage
• kidney damage
• bone fractures
• bladder cancer
Bladder cancer is possibly the most prominent side effect that has been directly linked to long-term use (typically more than one year) of Actos.
As litigation proceeds, additional evidence is coming forth that demonstrates Takeda’s inadequate attitude toward the safety and health of Actos users. Recently, the first witness in the case was called to testify. On March 5th, Howard Greenberg, a clinical pharmacologist, testified that, “There are multiple emails from different levels of Takeda management that indicate the product came first.”
One of the emails Greenberg refers to came from Kiyoshi Kitazawa, a Takeda executive. In 2005 he wrote, “Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally.” According to Kitazawa, the “worst case scenario” would be that regulators require warning labels of bladder cancer.
In 2011, after analysis of a company-sponsored study showing an increased risk of bladder cancer in Actos users, the FDA required that a warning label be listed on the product; however, for those who had used it prior to that time, it was too late. At this same time, Actos was pulled from the market in France and Germany.
Clearly, Takeda’s dependence on the sales and success of Actos clouded their ethical duty to clearly warn users of its potential dangers. They were more concerned about the global “damage” to their product than the potential injuries that users might suffer.
Many patients who have suffered injuries from their use of Actos have stated that they would have sought an alternative treatment had they known about the potential hazards. One plaintiff, a 57-year-old warehouse worker from New York stated, “If somebody had told me that I could get cancer from Actos, I never would have taken it.”
Interestingly, Takeda’s website states that they are, “…an organization based on integrity.” In addition, the website also states the following:
“To ensure that patients and consumers receive high quality pharmaceutical products, it is essential to rigorously manage quality control across the entire supply chain. To help with this, Takeda has been creating a centrally managed database of various quality-related data and the latest evaluation results of suppliers around the world, including those of the legacy Nycomed. If problems arise in future, this database will enable us to deal with them swiftly.”
With the increasing number of individuals coming forward with injuries related to their use of Actos, Takeda will have to answer for their actions of putting the product before the health and saftey of consumers, and lack of regard for the risks connected to use of Actos.
Intuitive Surgical Inc. is confronting new allegations that it failed to provide adequate training for physicians using its da Vinci surgical robot, and may have encouraged less training, thereby increasing the risks to patients undergoing robotic surgery.
No strict training guidelines or requirements currently exist that govern a physician use of the robot on a live patient. The amount and depth of training is currently left within the purview of individual doctors and/or hospitals. Undisclosed personnel from Wentworth-Douglass Hospital in Dover, NH, have stated that their training included only two days of operation on a pig and human cadavers.
Intuitive’s chief medical advisor, Myriam Curet stated that, “The training we do is quite extensive,” and according to Intuitive’s website, “We believe rigorous training standards and support of our System users are essential to establishing and maintaining a successful da Vinci Surgery program.” However, Intuitive’s suggested training regimen hardly seems adequate as it only includes an online quiz consisting of 10 hard-to-fail questions, practice simulators and a one-day training course, as well as a minimal number of proctored cases.
Interestingly, prior to the robot being cleared by the FDA in 2009, the online quiz was 70 questions and the training course was three days long. With regards to adequate training, Benjamin O. Anderson, an FDA panel member at the time, stated that it “is the most important part of what was discussed today.”
In response to a recent lawsuit, Intuitive argued that because “credentialing and privileging for performing surgery at a hospital is solely the responsibility of the hospital,” the case should be dismissed. This particular case was subsequently settled. Nonetheless, lawsuits are continuing to be filed in connection with injuries sustained by patients alleging as causative factors inadequately trained doctors using the robot.
Internal Intuitive emails introduced in a lawsuit filed in Kitsap County, Washington have uncovered a manager’s recommendation to a sales team in connection with meeting sales goals, to not “let proctoring or credentialing get in the way.”
Doctors themselves are voicing their opinions about the learning curve of the robot:
- The American Association of Gynecologic Laparoscopists suggests at least 10 supervised surgeries prior to allowing doctors to use the robot unsupervised.
