Category Archives: In The News

FDA Aims To Speed Clinical Trials, Improve Device Safety Through Post-Market Evaluation, But Funding A Hurdle

February 16, 2016, Inside Health Policy

FDA’s device center chief Jeff Shuren, in an interview with Inside Health Policy, highlighted the benefit a robust National Device Evaluation System could have in bolstering the agency’s ability to monitor devices in real-time to better inform the risk-benefit profile of approved products. Such a system, he said, could also help in the premarket approval phase to reduce the clinical trial burden on manufacturers and get products to market faster.

The program is a high priority for the Center for Devices and Radiological Health within FDA. It was recently listed in CDRH’s 2016-2017 priority agenda, and FDA in the fiscal 2017 budget requested $1.8 million in funding to help establish the system as part of President Barack Obama’s Precision Medicine Initiative. The agency will hold a public workshop in March on the effort.

The goal for FDA, according to Shuren, is to move past the traditional scope of a national surveillance system and launch a program that would allow the agency to more accurately track and analyze the use of medical devices in a real-world setting and better understand the benefits and risks of specific products outside of the clinical trial setting.

[…]

Sources point to a lack of funding as a main reason for FDA’s inability to effectively monitor medical devices in the postmarket setting. Some stakeholders pointed to the disparity in user fees between the drug and device centers as a main reason for the lack of available resources, but others defended the amount of money the device industry currently provides as reflective of the gap in market caps between large manufacturers and smaller device start-ups.

Sources say industry is lukewarm on providing additional resources for postmarket in the pending user fee reauthorization agreement, which has led patient and consumer groups to turn their attention to Congress in the hopes that additional funding for the agency’s postmarket goals will be included in next year’s spending bill.

“I think more money is problem number one and without more money the agency is never going to do a good job,” Diana Zuckerman, president of the National Center for Health Research, told IHP.

Stakeholders have suggested the medical device user fee process is more difficult to navigate than the sister program in the drug center, given the financial disparity in the medical device industry between the large corporations and smaller start-ups. Zuckerman, however, argued that no one is expecting a small device company to pay millions in user fees to cover something like postmarket surveillance.

“There are many small companies and, yes, small companies should have user fees that are affordable, but the medium, large and extra-large sized device companies could be paying a lot more,” she said.

Johnson & Johnson, for example, pays roughly $2.4 million in user fees for a new drug application, sources say, and only $5,000 for a 510(k) submission. A spokesperson for J&J did not respond to inquiries.

Increasing the amount of user fees for the large companies, sources say, could help fund FDA’s postmarket surveillance goals. Sources familiar with the user fee discussions tell IHP, however, that the medical device industry, in particular the Advanced Medical Technology Association, has rejected the notion that industry should have to pay more for faster approvals.

[…]

To read the full article, click here.

FDA to Create Early Warning System for Medical Devices

BY ROBERT LOWES, MEDSCAPE

DECEMBER 31, 2015

Hammered for its regulation of medical device safety, the US Food and Drug Administration (FDA) today proposed telling the public about “emerging signals” of possible device risk before it determines whether the risk actually exists.

Such early warnings already are issued for drugs through the FDA Adverse Event Reporting System (FAERS), a database on adverse event and medication error reports submitted to the agency. A dramatic fall-off in the number of drugs flagged for potential risk signals in FAERS since 2012 prompts FDA critics to wonder whether a similar system for medical devices will benefit the public.

In today’s proposal, the FDA explained that it historically has alerted the public about safety concerns that crop up after a device goes on the market, and usually after it has determined what to do about them. Agency responses include recommendations for the “device user community” and possible regulatory action.

However, the FDA said there is a need to notify the public “about emerging signals that the agency is monitoring or analyzing, and for which the agency does not yet have specific recommendations.”

[…]

Diana Zuckerman, PhD, president of the National Center for Health Research, a think tank focused on children and adults, said she does not believe that the downward trend line means that the FDA has been receiving fewer adverse event reports. Rather, the process of disseminating possible risk signals has become “moribund.”

