Sydney ~ Friday, 11 November 2011
The body in the beauty parlour
By Jocelynne Scutt
The idea that women’s bodies can be allowed to walk the streets, exist in the paid workplace, or appear anywhere in public without enhancement or embellishment is becoming less and less acceptable. Once, make-up and false bosoms were a signal that a woman was either on the stage, haunting the backstreets in hope of a paying customer, or appearing in movies labelled ‘porn’. In the 21st century, they are signifiers of ‘mainstream’ woman.
Intelligence via a ‘team of scientists and psychologists’ from Harvard and Boston Universities and the Dana-Farber Cancer Institute says women wearing make-up are perceived as ‘more competent, attractive, likeable and trustworthy’. The study contends this follows whether women are made-up in a ‘natural’, ‘professional’ or ‘glamorous’ style and whether the images are flashed before the studies’ subjects eyes or viewed for more lengthy periods.
Funded by Procter and Gamble, a huge conglomerate making its money through selling cosmetics (mainly to women), the study is labelled ‘independent’ so must be believed – at least, this is the thrust. Hence, comes the message, to get on in business or succeed in professional life, after spending-up at cosmetic counters all over the country women had better get out the make-up palette.
So have we ‘come a long way baby’, or are women inexorably enmeshed in a culture that sees artifice as more acceptable than the reality of women’s physiognomy? Are women’s real bodies ‘out’, whilst contrivances projected as ‘real’ women constitute the ‘perfection’ and ‘beauty’ for which (once) real women must aim?
In the 1970s, a raft of books and articles appeared as an antidote to the rejection by the Women’s Movement of lipstick, bras and ‘step-ins’ (a modified corset or girdle), and the replacement of stockings and suspenders with pantyhose. Marabel Morgan’s The Total Woman, selling more than ten million copies, was perhaps the most popular. She advocated that women enfold themselves in saran wrap (a transparent plastic used to preserve left-over food) when greeting a husband just home from work. An alternative was to spread oneself liberally in jam or honey whilst making supper for a husband lying prone on couch or carpet watching evening television. In this context, ‘wife’ was supposed to equal ‘supper’.
Although the book and her accompanying seminars had a massive audience, it is doubtful that many women went to the lengths Marabel Morgan suggested. Yet perhaps a return to her methods of feminine enhancement would be less damaging to women than a visit to today’s beauty parlours, and extraordinary though it may seem even less dangerous or humiliating, as well as less expensive.
A woman doesn’t need to enter a beauty parlour to be regaled with methods and mechanisms for ‘becoming beautiful’. In London, venturing into a large department store in Bond Street means being assailed on all sides by ‘product’ representatives bearing potions, lotions and pastes in tubes, jars and containers of all dimensions, or brandishing hair-wands, lash-curlers or body-shapers of all sorts and sizes. Venturing into the Grand Arcade in Cambridge brings with it a need to avoid salespeople imploring passersby to sample a wide variety of perfume, cosmetics and ‘beauty treatments’. Australian capital cities carry their own brand of cosmetic confrontation, with department store refurbishment seeing the make-up and perfume counter as necessarily at the forefront of luring the customer.
Meanwhile, beauty parlours adopt more and more fanciful methods of pampering the body, more and more ways of ensuring that women’s pockets and purses open wide in the search for the perfect body, the face of beauty, according to conventional diktat.
Want puffed-up lips? This comes not by the sting of a bee, but through the injection of ‘chemical fillers’, or agitating the lips with capsicum or chilli. Collagen and more recently developed products using hyaluronic acid operate akin to scaffolding, although ‘care must be taken’ to avoid ‘creating ridges’ giving the mouth ‘an ugly edge’. Silicone implants or ‘Permalip’ last longer though they cost twice as much: $2,000 as opposed to $1,000 for several months of a protuberant pout. Then it’s back to the beauty (sic) parlour to be relieved of another hefty sum.
