Dr. Larry Nichter of the Pacific Center for Plastic Surgery would like to make prospective breast augmentation patients aware that the FDA has approved a new silicone gel-filled breast implant made by Sientra, Inc. for use in the United States.
The implants will be available for women at least 22 years old seeking augmentation surgery, and women of any age seeking breast reconstruction surgery.
Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.
This approval introduces a third company into the U.S. breast implant market, which previously consisted only of Allergan and Mentor.
The deputy director for for science at the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, commented that although silicone gel-filled breast implants have demonstrated consistent safety, “It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”
The approval of these new implants follows a 3-year study involving clinical trials of the implants on 1,788 women.
As a condition of the approval, Sientra will carry out five- and ten-year studies into the long-term health effects of their implants.
Source: FDA – FDA approves new silicone gel-filled breast implant
Dr. Larry Nichter of the Pacific Center for plastic surgery would like to make prospective patients aware of the risks and downsides of medical tourism (traveling abroad to undergo elective surgery).
Medical tourism has becoming increasingly popular in recent years; patients have been flying out of the U.S. for plastic surgery, lured by lower prices.
However, a parallel trend has also appeared: plastic surgeons in the United States are finding themselves treating an increasing number of patients who plastic surgery abroad, correcting complications and errors. A survey by the American Society of Plastic Surgeons found that 80% of the responding doctors had treated American medical tourists for complications including infection, contour abnormalities, and hematoma.
Medical tourists are often led to believe that they will receive the same quality of care for a lower price in a foreign clinic. But while it is true that the cost of plastic surgery in some foreign countries is lower, this is often because the quality of care and surgery is compromised. Such patients also seem to neglect the possibility of complications and the need for a follow-up visit.
In addition to the risks posed by sub-standard medical care abroad, medical tourists must consider the risks of injections and implants in other countries. The recent crisis with French breast implant maker Poly Implant Prothese (PIP) exemplifies this problem. PIP used industrial- rather than medical-grade silicone on their implants in an effort to reduce costs, a measure which probably increased the danger of rupture. PIP implants have not been used in the United States since 2000. Removal of these implants has been recommended by the International Society of Aesthetic Plastic Surgery.
It is often the case that medical tourists end up spending more money because they have to pay to treat complications from their overseas surgery.
Source: The Cost of Medical Tourism – Medscape Medical News
Source: Official Statement on Faulty PIP and ROFIL breast implants – ISAPS
Dr. Larry Nichter of the Pacific Center for Plastic Surgery would like to inform prospective patients about the rising concern of Body Dysmorphic Disorder as it relates to plastic surgery.
An article from the Mayo Clinic on Body Dysmorphic Disorder describes the disorder:
Body dysmorphic disorder is a type of chronic mental illness in which you can’t stop thinking about a flaw with your appearance — a flaw that is either minor or imagined. But to you, your appearance seems so shameful that you don’t want to be seen by anyone. Body dysmorphic disorder has sometimes been called ‘imagined ugliness.’
—The Mayo Clinic staff
Recent years have seen an increased awareness of plastic surgery patients with Body Dismorphic Disorder (BDD). One of the major concerns about patients with BDD is that they may not be competent to give an informed consent for the cosmetic procedures they elect to have.
A medical malpractice lawsuit involved a woman who, displeased with her abdominoplasty scars, claimed that she had been incapable of giving a genuinely informed consent because she had BDD. The case was later dismissed; the court ruled that the plaintiff’s surgeon had followed acceptable medical practice and did not have sufficient reason to refer the patient to a psychiatrist before surgery. The case does, however, highlight some of the problems BDD poses for informed consent when it comes to plastic surgery.
The legal definition of informed consent is rather broad, but it provides guidelines for determining the mental competency of the patient before they can consent to elective surgery. The law requires that doctors provide complete and accurate information about the procedure and its risks to the patient, and the patient must not be coerced or pressured in any way. Ultimately, a truly competent patient must be capable of refusing consent to surgery.
When a psychological disorder (such as BDD, dementia, a learning disorder, or a manic episode) prevents a patient from understanding the risks and likely result of a surgery they wish to have, the question arises as to whether their consent is legitimate. Although a patient’s consent cannot be retroactively revoked if they are diagnosed with BDD after surgery, plastic surgeons are always on the watch for signs of BDD when consulting with prospective patients. This is especially important in the field of plastic surgery because people with BDD are very likely to seek surgical solutions to what they believe is wrong with them.
At the Pacific Center for Plastic Surgery, our goal is to provide patients with lasting, satisfying results. An important step in achieving this goal is making sure that our patients are psychologically healthy enough to make an informed, rational decision in their choice to have plastic surgery.
