Surgeons from UC Davis Medical Center have demonstrated that artificial muscles can restore the ability of patients with facial paralysis to blink, a development that could benefit the thousands of people each year who no longer are able to close their eyelids due to combat-related injuries, stroke, nerve injury or facial surgery.

In addition, the technique, which uses a combination of electrode leads and silicon polymers, could be used to develop synthetic muscles to control other parts of the body. The new procedure is described in an article in the January-February issue of the Archives of Facial Plastic Surgery.

“This is the first-wave use of artificial muscle in any biological system,” said Travis Tollefson, a facial plastic surgeon in the UC Davis Department of Otolaryngology – Head and Neck Surgery. “But there are many ideas and concepts where this technology may play a role.”

In their study, Tollefson and his colleagues were seeking to develop the protocol and device design for human implantation of electroactive polymer artificial muscle (EPAM) to reproducibly create a long-lasting eyelid blink that will protect the eye and improve facial appearance. EPAM is an emerging technology that has the potential for use in rehabilitating facial movement in patients with paralysis. Electroactive polymers act like human muscles by expanding and contracting, based on variable voltage input levels.

For people with other types of paralysis, the use of artificial muscles could someday mean regaining the ability to smile or control the bladder. Reanimating faces is a natural first step in developing synthetic muscles to control other parts of the body, said UC Davis otolaryngologist Craig Senders.

“Facial muscles require relatively low forces, much less than required to move the fingers or flex an arm,” said Senders.

Blinking is an essential part of maintaining a healthy eye. The lid wipes the surface of the eye clean and spreads tears across the cornea. Without this lubrication, the eye is soon at risk of developing corneal ulcers that eventually can cause blindness.

Involuntary eye blinking is controlled by a cranial nerve. In most patients with permanent eyelid paralysis, this nerve has been injured due to an accident, stroke, or surgery to remove a facial tumor. Many have no other functioning nerves nearby that can be rerouted to close the eyelid. Others were born with Mobius syndrome, characterized by underdeveloped facial nerves. These patients are expressionless and can neither blink nor smile.

Eyelid paralysis currently is treated by one of two approaches. One is to transfer a muscle from the leg into face. However, this option requires six to10 hours of surgery, creates a second wound, and is not always suitable for elderly or medically fragile patients.

The other treatment involves suturing a small gold weight inside the eyelid. The weight closes the eye with the help of gravity. Though successful in more than 90 percent of patients, the resulting eye blink is slower than normal and cannot be synchronized with the opposite eye. Some patients also have difficulty keeping the weighted lid closed when lying down to sleep. In the United States, an estimated 3,000 to 5,000 patients undergo this surgery every year and therefore might benefit from an alternative treatment.

For their study, Senders and Tollefson used a novel alternative method for eyelid rehabilitation in permanent facial paralysis. They used an eyelid sling mechanism to create an eyelid blink when actuated by an artificial muscle. Using cadavers, the surgeons inserted a sling made of muscle fascia or implantable fabric around the eye. Small titanium screws secured the eyelid sling to the small bones of the eye. The sling was attached to a battery-operated artificial muscle. The artificial muscle device and battery were into a natural hollow or fossa at the temple to disguise its presence.

Senders and Tollefson found that the force and stroke required to close the eyelid with the sling were well within the attainable range of the artificial muscle. This capability may allow the creation of a realistic and functional eyelid blink that is symmetric and synchronous with the normal, functioning blink. A similar system also could give children born with facial paralysis a smile.

The three-layered artificial muscle was developed by engineers at SRI International of Palo Alto, Calif., in the 1990s. Inside is a piece of soft acrylic or silicon layered with carbon grease. When a current is applied, electrostatic attractions causes the outer layers to pull together and squash the soft center. This motion expands the artificial muscle. The muscle contracts when the charge is removed and flattens the shape of the sling, blinking the eye. When the charge is reactivated, the muscle relaxes and the soft center reverts back to its original shape.

“The amount of force and movement the artificial muscle generates is very similar to natural muscle,” Tollefson said. An implanted battery source similar to those used in cochlear implants would power the artificial muscle.

For patients who have one functioning eyelid, a sensor wire threaded over the normal eyelid could detect the natural blink impulse and fire the artificial muscle at the same time. Among patients lacking control of either eyelid, an electronic pacemaker similar to those used to regulate heartbeats could blink the eye at a steady rate, and be deactivated by a magnetic switch.

The Associated Press: “The White House and Senate Democrats have turned to a proposal to tax breast implants, tummy tucks, wrinkle-smoothing injections and other procedures as they search for ways to pay for costly health care overhaul plans.” The Senate health bill, which was unveiled Wednesday by Senate Majority Leader Harry Reid of Nevada “would slap a 5 percent excise tax on elective cosmetic surgeries and procedures to help pay for expanding coverage to the uninsured.” The national tax is projected to raise $6 billion over 10 years (Hirschfeld Davis, 11/19).

Kaiser Health News: “Plastic surgeons decried the proposal, saying their practices were battered by the recession and are just beginning to recover. … About 12 million cosmetic procedures and surgeries – which typically aren’t covered by insurance – were performed last year, at a total cost of $10.3 billion, according to the American Society of Plastic Surgeons.” The tax is already levied at a rate of 6 percent per procedure in New Jersey (Galewitz, 11/19).