What about an end to wrinkles? This requires a good dose of botulism or, as advertised, its commercially named Botox. Rather than the death that follows upon a botulism bout, Botox targets ageing’s most visible facial indicator. Of course, this costs, too. Yet perhaps rather than the monetary outlay, the so-called ‘side’ effects should be centre-stage. Lessening or alleviating frown-lines may cause life-threatening conditions that, once detected, even at their most mild stage, dictate an immediate call to the doctor or the nearest hospital’s emergency department.
* Problems with swallowing, speaking or breathing, caused by weakening of facial or throat muscles;
* Loss of strength and ‘all-over muscle weakness’, as well as double or blurred vision, ‘drooping or swelling’ eyelids, dry eyes, loss of capacity to speak, hoarseness or inability to articulate clearly, loss of bladder control;
* Dry mouth, discomfort or pain at the site of injections, tiredness, neckpain, headaches;
* Allergic reactions including ‘itching, rash, red itchy welts, wheezing, asthma symptoms, dizziness or feeling faint’.
Still, says one Botox website, ‘no confirmed serious case of spread of toxin effect’ has been reported from between-the-eyes botoxing. Nonetheless, if these symptoms occur, a sufferer ought not to ‘drive a car, operate machinery, or do other dangerous activities’. Readers may wonder about ‘unconfirmed’ serious cases, and what classifies as a confirmed ‘non-serious’ case, but merely receives advice that the ‘potential risk of spreading viral diseases’ such as Creutzfeldt-Jakob Disease via human albumin, present in Botox, is ‘extremely rare’: ‘no cases of viral disease or CJD’ have ‘ever’ been reported ‘in association with human serum albumin’.
Silicone breast implants have already been subject to extensive litigation, with ‘wins’ and potential lawsuits for those afflicted by splitting silicone sacs resulting in silicone seeping through the body and into the muscles, silicone sac slippage with a consequence of lumps and bumps in the oddest of places, and even more damning consequences said to accrue to babies breastfed from silicone-filled bosoms.
Apart from these more serious body-beautiful impacts, women are invited to undergo other ‘ treatments’ in the name of bodily improvement. Dolly Parton is quoted as saying that the enormously long appendages colourfully attached to her fingers are acrylic nails: ‘Of course they’re not real…’. This involves hours spent affixing, painting, drying, and all essential, now, to cover-up the real nails damaged by the false copies that can never truly be mistaken for the real thing.
Eyes and eyebrows do not escape. ‘If the eyes are the window to the inner-beauty, then the eyebrows are the frame’, is the slogan used to promote eyebrow threading. This is the method introduced to replace eyebrow waxing. Superfluous hairs are removed from the eyebrows to create a shape said to enhance not only the eyes, but the face in its entirety. How is it done? The technician takes a length of thread, manipulating it through the eyebrows with a hand at one end and the technician’s mouth at the other. Those undergoing this treatment must endure a face thrust into one’s own, lips bared in a rictus grin, whilst the thread passes too and fro. Closing one’s eyes is, of course, one remedy. Another is to forgo eyebrow threading at all.
Not only the upper-reaches of the body are a target. Feet do not escape. The latest? Fish therapy. The beauty-seeker is enjoined to place her bare feet in a fish tank, where small fishes are programmed to nibble at the ‘dead’ flesh of the foot. Customers pay by the minute, with fifteen minutes advised as the minimum. Fewer minutes of exposure of feet to fish brings with it unsatisfactory results. Apparently the fish take this long to get into the swing of eating human flesh. For them, it proves to be an unsatisfactory diet: they require feeding on real fish food at the end of each day to maintain their good health and relieve their owners from charges of animal starvation and cruelty.
Body parts in between feet and legs, hands and face, do not escape beauty parlour rigours. The most famous, or infamous, of the temporary treatments is, perhaps, the Brazilian. This is an advance on the bikini wax and the half-Brazilian, all of which concentrate upon pubic hair. Waxing-the-pubes has now travelled beyond the bikini model and ‘Super model’ to the young-woman-about-town and some of her older counterparts. Pubic hair is razored to a quarter-inch, talcum powder is spread over the remaining growth, hot wax is applied liberally with a balsa paddle, then gauze strips are pressed down, to be wrenched off at a rapid rate, taking the hair with them.