Source: Informed Consent in Body Dysmorphic Disorder, Medscape Medical News
Post operative nausea and vomiting (PONV) is a serious problem for patients who are undergoing elective surgery. For facial aesthetic surgery PONV can lead to hematoma, delayed healing times, and other complications not the least of which is patient suffering.
Our focused interest in this problem was motivated by the progressive increase of PONV despite liberal use of antiemetics such as Odansetron (Zofran). At the same time we noted the increasing prevalence of antidepressant medications taken by our patients.
Based on our experience and extensive review of the literature we have established a perioperative treatment protocol that is beneficial to your patients and their well being.
Serotonin Syndrome is a poorly recognized but potentially dangerous condition which in its early stages may include nausea and vomiting (PONV) , hypertension, fever, tachycardia, agitation, restlessness, insomnia, mental status changes, diarrhea, etc. All of these are dangerous in the post operative healing period.
Serotonin Syndrome occurs when two or more drugs are taken together and cause too much available serotonin. Antidepressants (including selective serotonin reuptake inhibitors (SSRI), selective serotonin/norepinephrine reuptake inhibitors (SSNRI), and monamine oxidase inhibitors (MAOI); Migriane Triptan medications including Imitrex, Relpax and others. Pain medications: (especially Tramadol), opioids; antiemetics such as odansetron (Zofran); and even cough medicines with dextromethorphan have been implicated in Serotonin Syndrome.
When your patients, who have been appropriately prescribed these medications, are then given certain pain medications or antiemetics they may develop serotonin syndrome and PONV.
We are attaching a table listing some of the multiple drug classes that have been implicated in this syndrome. In order to keep Serotonin Syndrome from occurring in our patients, we use the protocol attached. This includes the use of Cyproheptadine (periactin) as prophylactic when serotonin medications are used.
We your taking note of these guidelines during the postoperative period and contact us directly if you have any concerns or suggestions.
In addition to its adverse effects on general health, smoking tobacco increases the chance’s of a plastic surgery patient having complications and can negatively affect her results.
Dr. Nichter at the Pacific Center for Plastic Surgery would like to advise prospective patients of the dangers of smoking as they relate to plastic surgery.
A good plastic surgery result relies on good blood flow. The nicotine, carbon monoxide, and hydrogen cyanide in the blood of smokers inhibits their blood’s ability to deliver sufficient oxygen to their healing tissues. Thus, patients who smoke are at greater risk of complications and poor wound healing.
A long history of medical studies have shown revealed the risks patients take when they smoke. A 1984 study, which followed 1,100 face lift patients, “found that a smoker was 12.46 times more likely to suffer skin loss than a patient who did not smoke.”
A more recent study in 2003 reviewed 132 abdominoplasty patients. The study “showed wound healing problems in 47.9% of smokers versus 14.8% of non-smokers.”
Whether a plastic surgery candidate smokes or not is a big factor in whether a surgeon will perform surgery on that person or not. At the Pacific Center for Plastic Surgery, patients will be asked about their smoking habits, if any, which will be factored into the doctor’s decisions in her/his case.
Source: Bulletin of the American College of Surgeons
The U.S. Preventative Services Task Force (USPSTF) recommends counseling to children and young adults (ages 10-24) with fair skin on the effects and dangers of ultraviolet (UV) light exposure.
Dr. Nichter of the Pacific Center for Plastic Surgery would like to make blog readers aware of this new recommendation, which is an update to USPSTF’s 2003 guidelines for physicians on counseling skin cancer patients.
Since 2003, the USPSTF has found evidence that counseling for children and young adults on the risks of UV light exposure is beneficial.
From the USPSTF:
Convincing evidence relates UV radiation exposure during childhood and youth to a moderately increased risk of skin cancer later in life; for adults, adequate evidence links UV radiation exposure to a small increase in the subsequent risk of skin cancer […] Individuals with a fair skin type are at greatly increased risk of skin malignancy.
Counseling encourages people to engage in behaviors that mitigate their UV exposure such as wearing effective sunscreen, reducing midday outdoor activities, wearing hats or UV-protective clothing, and avoiding the use of tanning beds.
Dr. Larry Nichter would like readers and patients to note that although questions remain as to the direct relationship between sun exposure to an increased skin cancer risk, the risk of premature skin aging (laxity, wrinkles, and an eventual leathery appearance) seems to be directly related to cumulative sun exposure without protection for all ages.
Prospective patients who are concerned about UV-induced skin aging should take a look at the skin rejuvenation treatments available at the Pacific Center for Plastic Surgery.
Want to enlarge or improve your breasts with your own fat?