Roll Call reports that the president-elect of the American Society of Plastic Surgeons said the tax may not raise that much because “revenue estimates from the tax might be overstated since the demand for plastic surgery has fallen by between 30 and 45 percent recently because of the recession.” The president-elect said 60 percent of women who get cosmetic surgery have annual incomes between $30,000 and $90,000. “The tax is not included in the House health care bill, which is largely funded by new taxes on higher income people” (Roth, 11/19).

The Wall Street Journal: “The tax is on elective procedures, and would not apply to any procedure to correct birth defects or issues arising from disease, accidents or trauma” (Mundy, 11/19).

The University of Alabama at Birmingham (UAB) Department of Dermatology is offering a new non-surgical, needle-free skin-tightening procedure that doctors say smoothes wrinkles, firms up baggy or loose skin and improves body contours.

The outpatient cosmetic procedure is performed with Thermage®, a device that contours skin all over the body face, eyelids, neck, abdomen, arms, legs and more using focused radio waves.

“Thermage emits radio waves that travel very deeply into the skin and the subcutaneous tissue to promote collagen remodeling and help tighten skin,” says Marian Northington, M.D., a UAB assistant professor of dermatology and expert in cosmetic skin procedures.

“Thermage works well on patients who want a younger appearance and improved skin tone without relying on surgery, injections or chemical applications,” Northington says. “It is safe for all skin types, light skin and dark skin, and it works well for all body areas.

“You get some immediate tightening that occurs after treatment, and then the skin continues to improve subtly over time by getting tighter and firmer for up to four to six months.”

Thermage treatments can usually be performed in one or two sessions lasting from 20 minutes to more than an hour, depending on the treatment area. Anesthesia is not required. A dermatologist can advise if multiple treatments are needed based on patient preference, treatment area and other factors.

During a Thermage treatment, a slight warmth on the skin signals that radiofrequency energy is being absorbed. This warmth indicates that collagen is being stimulated and tightened, Northington says. Afterward, the treated skin may be slightly red for a day or two; the patient’s work schedule, daily routines and sun exposure can remain unchanged.

The Thermage treatment system is approved for the non-invasive treatment of wrinkles and eyelids and to improve the appearance of cellulite. Thermage is made by Solta Medical Inc. of Hayward, Calif.

Police in Peru have arrested four people, three men and a woman, whom they allege are members of a gang suspected of killing up to 60 people in order to extract their body fat to sell for thousands of dollars a litre to foreign markets to make cosmetics.

According to a report published in the national newspaper Perú 21 on Thursday, the gang, known as “Los Pishtacos” named after a demon who according to Andean tradition killed people to rob them of their body fat, were operating in the provinces of Huánuco and Pasco, inland from neighbouring Lima.

The National Police of Peru (PNP) first came across evidence of the gang’s work when they seized a store of human fat on 3rd November at the warehouses of a company called Estrella Polar in the capital, Lima.

They also arrested two of the suspects there, along with a gun and drugs. The police started the investigation after receiving reports that human fat was being shipped from the mountains to the capital.

The fat was stored in used soda and water bottles, which the police showed to reporters, said a Reuters news agency report.

After further investigation, the PNP determined that the detainees were members of a “murder for profit” organization and despatched 23 specialist detectives to search for other members of Los Pishtacos in villages in the provinces of Huánuco and Pasco. They subsequently arrested two more suspects.

According to Perú 21, the authorities believe the gang has been operating for several years and is responsible for the disappearance of 60 farmworkers and villagers, including children. They are trying to trace at least 7 other members of the gang, who are thought to be hiding in the mountains of Huánuco.

At a news conference in Lima, police showed reporters two bottles of fat they had recovered from the suspects and a photograph of the head of one of the gang’s victims. They said one of the suspects had led them to the head, recovered in a valley last month.

According to a report by the Associated Press, the Peruvian police said one of the suspects had described to them how they would cut of the heads, arms and legs of their victims, take out their organs and hang the torsos from hooks above candles to warm the flesh so the fat could drip out into tubs positioned underneath.

Colonel Jorge Mejia, chief of Peru’s anti-kidnapping police, told the press that two of the suspects were carrying bottles of liquid fat when they were arrested, and had told the police it was worth 15 thousand (US) dollars a litre.

In the meantime the four detainees are being held in the capital, Lima, and have been accused of “homicide for reasons of profit”. The authorities have not ruled out that the gang may also be involved in organ trafficking.

Reuters reported that Police Commander Angel Toldeo told the press:

“We have people detained who have declared and stated how they murdered people with the aim being to extract their fat in rudimentary labs and sell it.”

The police said the suspects had told them they sold the fat to middlemen in Lima, whom the authorities suspect were selling it to cosmetic companies in Europe, although they presented no evidence of any sales.

In the meantime, medical experts are expressing doubts that a major black market for human fat exists, although it can be used to make cosmetics.

