By Daniel Kuy, MD, FACS
On Sept 8th, 2011 the Food and Drug Administration and the Medical Device Advisory Committee conducted a panel hearing over two days on silicone gel filled breast implants. Dr. William Maisel, chief scientist for the Food and Drug Administration Center for Devices said, “we believe the benefits and risks of the silicone implants are sufficiently well understood.” After two days of discussion testimony, the agency officials said silicone breast implants were safe and studies would continue.
Dr. Maisel said, “We felt before the meeting that silicone breast implants were safe and we continue to feel that way after the presentations and discussion over the past two days.” There are risks to the implants, however, Dr. Maisel said, including ruptures, a hardening of the area around the implant, the need to remove the implants, scarring, pain, infection, and asymmetry. “Women should feel assured that the FDA continues to believe that currently marketed silicone breast implants are safe and the current post approval studies will continue to better understand these potential risks.”
The committee also agreed that the patient should no longer be told that their breast need to be screened with an MRI three years after getting the implants or every two years following. Most patients have ignored the requirement because MRIs are expensive and it is still not clear what should be done when unforeseen ruptures are discovered. The risk associated with leaking implants may not be greater than the risk of the operation needed to take them out. The FDA continues to believe, as does the pane members that the MRI is the goal standard for evaluating breast implants for silent rupture.
US surgeons performed nearly 400,000 breast implant procedures last year, more than half the operations used silicone gel filled breast implants. Unfortunately, many study participants have been lost to follow up. One frequently mentioned reason for the low followup rates in the post market studies was that augmentation patients see no reason to return for checkups if they have no problems. Dr. Maisel said that the decision to keep the implants on the market is not just based on the companies’ market studies. The FDA has looked already that the studies conducted prior, which have longer and better followup than the ones launched after the approval of the silicone filled breast implants.
Towards the end of the final days of the hearings, the panel commented that they were impressed by the two plastic surgery societies, efforts to generate data and address important issues such as international registries, labeling compliance, patient confidentiality and informed consent.
Everybody seems committed to see the ongoing studies to be completed and also remain committed to see the follow up rates improved.
Friday, September 23, 2011
Tuesday, March 8, 2011
Dr. Mangat and Dr. Holzapfel attend surgical mission to Belize
Dr. Devinder Mangat and Dr. Allison Holzapfel recently returned from a week long surgical mission trip to Orange Walk, Belize. This area of Central America lacks sufficient surgical services in the fields of plastic surgery and otolaryngology-head and neck surgery. During their week in Belize, over 250 people showed up for the screening day and the surgeons performed over 100 surgeries!
In 2004, Horizon Community Church set up a mission trip and traveled there to help build houses, install screens and run a vacation Bible school. A small surgical team provided medical help. Since that trip, the team has grown to having more than 50 volunteers. Dr. Mangat joined the trip six years ago and recruited Dr. Holzapfel to join for the first time this year.
The trip is quite busy with all the physicians and support personnel working long hours. The most rewarding part is seeing the patients after surgery with huge smiles on their faces.
Monday, May 31, 2010
The Liquid Facelift
Over the years, the face begins to lose volume and elasticity leading to the formation of wrinkles, creases and folds. This loss of collagen and elastin contributes to sagging facial features causing many of us to think we need surgery. With the development of many of the new FDA-approved dermal fillers, Botox®, and Dysport®; physicians have been able to "lift" the face without having to resort to surgery.
Many of the techniques now used focus on lifting and contouring the face, with the added benefit of wrinkle reduction. This differing approach to the treatment of sagging facial features has been called a Liquid Face Lift, a non-surgical face lift alternative.
A Liquid Face Lift can accomplish any of the following:
- Gentle lift of individual or overall facial features
- Reduced wrinkles, creases or folds
- Restoration of natural, curved facial contours
- A more rested, energetic look
- A friendlier smile
For example, bags can be masked under the eyes by using Liquid Facelift techniques; eyes can be opened up and lids lifted; jowls can be lifted and diminished; natural shape can be restored to flattened cheeks or temple areas; corners of the mouth can be lifted; as well as several other facial feature benefits.
A Liquid Face Lift involves the use of dermal fillers in combination with Botox® or Dysport®. The fillers include Juvederm™ Ultra, Juvederm™ Ultra Plus, Radiesse®, Restylane® and Sculptra.