For years, Plastic Surgeons and their patients have desired to transfer unwanted fat from their tummy or thighs to their breasts. We are now are able to do this safely.
If you have been considering a Breast Lift or improving your appearance after breast augmentation or Breast Reconstruction but are not comfortable with introducing artificial material into your body, you may want to look into the benefits of breast augmentation with fat transfer. An alternative to breast implants is fat transfer also known as fat grafting or lipoinjection. This technique allows women the option of enhancing the appearance of their breasts without the potential problems of saline or silicone implants such as hardness, rippling or rupture.
Who is a candidate?
Any woman who is healthy
Women with sufficient body fat for the procedure
Women considering breast augmentation who wish to be one cup size larger or less
Women who have had breast augmentation or reconstruction but who lack fullness or have contour concerns. Fat transfer can further enhance and reshape your breasts while smoothing out visible or palpable edges of breast implants. This will disguise implant rippling and wrinkling.
Women with normal mammography
Dr. Nichter has successfully transplanted fat into the face, buttocks and other body areas for decades and are now using this same technology to enhance breast shape and size. Plastic surgeons have been transplanting fat to the breast since 1995 but caution and study were necessary to make sure there were not harmful effects. Furthermore, results in the past were variable, dependent on surgical equipment, technique, surgeon’s skill, and individual patients healing abilities.
Since 1995, recent advances have led to the development of special instruments made just for fat grafting. Dr Nichter uses his decades of experience and advanced knowledge of this technique to transfer body fat from other unwanted areas to the breasts. Though this procedure is still considered investigational to a degree, more and more qualified plastic surgeons are using this technique successfully. The advantage of this technique is its ability to create a natural augmentation without an implant. Fat grafting (also called lipoinjection or fat transfer) to the breasts is indicated for different reasons: as an alternative to implants for mild to moderate breast augmentations, to provide fullness to the upper part of the breast during a breast lift, after pregnancy, age, or weight loss, following breast reconstruction, or to minimize the visibility or rippling of existing breast implants. Typically up to one breast size enlargement is possible in most patients. Fat transfer to the breast is usually done as a single procedure resulting in approximately half a cup volume increase. In women desiring additional breast enhancement a subsequent procedure can be performed. Each surgery consists of two components:
Harvesting the fat: Fat is removed from your abdomen, hips, “love handles” or other areas using a fine cannula similar to the one used for liposuction but skinnier. This fat is rinsed with sterile saline solution and then packaged into syringes and prepared for transfer. Approximately 20% of fat removed is suitable and available for fat grafting.
Fat transfer into the breasts: The prepared fat is injected in small amounts at a time and widely distributed within the layers of the breast so that these living fat cells can pick up a healthy new blood supply.
Advantages of Fat Transfer to the breasts:
Fat cells are natural and you are using your own tissue without any foreign body or implant.
Harvesting of the fat by liposuction has the added benefit to enhance your shape by removing unwanted fatty deposits
The breast can be shaped or sculpted in more detail than is possible using implants alone.
Minimal incisions reduce the possibility and degree of scarring
No implant is used, therefore there is never a need for replacement, or any potential for capsular contracture (hardening of the implant).
Fast Recovery Time: Recovery time is about 1 week and usually less uncomfortable from implants that are placed beneath the muscle.
Although, breast augmentation performed with the lipoinjection technique takes longer than traditional breast augmentation (with implants) the benefits are substantial including no need for implant replacement in the future.
In the past, significant questions were raised about the ability of Mammograms or MRI to detect breast cancer after injecting fat into the breast. However, there is no evidence that fat transfer to the breast is less safe than any breast surgery. Large studies have begun over the last several years to study fat grafting to the breast. With or without breast surgery, calcifications and lumps can occur. Breast diagnostic studies including physical examination and mammograms should be used to monitor every patient diligently using standard guidelines.
As a general rule, surgeons with extensive experience in grafting large volumes of fat to the body are most likely to obtain the best results. We believe fat transfer should only be performed by surgeons certified by the American Board of Plastic Surgery that have experience in fat grafting. Few plastic surgeons have this experience. This ensures that your surgeon has advanced knowledge and technical familiarity, but also the subtle anatomy and aesthetics of breast augmentation.
Our patients remain the biggest source of our referrals. Over time they continue to remain thrilled with their results from these and similar procedures. I continue to share their enthusiasm and appreciate their long lasting rejuvenation which seems to affect them inside and out.
—Larry S. Nichter, MD, MS, FACS
For more information about the No Implant Breast Augmentation by fat grafting or other cosmetic procedures performed by Dr. Nichter call our office number: (949) 720-3888.