- Dr. Jim Hu, director of Urologic Robotic and Minimally Invasive Surgery at the David Geffen School of Medicine at the University of California, Los Angeles indicates that, “The robot surgery requires a long learning curve to become good at it,” and specifically referring to prostate cancer surgery, Hu says that proficiency can take up to 200 plus operations to achieve. Dr. Hu assisted on 400 robot surgeries prior to performing them on his own. “None of us would go and get surgery if we knew the guy had done it just a couple of time before,” he says.
- According to a recent study conducted by the Mayo Clinic, published in the Obstetrics & Gynecology medical journal, surgical proficiency “occurs after performing approximately 91 procedures.”
Dr. Anne Kalter, a surgeon from Wentworth-Douglass Hospital, a supporter of robotic surgery, has said that in connection with adequate training, “There is no national standard requirement for this…it will probably be coming in the next couple of years. The technology is so new that every hospital has been finding out on its own what path is comfortable for them to take. “ Unfortunately, the path Wentworth-Douglass chose to take obviously was not adequate. During two routine hysterectomies, a physician accidentally cut the ureters of the patients. Subsequently, the physician performing the surgery and the supervising physician were both required to have remedial training.
Related to lawsuits filed against Fresenius Medical Care in connection with its dialysis products GranuFlo and NaturaLyte, lawsuits are now being filed against the dialysis treatment center, Da Vita Healthcare, in connection with their administration of GranuFlo and NaturaLyte.
GranuFlo and NaturaLyte are drugs used in hemodialysis to treat patients suffering from kidney disease and/or failure. The products were recalled by the FDA in March 2012 mandating revisisons to prescribing instructions to include the health risks connected with the use of these drugs. This was due to an investigation conducted by the FDA with results indicating that use of GranuFlo and NaturaLyte can lead to a heart attack. This risk is due to an ingredient in the drugs that can lead to metabolic alkalosis, which produces high levels of bicarbonate, increasing the risk of heart attack.
The FDA recall was worded as follows:
“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.”
As previously reported by Audet and Partners, LLP, the lawsuit filed against Fresenius Medical Care alleges that prior to the FDA’s recall, Fresenius was aware of the potential risks and failed to inform patients and healthcare providers. “Plaintiffs allege that the manufacturer intentionally, recklessly and/or negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte.”
Recent lawsuits filed against DaVita allege that it acted negligently through its alleged knowledge that high levels of bicarbonate can cause heart attack, and that the necessary amount of patient supervision, action to eliminate this risk, and/or appropriate treatment during GranuFlo and/or NaturaLyte administration were not provided.
Johnny Williams of Alabama was treated with these drugs at a DaVita dialysis center in June 2010; one month after treatment began, Johnny suffered a heart attack and died. His wife, Arthurine Williams, as administrator of Johnny’s estate, subsequently filed a lawsuit against Fresenius.
According to DaVita, “As of December 31, 2012, DaVita operated or provided administrative services at 1,954 outpatient dialysis centers located in the United States serving approximately 153,000 patients. The company also operated 36 outpatient dialysis centers located in five countries outside the United States.”
While a decision on Bayer’s Motion opposing the consolidation of federal Mirena lawsuits is yet to be issued, more women are surfacing to share their experiences related to implantation and the subsequent side effects of the Mirena IUD. Consequently, more lawsuits are being filed.
Regardless of the decision to be issued by the court in connection with Bayer’s opposition to federal case consolidation, Bayer will have to account for the allegations being made against them, and the numerous cases of damages suffered by their users.
Entire websites and blogs are being created by victims, detailing their horrific experiences with this particular IUD. Many of the victims have said that they were under-informed about the side effects, which have caused them extreme hardship and in some cases, irreparable damage. These include:
- Migraine headaches
- Weight gain
- Decreased libido
- Extreme fatigue
- Abdominal cramping
One of the Plaintiffs, a Missouri woman, experienced no side effects after the initial implantation; however, approximately one year later, she began experiencing severe cramping. A visit to the ER and an ultrasound revealed that the Mirena IUD had perforated her uterine wall, leading to surgery for its removal. Bayer’s caution in this regard was only in reference to perforation during implantation, not after.