A bikini wax takes only those hairs protruding below or above the bikini-line, at the Mound of Venus (depending upon the width of the bikini) and at the groin. A Brazilian (or ‘full’ Brazilian) takes all the hair from the whole of the pubic region, hair is removed ‘in the front, back and everything in between’. A part-Brazilian leaves a ‘landing strip’ of hair bisecting the Mound of Venus. A ‘Hollywood’ takes hair from the pubic region and between legs and buttocks. Fifteen minutes to half an hour is required, and after three to six weeks the whole exercise must be endured yet again. Yet women must not despair: it’s apparently most painful the first time, and thenceforth reduces in pain levels, although painkillers or pills with an anaesthetic capacity are recommended prior to undergoing the treatment. .
All these measures are aimed at beautification, perfection, enhancement and, most importantly, anti-ageing. Women are instructed to get on the anti-ageing wagon post haste. ‘It’s never too soon’, runs the slogan. Women in their teens are bombarded with messages online, on billboards and radio and television, as well as through text messages. Facebook and Twitter sites abound with advertisements for top to toe treatments to be applied at home or in commercial establishments. Posters, pictures and images of women tell the story: whether ‘personalities’, ‘stars’ or ‘society’, the more artificial, the more attractive. This, at least, according to dominant cultural norms as relayed through the media.
As women rise on the one hand: prime ministers, premiers, cabinet ministers, secretaries of state and ‘hard’ government departments, board members, chair-of-board, head of conglomerates and personal fortunes, women disappear on the other, replaced by infantilised beings.
As the beauty industry makes its millions out of making women dissatisfied with who we really are, men receive the message that women are really not to be feared as equals. The image of the serious woman, strong leader, person of depth and fortitude, power and presence, is undercut by that of the naked pudenda.
No, you haven’t come a long way baby, or maybe ‘baby’ has. Has baby taken over? The grown woman, wrinkle-free and puff-lipped, hairless (in all the ‘right places), prepubescent or, at most, only-just pubescent. The female bosom is the sole adult signifier remaining. And even this is no longer to be real, but man-made. For women, the message comes loud and clear. Our bodies are no longer to be our own.
Melbourne ~ November 13, 2011
Dentists give patients Botox beauty boost
By Jill Stark
By law, Botox can only be administered by doctors. (Quentin Jones)
DENTISTS are giving their patients Botox injections and lip enhancements for cosmetic purposes, despite regulations stating they should only use the procedures to treat dental problems.
Myles Holt, a dentist who heads the Australian Academy of Dento-Facial Aesthetics, says he has trained more than 150 Australian and New Zealand dentists to inject Botox and dermal fillers into a patient's lips, cheeks, forehead and gums.
Under rules set by the Dental Board of Australia, dentists should only use Botox to treat a condition which causes facial pain and teeth grinding.
The toxic protein, derived from the botulinum bacteria, works by weakening targeted muscles. This can ease spasms, tension and pain, as well as reduce wrinkles and other signs of ageing.
The Sunday Age understands that Allergan, the Australian supplier of Botox, is receiving daily calls from dentists who want to buy the drug, many of whom have taken Dr Holt's course.
''I currently administer Botox to my patients, mainly because I and my patients were dissatisfied with the results received elsewhere and we knew we could get better results by combining our cosmetic dentistry with enhancing the surrounding tissues all in one place and at one appointment,'' Dr Holt said.
''We had numerous cases where patients' dentistry was affected by the poor lip enhancements they received from GPs who didn't understand the nuances of smile design.''
Allergan insists it supplies the restricted drug in accordance with the dental board's policy, but Dr Holt, who freely admits to using it for cosmetic purposes, says the pharmaceutical company is his main supplier.
By law, Botox is only allowed to be administered by doctors, and nurses who are under the supervision of a doctor, if they can prove a ''therapeutic need''. However, it is widely used for cosmetic purposes.