“We think FAERS information is not being made public in a timely manner,” Dr Zuckerman toldMedscape Medical News. She cites lack of regulatory and political will as the reason. FDA user fees collected from drug manufacturers “are dependent on speed of review for drug approvals, not on timely FAERS information,” she said. “Similarly, Congress has complained about the speed of drug and device approvals, not on the speed of warning safety signals.

“Unfortunately, safety is not currently a priority at the FDA or Congress,” Dr Zuckerman said.

[…]

Read the full article here.

Next steps for breast implant–associated anaplastic large-cell lymphoma

Anna E. Mazzucco

Journal of the American Society of Clinical Oncology, June 16, 2014

To the Editor:

The excellent analysis by Miranda et al1 based on extended follow-up of patients with breast implant–associated anaplastic large-cell lymphoma (ALCL) adds to the mounting evidence of the potential for aggressive clinical behavior of this disease.2,3For the first time, these researchers identified two patient subpopulations with distinct clinical outcomes: 75% of the patients with solid ALCL tumors had survived at 5 years postdiagnosis, compared with 100% of patients with effusion-type ALCL. In contrast, earlier studies suggested that breast implant–associated ALCL was likely to be clinically indolent and more similar to primary cutaneous, anaplastic lymphoma kinase (ALK) –negative ALCL, rather than the more aggressive systemic form of the disease.4,5

Although ALCL is rare, breast implants increase the risk by an estimated odds ratio of 18.2.6,7 Miranda et al1 found aggressive ALCL and potential mortalities associated with either saline or silicone-filled implants in both cosmetic and reconstruction patients, and point out that the lack of routine pathology examination of seroma or excised tissue could result in an underestimation of ALCL occurrence. Extrapolating from their findings, the lack of routine pathology is likely to delay the diagnosis when women with implants seek medical care from plastic surgeons or primary care physicians for swollen breasts that are assumed to be infected.

Timely diagnosis will depend on the millions of women with breast implants having access to heightened surveillance, knowledgeable physicians, and appropriate testing and medical care. All of the ALCL cases described in Miranda et al1 were ALK negative, which has a poor overall prognosis and is treated with cytotoxic chemotherapy.8 Others have proposed that all seromas associated with implants, especially those which are therapy resistant, should therefore be carefully monitored, and any patient presenting with recurrent seroma 6 months or more after implantation should undergo aspirate analysis without delay.9,10 The question is, how can such monitoring be ensured?

The track record for monitoring the health of patients with breast implants is not encouraging, however. For example, the US Food and Drug Administration recommends that all women with silicone gel breast implants undergo regular magnetic resonance imaging scans starting 3 years after implantation to check for implant rupture, but most insurance policies do not cover such screening; therefore, few women follow these guidelines. Moreover, many health insurance policies currently exclude any services related to complications from cosmetic surgery; this excludes the approximately 75% of women whose breast implants were originally for cosmetic purposes rather than reconstruction after mastectomy. Our research center’s recent review of health care policies under the Affordable Care Act found no evidence that the growing literature on breast implant–associated ALCL has influenced health insurance coverage for either cytology cultures of seroma or removal of breast implants and capsules that are causing ALCL.

Future studies are needed to elucidate what factors determine whether specific types of breast implants are more likely to increase the risk of ALCL, particularly solid tumors. The collaboration between the US Food and Drug Administration and the American Society of Plastic Surgeons to create a registry of implant recipients who develop ALCL should provide useful information. As new data become available, they should quickly be used to improve early diagnosis and treatment. That will require insurance coverage of medically necessary services for women with serious breast implant complications, including those with implants originally for cosmetic purposes.

See the article here.