Another startling situation involved a young woman whose Mirena IUD had migrated within her body. Her health care providers were unable to locate the IUD after its migration, and assumed that it had fallen out. Unfortunately, it had not fallen out but remained in her body for years. It was not located until she began experiencing abdominal cramping when she was 12 weeks pregnant, which required a very high risk surgery to remove the IUD.
Infertility as a result of uterine perforation is a possibility. One woman became pregnant shortly after she underwent surgery to remove a Mirena IUD that had perforated her uterine wall. She subsequently suffered a miscarriage and now may be infertile.
As with many pharmaceutical companies, Bayer invested millions in their marketing campaign, targeting “busy moms” who already had children and were looking for a long-term, effective and convenient form of birth control that had the ability to increase a woman’s libido. This campaign was hugely successful. The use of IUDs as an effective means of birth control increased 10.4 percent. Bayer clearly over-promised and under-delivered.
The pending lawsuits allege that Bayer misrepresented the benefits of Mirena, failed to warn about dangerous side effects, understated the product’s complications as “uncommon,” engaged in deceptive marketing, breached implied and express warranty, concealed the harmful side effects of Mirena, failed to provide adequate warnings and instructions, produced and knowingly sold and distributed a defective product, and designed a defective product.
Robotic hysterectomy for surgery has become more common over the past three years; however, experts are saying that it is more appropriately suited for complex conditions. Dr. James Breeden, president of The American College of Obstetrics and Gynecologists (ACOG) released a statement reflecting the ACOG’s opinion about robotic surgery for hysterectomy:
“While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes. Consequently, there is no good data proving that robotic hysterectomy is even as good as – let alone better – than existing, and far less costly, minimally invasive alternatives.”
A considerable amount of money has been spent on the marketing and advertising of this device by its manufacturers, and it appears to be effective. According to a recent study, over the past three years, the number of robotic hysterectomies has increased approximately 10 percent. Dr. Breeden boldly states that, “It is important to separate the marketing hype from reality when considering the best surgical approach for hysterectomy.”
Dr. Joel Weissman from Brigham and Women’s Hospital in Boston appears to agree with Dr. Breeden when he stated, “This is clearly in some ways a waste of resources…it’s a waste because there are equally good options and one is just more expensive than the other.”
Research conducted and led by Dr. Jason Wright from Columbia University in New York found a very minimal advantage of robotic surgery versus non-robotic: instead of the standard 25 percent of women staying longer than two days after non-robotic surgery, only 20 percent stayed longer than two days after the robotic surgery. In addition, they found no difference in a woman’s chances of requiring a blood transfusion or specialty care, based on the type of procedure (i.e. robotic or non-robotic surgery).
Second to cesarean sections, hysterectomies are the most common surgical procedure performed on women. It’s obvious why manufacturers of the robotic device are pushing its use beyond complex hysterectomies.
According to Dr. Breeden, “…an estimated $960 million to $1.9 billion will be added to the health care system if robotic surgery is used for all hysterectomies each year.” Dr. Wright and his team found that the average cost for a robotic-assisted hysterectomy was approximately $8,900, while non-robotic surgery costs approximately $6,700.
Any patient considering a hysterectomy should consult with their doctor regarding the various procedures available, their benefits and risks. Any procedure of this type has associated risks, such as reaction to anesthesia, bleeding, infection, damage to other organs inside the abdomen, blood clots, etc. However, patients should be aware of a risk specifically associated with use of the robotic device: robotic surgeries generally take longer, meaning that the patient is under anesthesia longer, increasing other risks.
The use of an expensive robot that does not have any proven benefits for standard hysterectomies appears to simply be a money-making scheme and patients should fully investigate their options prior to surgery.