Dr Holt says dentists have superior knowledge of facial anatomy and has lodged a complaint with the dental board about its ''fundamentally flawed'' rules, arguing the use of Botox by dentists is common practice in Asia, the US and parts of Europe.
''In the past we would do large dental cosmetic cases and then find we'd have to refer them off for treatments that would enhance that or improve the soft tissues around the mouth, and it just really didn't make sense,'' Dr Holt said.
''Dentists are equally if not more qualified to be doing these procedures than their medical counterparts.''
Doctors argue dentists lack the medical training to give Botox injections.
Gabrielle Caswell, president of the Cosmetic Physicians Society of Australasia, said a patient's full medical history must be taken before the drug is administered.
''It is a medical procedure, not a dental procedure, and there are enough trained medical practitioners who can do it, so there's really no need for dentists to be doing it,'' Dr Caswell, said
However, Dr Holt said doctors were only concerned about dentists encroaching on their turf. He said doctors also freely administer Botox for cosmetic purposes despite laws stating a therapeutic need must first be established.
''The industry amongst medical practitioners and nurses is poorly regulated and controlled,'' he said.
''They realise dentists will have an advantage in providing these treatments and do not have a single scientifically based logical reason why dentists should not.''
A spokeswoman for the Dental Board of Australia said it expected ''registered practitioners to comply with the standards and policies set by the board''.
CommonHealth ~ November 4 2011
Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh
By Rachel Zimmerman
On a rainy night in early September, six women gathered for dinner at a Macaroni Grill restaurant in Gaithersburg, Maryland. They had come from around the country: Utah, Georgia, Florida, New York, Texas. But their mood wasn’t festive. All six were in town to speak publicly about their personal medical traumas in front of an advisory panel for the U.S. Food and Drug Administration.
Between them, the women figured they had undergone 45 surgical procedures to try to undo the damage resulting from vaginal surgery using synthetic mesh devices. The mesh implants were supposed to free them from the intimate discomforts that millions of women face after childbirth and as they age: pelvic organ prolapse, in which stretched, weakened tissues can allow the bladder or other organs to sag or bulge into the vagina, and stress urinary incontinence, which can lead to involuntary leakage with every laugh or cough. Once implanted, the hammock-like mesh was meant to shore up the supportive pelvic tissues and help keep sagging organs in place.
But rather than fix their problems, the mesh led to a range of far more awful complications. For some, the material eroded through the vaginal lining, causing infections and nerve damage, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and a halt to their sex lives.
“I was in the most horrendous pain I’ve ever experienced,” said Amy Gezon, a 43-year-old mother of three and one of the women who testified before the FDA advisory panel. “I finally ended up in the ER after expressing a desire to end my life just to escape the pain. If I knew one-tenth of the information out there in the literature…I would have never consented to this surgery.”
A Higher-Risk Device
The FDA, which has already detailed the serious complications linked to vaginal mesh surgery in a series of public health alerts – one in 2008 and an update this summer – is now considering reclassifying some of the devices into a higher-risk category that would require more evidence of safety and effectiveness, including clinical studies. A total recall of the products is unlikely dozens of various mesh “kits” made by numerous manufacturers are on the market.
The FDA says it will make a final decision after analyzing the testimony and documentation from its advisory panel meetings in September.
Even the mesh manufacturers say they support some kind of regulatory action. Jeff Secunda, vice president for technology and regulatory affairs for medical device industry trade group AdvaMed (The Advanced Medical Technology Association), said in a statement:
“Industry remains committed to ensuring physicians and patients have appropriate information on transvaginal mesh products…In addition to the existing body of evidence supporting current products, industry supports the collection of additional clinical evidence for new transvaginal mesh devices (premarket review) and existing transvaginal mesh devices (postmarket surveillance), specifically transvaginal mesh used to treat pelvic organ prolapse. In follow-up to the FDA advisory panel hearings in September, representatives of surgical mesh manufacturers are working to arrange a meeting with FDA to further review the group’s recommendations for collecting this additional clinical evidence.”
But whatever the federal regulators decide, the proliferation of vaginal mesh has already created a major uproar in medical and legal circles and among women simply trying to cope with the tribulations of aging.