Not only is product choice important, but it is fundamental that the physician take into account a patient's unique facial characteristics and goals when performing a Liquid Face Lift procedure. Each person has unique facial features and individual skin types, as well as varying degrees of skin damage, collagen depletion and skin laxity. Goals and desires also vary from patient to patient.
Results from these procedures are usually gradual and can range from subtle to astonishing. It is common for patients who have had these procedures to say that they receive compliments on their appearance without others knowing that they have done anything. As with any cosmetic medical procedure, results vary from patient to patient.
Interested in trying a Liquid Face Lift? We're taking 20% OFF Juvederm™ Ultra, Juvederm™ Ultra Plus, Radiesse®, Restylane® and Sculptra® for our May special.
Find a coupon at http://www.renewyourlooks.com/asp/coupons.asp.
(expires June 30,2010)
Call and schedule your appointment today! 513-984-FACE (3223)
Tuesday, January 12, 2010
The Full Face Chemical Peel
THE PROCEDURE OF THE MONTH
Each month, we will feature one procedure performed at our center to educate our clients. The series will begin with the Chemical Peel.
Chemical peels come in many varieties. The light, or superficial, peels are performed by aestheticians or skin care specialists. The chemicals may include glycolic, salicylic, lactic or other fruit acids. These peels cause little or no downtime and are excellent for skin care maintenance and rejuvenation.
Medium depth chemical peels are usually performed by physicians. The peels used most often are the 30% to 35% TCA (trichloroacetic acid) peels and the straight 89% phenol peel. This peel is used to treat brown spots, uneven pigmentation, mild wrinkles and mild acne scars. Healing times is less than 7 days and mild redness fades in 4 to 6 weeks.
Each month, we will feature one procedure performed at our center to educate our clients. The series will begin with the Chemical Peel.
Chemical peels come in many varieties. The light, or superficial, peels are performed by aestheticians or skin care specialists. The chemicals may include glycolic, salicylic, lactic or other fruit acids. These peels cause little or no downtime and are excellent for skin care maintenance and rejuvenation.
Medium depth chemical peels are usually performed by physicians. The peels used most often are the 30% to 35% TCA (trichloroacetic acid) peels and the straight 89% phenol peel. This peel is used to treat brown spots, uneven pigmentation, mild wrinkles and mild acne scars. Healing times is less than 7 days and mild redness fades in 4 to 6 weeks.
The workhorse of skin resurfacing is the Deep chemical peel. We use the Hetter Peel for deep skin resurfacing. The solution is a unique combination of Phenol and Croton Oil that can be applied in different strengths based on the individual patient's skin type and amount of skin rejuvenation needed. The peel is used to treat patients who have coarse facial wrinkles, severe sun damage, or pre-cancerous growths on their face. The dramatic results from this type of peel produce smoother, tighter, younger-looking skin.
Make an appointment to see which peel is right for you and save $500 if you schedule your medium or deep chemical peel before 2-15-10.
Make an appointment to see which peel is right for you and save $500 if you schedule your medium or deep chemical peel before 2-15-10.
(859)331-9600
Monday, September 14, 2009
Plastic Surgery May Also Ease Migraines
MANY of the nearly 30 million Americans who suffer from migraines end up feeling like guinea pigs. Chronic patients — those who are laid low 15 or more days a month — often cycle through drug after drug in search of relief. They also contend with side effects like mental sluggishness and stomach upset. Treatment involves guesswork because doctors have not pinpointed what causes migraines, nor do they know which drugs will best help which patients.
“It can be a merry-go-round going from medication to medication in pursuit of control,” said Dr. Roger K. Cady, the vice president of the board for the National Headache Foundation, a nonprofit organization devoted to patient education.
No wonder that last month, news of a surgical “cure” that touts a high success rate ricocheted worldwide. The double-blind study, published in the journal Plastic and Reconstructive Surgery, found that more than 80 percent of patients who underwent surgery in one of three “trigger sites” significantly reduced their number of headaches compared with more than 55 percent of the group who had sham surgery. More than half of the patients with the real surgery reported a “complete elimination” of headaches compared with about 4 percent of the placebo group.