A dermatology professor at Yale University in the US, Dr Lisa Donofrio told the Associated Press (AP) that it was possible that there is a small market for human fat to make products to keep skin supple, but she referred to the science behind it as “pure baloney”.

Other experts contacted by the AP said they were sceptical about a black market for human fat because it was so easy to get hold of legally from people willing to donate it, and in many instances, such as anti-wrinkle treatments, the fat is taken from the patient’s own body, such as the stomach or buttocks, because this reduces the risk of life-threatening immune system reactions.

A special edition of the journal, Clinical Risk, published by the Royal Society of Medicine, looks at how the combination of an under-regulated market, “professional greed”, increased marketing and overwhelming media hype have created a “perfect storm” that threatens patients and practitioners alike. The journal’s editor argues that cosmetic surgery patients in the UK are at more risk than ever before.

Dr Harvey Marcovitch, who commissioned leading experts in the field to write for this special issue said, “Patient safety is this journal’s main aim and there can be no area of medicine where patients in the UK are more in need of protection. We need tight control of advertising of cosmetic surgery – including internet advertising. We need proper regulation of the industry and we need both surgeons and GPs to manage patient expectation.”

In one paper, entitled ‘Clinical Risk in Aesthetic Surgery’, Nigel Mercer, consultant plastic surgeon and President of the British Association of Aesthetic Plastic Surgeons (BAAPS) argues: “We have reached a stage where public expectation, driven by media hype and, dare one say, professional greed, has brought us to a ‘perfect storm’ in the cosmetic surgical market.”

He adds, “There has been a massive increase in ‘marketing’, including discount vouchers, 2-for-1 offers and holidays with surgery! In no other area of medicine is there such an unregulated mess. What is worse is that national governments would not allow it to happen in other areas of medicine. Imagine a ‘2-for-1′ advert for general surgery? That way lies madness!”

Highlights:

Clinical Risk in Aesthetic Surgery: Nigel Mercer discusses the role of the media and advertising and calls for tighter regulations in the UK, comparing this country’s lack of regulation with the Food and Drug Administration’s role in the US.

Key quotes:

- “Perhaps, like tobacco, there should be a Europe-wide ban on advertising all cosmetic ’surgical’ procedures, including on search engines…”.

- “If we have to sell anything, we should sell our advice, not procedures. If we cannot self-regulate, then, like the financial institutions, regulation will eventually be imposed…”

- “All cosmetic treatments are medical interventions, and every medical intervention has a complication and failure rate. Consequently, there are no ‘consumers’ or ‘clients’ but only ‘patients’…”

- “Perhaps the single most important factor in reducing clinical risk in cosmetic surgery is the motive for performing any procedure must never be financial gain, so I suggest we get our act together as an industry as we are in grave danger of biting the hand that feeds us.”

France Sets Standards for Practice of Aesthetic Surgery: French consultant plastic surgeon, Alain Fogli describes the strictly defined guidelines for cosmetic surgery in France which include:

- Surgical procedures can only be undertaken by surgeons who are registered specialists and deemed competent. Possession of a general medical degree, and the fact that the practitioner is ‘experienced’ are not deemed to be sufficient qualifications

- A ban on all forms and methods of publicity and advertising, direct or indirect, in whatever form, including the Internet

Minimizing Risk in Aesthetic Surgery: Foad Nahai, President of the International Society of Aesthetic Plastic Surgeons (ISAPS) and former president of the American Society of Aesthetic Plastic Surgeons (ASAPS) describes how to minimise risk in each facet of ‘the safety diamond’: patient, facility, procedure and surgeon.

He tells readers:

“Regulations governing the training of all cosmetic surgeons are sorely needed. Governments are reluctant to become involved, as they see this issue as a ‘turf battle’ between various physician groups and not a public safety or patient safety issue. However, there is no question that this is a patient safety issue of paramount importance and I take our governments to task for not addressing it.”

- Since by law any physician is allowed to practise cosmetic surgery, attempts by individual physicians or plastic surgery organisations to restrict those who are not qualified is viewed as a restraint of trade.

Improving the Safety of Aesthetic Surgery: Recommendations Following a 14-Year Review of Cases to the Medical Defence Union (1990-2004): Consultant plastic surgeon and BAAPS Secretary, Rajiv Grover, reveals a 14-year audit of claims to the MDU which shows why patients sue. He provides recommendations to avoid these situations such as careful pre-operative counselling, thorough documentation and exploring with the patient what degree of correction and scarring is realistic – and not being falsely optimistic about the likely outcome.

Managing Risk to Reputation: Magnus Boyd, Partner at leading UK solicitors, Carter-Ruck suggests how doctors can protect their reputation and how the media can influence the outcome of a professional investigation or the expression of anger from a disgruntled patient.

Both Dr Harvey Marcovitch and Mr Nigel Mercer are available for comment.

Clinical Risk

The journal Clinical Risk aims to give both medical and legal professionals an enhanced understanding of key medico-legal issues relating to risk management and patient safety, through authoritative articles, reviews and news on the management of clinical risk. The AvMA Medical and Legal Journal and the Healthcare & Law Digest, both included within Clinical Risk, contain articles on current medico-legal issues and reports on a wide range of recently settled clinical negligence cases.