Some doctors are accusing the gynecological surgery industry of compromising patient safety for profits. Highly trained pelvic surgeons suggest that their less-specialized gynecologist colleagues are partly to blame. At the same time, hundreds of lawsuits have been filed against the makers of vaginal mesh products charging that the devices are faulty and the risks were buried under a frenzy of marketing. And consumer advocates are calling for an end to the regulatory process that allowed these devices on the market in the first place.
Clearance vs. Approval
First, some numbers: In 2010, there were at least 100,000 pelvic organ prolapse repairs using surgical mesh, and about 75,000 of those were transvaginal procedures, according to the FDA. Additionally, the agency estimates there were about 260,000 surgeries for female stress urinary incontinence, with an estimated 206,000 of those involving a surgical mesh “sling” placed under the urethra. Most of these mesh devices are composed of non-absorbable synthetic polypropylene.
Many medical devices, including the mesh products now under scrutiny, are not required to go through the rigorous approval process that drugs must face in order to win FDA approval. The language is even different: drugs are “approved,” devices are “cleared” through what’s called the 510(k) process, which simply requires that the new device is shown to be “substantially equivalent” to a comparable device already on the market.
Under this scenario, there are generally no gold-standard safety and efficacy trials; no tests in humans. “That means it’s possible to have generations of products cleared on the basis of one predicate device that was itself never studied adequately,” Dr. Anne Weber, urogynecologist and former administrator of the Female Pelvic Floor Disorders Program at the National Institute of Child Health and Human Development wrote in a 2009 article on treating prolapse.
In a report this summer, experts at the Institute of Medicine characterized the FDA’s medical device clearance process as “flawed.”
The group Public Citizen, which petitioned the FDA to ban vaginal mesh for prolapse, wrote that the experience with these devices “provides a ‘poster-child’ example of the fundamental failure” of the current process. “Despite a complete lack of clinical data demonstrating that invasive mesh devices were reasonably safe and effective for transvaginal repair of POP [pelvic organ prolapse], these devices have been heavily promoted by industry and their highly paid physician consultants. As a result, tens of thousands of women have been seriously harmed, many permanently.”
Despite the emergence of a strong anti-mesh movement, moneyed interests, such as venture capitalists, are lobbying Congress to try to ease restrictions on all types of medical devices, according to recent reports.
A Brief History
Surgical mesh has been used to repair abdominal hernias since the 1950s, the FDA notes. In the 1970s, gynecologists started using mesh products for hernia to do abdominal repair of prolapse. Twenty year later, that practice grew to include mesh for stress urinary incontinence and ultimately, prolapse repair with mesh implanted vaginally.
At first, “surgeons would cut the mesh to the desired shape…and then place the mesh through a corresponding incision. Over time, manufacturers responded to this clinical practice by developing mesh products specifically designed for SUI and POP repair,” the FDA wrote in a overview posted in September.
Transvaginal surgery with mesh was considered a more straightforward procedure for doctors not trained in abdominal surgery, says Dr. Samantha Pulliam, associate director of the Division of Urogynecology at Massachusetts General Hospital in Boston. Also, the mesh could be implanted in women whose tissue was simply too weak to use on its own for “native” prolapse repair.
In 2004, the FDA says the first manufacturers were “cleared” to sell ready-to-use mesh “kits” for prolapse repair, which contained specialized tools, surgical instruments and pre-shaped mesh.
These kits were quickly adopted not only by urogynecologists who specialized in pelvic surgery, but also by increasing numbers of general gynecologists.
Joanne, a 77-year-old widow who lives outside Boston (and didn’t want her last name used) had severe constipation and a dropped bladder and bowel due to prolapse. In 2009, after vaginal surgery in which her doctor used one of the mesh “kits,” she says she’s had no problems, and just spent a month touring Australia.