Forehead lifts are cosmetic procedures that plastic surgeons typically perform to smooth furrowed brows. But a decade ago, after some of his patients reported that their migraines improved post-operation, Dr. Bahman Guyuron, a plastic surgeon and the lead author of the study, began to search for a surgical solution that could address migraine trigger points — which he defines as where the headache begins and settles — in the forehead, temples and the back of the head
Headache specialists tend to be neurologists or internists, so Dr. Guyuron’s work has not always been taken seriously. “If I had a neurologist tell me there’s a new way of doing a facelift, I would have been very skeptical about it also,” said Dr. Guyuron, the chairman of the plastic surgery department at University Hospitals Case Medical Center in Cleveland. “But honestly I would have had an open mind.
”In the last month, the press has made much of the fact that a single operation could relieve migraines and turn back the clock in one fell swoop. But it is the potential that surgery for migraines may offer a viable alternative to drugs that has migraine specialists intrigued. “A very large subset became headache-free and remained headache-free for a year — that is a fantastic result,” said Dr. Richard B. Lipton, the director of the Montefiore Headache Center in the Bronx.
Especially considering that in the field of migraines, success is defined “as a reduction of 50 percent of attacks,” Dr. Cady said. Going from 10 episodes monthly to 5 is a welcome change, he added, but “it’s still a lot of migraines.”
The theory behind the surgery is that because some migraines are caused when sensitive nerve branches are squeezed and irritated by muscles, deactivating those muscles could bring prolonged relief. In the off-label use of Botox for migraines, those same muscles — when paralyzed with Botox injections — have eased headaches in some patients for roughly three months. Forehead lifts, Dr. Guyuron reasoned, might result in a longer-lasting, perhaps permanent, alleviation of pain. Only study participants who responded positively to Botox were offered the surgery.
(Dr. Cady cautioned that the research on Botox as a treatment for chronic headaches is not yet ironclad. Allergan, Botox’s maker, is pursuing the approval of Botox as a treatment for chronic migraines by the Food and Drug Administration.)
Many headache specialists, Dr. Lipton and Dr. Cady included, emphasize that this migraine surgery isn’t applicable to most sufferers. “Folks who are appropriate for this procedure — they are the tip of the iceberg, not the vast majority,” said Dr. Jennifer S. Kriegler, a neurologist who is one of the study’s authors and who works at the Cleveland Clinic’s headache center.
At this stage, suitable candidates are those who endure frequent migraines and have failed more tried-and-true methods of controlling their headaches, several doctors said. The bottom line, Dr. Lipton explained, is if you can’t identify a point of irritation and “if you don’t respond to Botox, we don’t know if this treatment works for you.
”Some doctors fear that the surgery may be offered to inappropriate patients before further research confirms its efficacy for a broader group of patients. “I don’t want us to overshoot and start doing widespread surgeries in not very well selected patients until we are convinced this is broadly effective,” said Dr. F. Michael Cutrer, the chief of the headache division in the neurology department at the Mayo Clinic in Rochester, Minn. “You can always stop a medication but you can’t reverse a surgery.”
As word of the surgery spreads, Dr. Cutrer said that he anticipated pleas for referrals to the few plastic surgeons nationwide who offer the operations, but that “until we maybe have studies that are a bit larger, and some longer follow-up I’m going to be very cautious.”
So far, Dr. Guyuron has trained roughly 150 doctors, and other plastic surgeons are refining their own migraine operations, even though they barely advertise.
Two years ago, an aunt told Shannon Byrne, from Mayfield Heights, Ohio, about Dr. Guyuron’s migraine surgery. Ms. Byrne said that she had already spent a decade on “every single medication you can think of.” Still, pain hammered her head more days than not. “You’re willing to try anything,” she said. Dr. Guyuron’s surgery, which she had 18 months ago, was a godsend. The migraines that led to her dropping out of college and to a stroke at 20 are gone. “My dad told me not to worry about the money,” Ms. Byrne, now 22, said of the thousands paid out of pocket.
A classic forehead lift for cosmetic effect differs significantly from surgery for migraine sufferers. The latter removes frown muscles more thoroughly and entails padding nerves with fatty tissue, said Dr. David A. Branch, a plastic surgeon in Bangor, Me., who performs migraine operations.