A Recalled Product
But new questions about the FDA’s “clearance” process are now being raised. A recent Bloomberg investigation reports on a vaginal mesh device made by Johnson & Johnson (as well as mesh from other companies) “cleared” by the FDA based on its equivalence to an older product that was recalled in 1999: Boston Scientific’s ProteGen Sling. (J&J, which is facing lawsuits over vaginal mesh, told Bloomberg its mesh products are safe.)
The ProteGen “had never been implanted in a human vagina prior to its clearance,” wrote urogynecologist L. Lewis Wall, a professor at Washington University School of Medicine in St. Louis in an article published in the American Journal of Obstetrics and Gynecology.” The ProteGen, for stress urinary incontinence, was recalled due to its high complication rate; the FDA called it a “misbranded” and “adulterated” product, according to a 2002 investigation published in the New Jersey Star-Ledger. (I contacted Boston Scientific with more questions about this but they did not provide answers.)
An Implant Problem
Synthetic surgical mesh is used in many thousands of surgeries each year for prolapse and urinary incontinence, and also for hernia repair. But when mesh is permanently implanted through the vagina, it turns out, things can get complicated.
The very concept of transvaginal surgery using synthetic mesh “defies core surgical doctrines…”
Bay Area pelvic surgeon, Michael Thomas Margolis told the FDA’s advisory panel in September that the very concept of transvaginal surgery using synthetic mesh “defies core surgical doctrines” because the vagina is defined as “clean-contaminated” due to its normal flora, including Staph and E.coli bacteria, which “can not be surgically cleansed from the operative field.” Dr. Margolis, who says he’s done scores of “salvage” operations on women with mesh complications, wrote:
“The implantation of contaminated synthetic mesh through the vagina defies basic surgical tenets because by definition it is not performed in a sterile manner. In fact so-called “mesh erosion,” the most common mesh complication, is in reality “mesh infection with chronic wound breakdown.”
And removing mesh once it’s been implanted is also problematic. Here’s how Dr. Margolis described it:
What it’s like to remove mesh from the surgeon’s perspective can perhaps be appreciated by this analogy. Extirpation of vaginal mesh is akin to taking a hammer and chisel and trying to remove the rebar from a sidewalk while leaving the cement otherwise intact and not damaging the water mains and power lines below. It is difficult if not impossible to remove all the mesh and do it safely.
In addition to erosion through the vagina, the most frequent mesh complications are “pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems, [as well as] reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems,” the FDA reports.
The agency also describes mesh contraction as “a previously unidentified risk where the mesh shrinks in the body” [it is after all, placed in a body part that is designed to expand when needed] that can lead to “severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.”
With all the complications, you might wonder why vaginal mesh surgery has become so popular. Some experts say that if you want to know why, you have to follow the money.
Deleting The Word ‘Experimental’ In A Bulletin
If not for a controversial shift in an influential professional group publication, vaginal mesh surgery might have had a harder time gaining popularity. And some physicians say the underlying force behind the procedure’s spread is money. Back in February 2007 before FDA’s public health alert the American College of Obstetricians and Gynecologists issued a clinical practice bulletin on pelvic organ prolapse.
The February bulletin warned doctors and patients to consider the vaginal mesh procedure to be “experimental.” It said: “Given the limited data and frequent changes in marketed products (particularly with regard to type of mesh material itself, which is most closely associated with several of the postoperative risks, especially mesh erosion), the procedures should be considered experimental and patients should consent to surgery with that understanding.” (Bold is mine).
Seven months later, ACOG issued another bulletin on vaginal mesh surgery. This time, the word “experimental” was gone, in favor of what some might consider a softer warning: “Given the limited data and frequent changes in marketed products for vaginal surgery for prolapse repair (particularly with regard to type of mesh material itself, which is most closely associated with several of the postoperative risks, especially mesh erosion), patients should consent to surgery with an understanding of the post-operative risks and lack of long-term outcomes data.
Experimental procedures are often not covered by third-party insurance because evidence of their safety and efficacy is lacking. And two physicians, including one of the primary authors of the original February 2007 bulletin, have said that the threat of losing that insurance money was behind the change in wording. “I think ACOG was choosing to protect its clinicians’ insurance incomes over patients’ well being,” said urogynecologist Dr. Anne Weber.
Dr. Anne Weber, the urogynecologist and former head of the NIH’s pelvic organ disorder program said that as the prolapse bulletin’s lead author, she vehemently opposed the change in wording. “I think ACOG was choosing to protect its clinicians’ insurance incomes over patients’ well being,” she said in an interview.
Dr. Wall, the St. Louis urogynecologist, warned in his January 2010 article that “powerful commercial interests are reshaping the field of pelvic surgery.” The ubiquity of the vaginal mesh “kits,” he wrote, “hold out the promise of quick, easy, standardized operations; higher surgical volumes; and increased profits for both the surgeon and the device manufacturer.”
In a separate article on commercial pressures and ethics, Dr. Wall (a co-petitioner on Public Citizen’s call for a ban on vaginal mesh for prolapse) offers his analysis of ACOG’s revised practice bulletin:
“What is wrong with the new language? The experimental nature of these procedures has not changed; rather, in altering the text in this way, the ACOG Committee on Practice Bulletins shifts the responsibility for using these procedures from the surgeon (who should be acting as the patient’s fiduciary) to the patient herself, as if the signing of an “informed consent” document would be some kind of “universal disinfectant” that absolves the surgeon from any responsibility for what might happen afterwards.”
ACOG’s original response came in the form of a letter published after Wall’s article. Hal C. Lawrence III, then ACOG’s vice president of practice activities (now the group’s executive vice president) wrote, in part: “Shortly after Practice Bulletin 79 was published, the College received e-mails, letters, and phone calls from ACOG Fellows who objected to the use of the word ‘experimental’ to describe the anterior and posterior vaginal prolapse surgeries. Their concerns centered on the ambiguity of the word ‘experimental’ and their perception that ‘experimental’ did not accurately reflect the wide acceptance of these surgeries.” Lawrence rejected Wall’s argument that financial or insurance considerations were at the heart of the decision.
But Dr. Lawrence’s letter drew this published response from Dr. Weber: “In fact, the ACOG staff member at the meeting of the Committee on Practice BulletinsGynecology described the real reason for concern: ‘…recognition that the current wording would possibly deny payment for some physicians.’ Most of the clinicians who objected to the use of the word ‘experimental’ understood only too well exactly what meaning was intended that the use of mesh kits as procedures for prolapse lacked sufficient evidence of risk versus benefit to adequately counsel patients as to expected outcomes. Such clinicians were concerned that insurance companies would not cover procedures labeled experimental, and they were concerned about their medicolegal risk should a complication arise in the course of procedures labeled experimental.”
I called ACOG for an updated response. A spokesperson sent me this email: “The word ‘experimental’ was interpreted differently among clinicians, and suggested to some that using surgical mesh was only permitted under the auspices of clinical trials, thus potentially affecting coding and reimbursement. Others interpreted ‘experimental’ to mean simply that its use was not standard of care. The Bulletin was revised to clarify that patients should be informed of the postoperative risks and lack of long-term outcome data.”
Weber, now a private consultant who lives in Pittsburgh, told me after ACOG published the revised bulletin, she tried to draw attention to the incident. She called a few reporters and spoke to a staffer with U.S. Sen. Herbert Kohl’s special committee on aging. The committee requested more information from ACOG, including details about financial support from the drug and medical device industry. But a spokesperson for the Senate committee said no further investigation followed.
In 2008, a year after the revised ACOG practice bulletin was published, the FDA issued the first public health alert on the “Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.”
In July, the agency updated the 2008 alert, saying 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.”
The agency cited 3,979 reports of serious complications associated with urogynecologic surgical mesh products. These adverse event reports spanned from January 1, 2005, through December 31, 2010, with 2,874 of them in the last three years. Outside experts have said the actual number of complications is likely far higher. A 2009 review in the International Urogynecology Journal cited synthetic vaginal mesh complication rates from 7% to 25% with cigarette smoking found to increase the risk of mesh erosion by up to threefold.