Sometimes, migraine surgery doesn’t involve the forehead at all. It varies according to where the patient’s trigger sites are: forehead, temples or back of the head. If Dr. Guyuron operates on the temples, the eyebrows are rejuvenated, he said. It is only the surgery at the back of the head that has no added perk, he said.
It’s unclear whether or not the migraine sufferers whose pain had disappeared a year post-operation will remain headache-free for life.
“My goal is zero headaches,” said Dr. Jeffrey E. Janis, a plastic surgeon in Dallas, who has performed roughly 100 operations in the last five years after training with Dr. Guyuron. “I might be able to achieve that in some, not in all.”
Complete elimination is “a pretty strong claim after one year of follow-up,” Dr. Cutrer said.
As a way of dampening expectations, Dr. Kriegler, who has referred patients to Dr. Guyuron, frequently tells them: “Once a migraineur, always a migraineur.”
“It can be a merry-go-round going from medication to medication in pursuit of control,” said Dr. Roger K. Cady, the vice president of the board for the National Headache Foundation, a nonprofit organization devoted to patient education.
No wonder that last month, news of a surgical “cure” that touts a high success rate ricocheted worldwide. The double-blind study, published in the journal Plastic and Reconstructive Surgery, found that more than 80 percent of patients who underwent surgery in one of three “trigger sites” significantly reduced their number of headaches compared with more than 55 percent of the group who had sham surgery. More than half of the patients with the real surgery reported a “complete elimination” of headaches compared with about 4 percent of the placebo group.
Forehead lifts are cosmetic procedures that plastic surgeons typically perform to smooth furrowed brows. But a decade ago, after some of his patients reported that their migraines improved post-operation, Dr. Bahman Guyuron, a plastic surgeon and the lead author of the study, began to search for a surgical solution that could address migraine trigger points — which he defines as where the headache begins and settles — in the forehead, temples and the back of the head
Headache specialists tend to be neurologists or internists, so Dr. Guyuron’s work has not always been taken seriously. “If I had a neurologist tell me there’s a new way of doing a facelift, I would have been very skeptical about it also,” said Dr. Guyuron, the chairman of the plastic surgery department at University Hospitals Case Medical Center in Cleveland. “But honestly I would have had an open mind.
”In the last month, the press has made much of the fact that a single operation could relieve migraines and turn back the clock in one fell swoop. But it is the potential that surgery for migraines may offer a viable alternative to drugs that has migraine specialists intrigued. “A very large subset became headache-free and remained headache-free for a year — that is a fantastic result,” said Dr. Richard B. Lipton, the director of the Montefiore Headache Center in the Bronx.
Especially considering that in the field of migraines, success is defined “as a reduction of 50 percent of attacks,” Dr. Cady said. Going from 10 episodes monthly to 5 is a welcome change, he added, but “it’s still a lot of migraines.”
The theory behind the surgery is that because some migraines are caused when sensitive nerve branches are squeezed and irritated by muscles, deactivating those muscles could bring prolonged relief. In the off-label use of Botox for migraines, those same muscles — when paralyzed with Botox injections — have eased headaches in some patients for roughly three months. Forehead lifts, Dr. Guyuron reasoned, might result in a longer-lasting, perhaps permanent, alleviation of pain. Only study participants who responded positively to Botox were offered the surgery.
(Dr. Cady cautioned that the research on Botox as a treatment for chronic headaches is not yet ironclad. Allergan, Botox’s maker, is pursuing the approval of Botox as a treatment for chronic migraines by the Food and Drug Administration.)
Many headache specialists, Dr. Lipton and Dr. Cady included, emphasize that this migraine surgery isn’t applicable to most sufferers. “Folks who are appropriate for this procedure — they are the tip of the iceberg, not the vast majority,” said Dr. Jennifer S. Kriegler, a neurologist who is one of the study’s authors and who works at the Cleveland Clinic’s headache center.
At this stage, suitable candidates are those who endure frequent migraines and have failed more tried-and-true methods of controlling their headaches, several doctors said. The bottom line, Dr. Lipton explained, is if you can’t identify a point of irritation and “if you don’t respond to Botox, we don’t know if this treatment works for you.
”Some doctors fear that the surgery may be offered to inappropriate patients before further research confirms its efficacy for a broader group of patients. “I don’t want us to overshoot and start doing widespread surgeries in not very well selected patients until we are convinced this is broadly effective,” said Dr. F. Michael Cutrer, the chief of the headache division in the neurology department at the Mayo Clinic in Rochester, Minn. “You can always stop a medication but you can’t reverse a surgery.”
As word of the surgery spreads, Dr. Cutrer said that he anticipated pleas for referrals to the few plastic surgeons nationwide who offer the operations, but that “until we maybe have studies that are a bit larger, and some longer follow-up I’m going to be very cautious.”
So far, Dr. Guyuron has trained roughly 150 doctors, and other plastic surgeons are refining their own migraine operations, even though they barely advertise.
Two years ago, an aunt told Shannon Byrne, from Mayfield Heights, Ohio, about Dr. Guyuron’s migraine surgery. Ms. Byrne said that she had already spent a decade on “every single medication you can think of.” Still, pain hammered her head more days than not. “You’re willing to try anything,” she said. Dr. Guyuron’s surgery, which she had 18 months ago, was a godsend. The migraines that led to her dropping out of college and to a stroke at 20 are gone. “My dad told me not to worry about the money,” Ms. Byrne, now 22, said of the thousands paid out of pocket.
A classic forehead lift for cosmetic effect differs significantly from surgery for migraine sufferers. The latter removes frown muscles more thoroughly and entails padding nerves with fatty tissue, said Dr. David A. Branch, a plastic surgeon in Bangor, Me., who performs migraine operations.
Sometimes, migraine surgery doesn’t involve the forehead at all. It varies according to where the patient’s trigger sites are: forehead, temples or back of the head. If Dr. Guyuron operates on the temples, the eyebrows are rejuvenated, he said. It is only the surgery at the back of the head that has no added perk, he said.
It’s unclear whether or not the migraine sufferers whose pain had disappeared a year post-operation will remain headache-free for life.
“My goal is zero headaches,” said Dr. Jeffrey E. Janis, a plastic surgeon in Dallas, who has performed roughly 100 operations in the last five years after training with Dr. Guyuron. “I might be able to achieve that in some, not in all.”
Complete elimination is “a pretty strong claim after one year of follow-up,” Dr. Cutrer said.
As a way of dampening expectations, Dr. Kriegler, who has referred patients to Dr. Guyuron, frequently tells them: “Once a migraineur, always a migraineur.”
Wednesday, September 2, 2009
The Importance of Nutrition & Surgery
Surgical outcome tends to improve when the patient is in good physical health. Optimizing a patient’s nutritional status is an important part of this process and is essential for proper wound healing.
Wound healing sets off a complex chain of events that involved increased cellular activity and an intensified metabolic demand for nutrients. This activity requires a number of vitamins and other chemical cofactors to complete its job. Without these building blocks, wound healing takes longer and may be compromised. Patients who don’t meet their nutritional needs may be at risk for increased bruising and swelling, delayed wound healing, and other wound-related complications.
To augment their health, many Americans are taking nutritional supplements on a routine basis. While generally beneficial and safe, the uses of several popular supplements, around the time of surgery, are not recommended. Certain nutritional supplements may cause adverse reactions during or after surgery, including prolonged bleeding.
We offer our surgery patients a line of vitamins and healing supplements that are formulated with essential nutrients to support wound healing, enhance tissue repair, support the immune system, prevent infection, minimize inflammation and reduce bruising. At the same time, the products have selectively excluded any nutrients that can cause problems during peri-operative period.
Wound healing sets off a complex chain of events that involved increased cellular activity and an intensified metabolic demand for nutrients. This activity requires a number of vitamins and other chemical cofactors to complete its job. Without these building blocks, wound healing takes longer and may be compromised. Patients who don’t meet their nutritional needs may be at risk for increased bruising and swelling, delayed wound healing, and other wound-related complications.
To augment their health, many Americans are taking nutritional supplements on a routine basis. While generally beneficial and safe, the uses of several popular supplements, around the time of surgery, are not recommended. Certain nutritional supplements may cause adverse reactions during or after surgery, including prolonged bleeding.
We offer our surgery patients a line of vitamins and healing supplements that are formulated with essential nutrients to support wound healing, enhance tissue repair, support the immune system, prevent infection, minimize inflammation and reduce bruising. At the same time, the products have selectively excluded any nutrients that can cause problems during peri-operative period.
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