Last year, a clinical trial comparing vaginal mesh for prolapse to traditional surgery using women’s own ligaments for repair was stopped early due to excessive complications, with more than 15 percent of patients experiencing mesh erosion. The New York Times quoted the lead author of the report, Dr. Cheryl B. Iglesia, director of female pelvic medicine and reconstructive surgery at Washington Hospital Center in the District of Columbia, saying: “The bottom line is not only there were more complications, but the mesh didn’t prove any better than traditional surgery.”
One of the key problems in the entire mesh controversy, says pelvic surgeon Samantha Pulliam, of MGH, is the criteria for selecting patients. She says in the rush to use what many thought would be a promising new device for prolapse repair, some doctors may have chosen inappropriate patients. For instance, she said, younger, fairly active women, who are still having sex and could have had alternative types of non-vaginal surgery or other treatments, were instead treated with vaginal mesh and experienced complications. “There are rare but acceptable times to use vaginal mesh,” Dr. Pulliam said. “Choosing the right patient is critical.” For instance, an older, less sexually active woman who can not have abdominal surgery or who has had recurrent prolapse after past surgeries might be a better candidate, she said.
Still, the American Urogynecologic Association put out a statement after its annual meeting Sept. 15 that the group “supports the judicious use of transvaginal mesh for [pelvic organ prolapse] repair performed only by surgeons with appropriate training on patients who have been fully informed of the risks and benefits of all available treatment options.” And a group of pelvic surgeons wrote a letter to the FDA this summer suggesting that the agency is overstating the problems with vaginal mesh. In the hands of adequately trained physicians, they wrote, and among carefully selected patients, vaginal mesh can be a useful tool.
Dr. Peter Rosenblatt, Director of Urogynecology and Reconstructive Pelvic Surgery at Mt. Auburn Hospital, a teaching hospital of Harvard Medical School in Cambridge, MA, was one of the surgeons who signed the letter. He says mesh erosion can be a “nuisance” but adds that for a minority of patients it is a serious complication. “The overwhelming majority of my patients are happy,” said Rosenblatt, who is also paid by Boston Scientific, one of the mesh manufacturers, to teach other doctors how to use the devices.
Not A Half-Court Shot, A Lay-Up
But some women with mesh complications say they simply weren’t clearly informed of the risks. Linda, a 44-year-old mother of three from South Hampton, PA is in the midst of litigation with one of the mesh makers and didn’t want her last name used. She said she went in for surgery after her bladder had dropped and was bulging into her vagina. The doctor made the procedure sound “uneventful,” she said. “He said, ‘It’s not a half-court shot, it’s a lay-up,’” she told me in an interview. Instead, Linda came out of surgery in excruciating pain, she says, with blood in her urine. She was rushed back into surgery to repair a punctured bladder. More problems followed, she said, among them: long-term self-catheterization, mesh contraction, hemorrhaging, blood clots, blood transfusions, more surgery to remove the mesh which had eroded to the point that her husband could feel it when they had sex.
Since her last surgery Linda says: “I’m leaking all the time, now I’m a pants-wetter. It’s been a nightmare.” She adds: “I’m not dying, I don’t have a terminal illness…but the last doctor I went to said ‘You’re going to be my patient for life… So, if I can get one person to not get this surgery it will be worth it.”
Kathleen, 52, of Collegeville, PA, also in the midst of litigation over mesh complications, told me she agreed to surgery on the cusp of a significant birthday. She didn’t have bladder problems, she said, but the bulge in her vagina made her feel particularly old. “I was turning 50,” she said. “I just wanted to be a better 50.”
If there’s one takeaway here, it’s this: patients must be their own most aggressive medical advocates. If you are considering this surgery, read the FDA’s suggested list of questions and take them with you to the doctor.
Amy Gezon, the Utah mom who spoke before the FDA panel, considers herself lucky. She spent about $50,000 in medical expenses and travel to get her mesh removed, and though she still has permanent scarring and recurrent pain, she says most of the mesh is now gone. She told the FDA that what has happened to aging women suffering from mesh complications is, in her opinion, “among the most egregious social injustices concerning women’s health.”