References:

  1. Miranda RN, Aladily TN, Prince HM, et al. (2014) Breast implant–associated anaplastic large-cell lymphoma: Long-term follow-up of 60 patients. J Clin Oncol32:114–120. Abstract/FREE Full Text
  2. Carty MJ, Pribaz JJ, Antin JH, et al. (2011) A patient death attributable to implant-related primary anaplastic large cell lymphoma of the breast. Plast Reconstr Surg 128:112e–118e. CrossRefMedlineGoogle Scholar
  3. George EV, Pharm J, Houston C, et al. (2013) Breast implant-associated ALK-negative anaplastic large cell lymphoma: A case report and discussion of possible pathogenesis. Int J Clin Exp Pathol 6:1631–1642. MedlineGoogle Scholar
  4. Aladily TN, Medeiros LJ, Alayed K, et al. (2012) Breast implant-associated anaplastic large cell lymphoma: A newly recognized entity that needs further refinement of its definition. Leuk Lymphoma 53:749–750. CrossRefMedlineGoogle Scholar
  5. Ralfkiaer E, Willemze R, Paulli M, et al. (2008) in Tumours of the Hematopoietic and Lymphoid Tissues (ed 4) Primary cutaneous CD30 T-cell lymphoproliferative disorders, eds Swerdlow SH, Campo E, Harris NL, et al.(International Agency for Research on Cancer, Lyon, France), pp 300–301. Google Scholar
  6. US Food and Drug Administration. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses, 2011.http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239996.htm.
  7. de Jong D, Vasmel WL, de Boer JP, et al. (2008) Anaplastic large-cell lymphoma in women with breast implants. JAMA 300:2030–2035. CrossRefMedlineGoogle Scholar
  8. ten Berge RL, de Bruin PC, Oudejans JJ, et al. (2003) ALK-negative anaplastic large-cell lymphoma demonstrates similar poor prognosis to peripheral T-cell lymphoma, unspecified. Histopathology 43:462–469. CrossRefMedlineGoogle Scholar
  9. Kim B, Roth C, Young VL, et al. (2011) Anaplastic large cell lymphoma and breast implants: Results from a structured expert consultation process. Plast Reconstr Surg 128:629–639. CrossRefMedlineGoogle Scholar
  10. Taylor KO, Webster HR, Prince HM
    (2012) Anaplastic large cell lymphoma and breast implants: Five Australian cases. Plast Reconstr Surg 129:610e–617e. CrossRefMedlineGoogle Scholar

Psst! Industry has taken over FDA

By Jim Dickinson, Medical Device and Diagnostic Industry
September 17, 2015

Just six years ago, the industry-at-arm’s-length tradition held sway—as it had throughout FDA’s history—when Califf was passed over in Obama’s hunt for a commissioner.

The reason? The Duke University researcher of numerous drug industry clinical trials was then viewed as being too close to the pharmaceutical industry—the same reason that had for decades kept other similarly situated candidates from being chosen to lead the world’s premier health regulatory agency. New York health commissioner Margaret Hamburg was chosen instead.

[…]

No matter how sincere a commissioner might be—and Hamburg was—in divesting him or herself from all potential appearances of possible conflicts of interest before taking on the job, suspicions will linger in the minds of people and groups ready to provoke investigations that cost taxpayer dollars.

That is exactly what seems to be developing in the case of Califf’s nomination.

In a press release, Public Citizen said the Senate should reject it because of Califf’s close ties with industry over the years. “During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few,” the group said. “Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed.”

Echoing similar concerns, National Center for Health Research president Diana Zuckerman said Califf could have a bias toward industry after working in tandem with companies that funded clinical research at Duke.

When Califf joined the agency last February as deputy commissioner for medical products and tobacco—a step widely seen as grooming him to become commissioner—Zuckerman told Time that his “interdependent relationships” may bring into question his “objectivity and distance.” In the Time article, she pointed out that research has shown that scientists may unknowingly be swayed by their industry relationships.

Read the full article here.

21st Century Cures drug bill triggers a DC dust-up over relaxed development regs

By John Carroll, Fierce Biotech
July 10, 2015

Lawmakers in the House easily passed the 21st Century Cures Act today, a big step toward once again shaking up the legal framework built to guide drug development in the U.S. while significantly boosting the amount of funding that flows to the NIH.

As for the $9 billion being earmarked for the NIH–which comes along with more funding for the FDA–after years of research budget stagnation, there’s virtually no debate. The bill’s authors have found a way to pay for that by reining in some spending to Medicare prescription drug plans and selling off some of the crude oil in the country’s stockpile, and Democrats are being won over by the notion of increased federal spending for more precise medicines. Research groups in the industry and academia are pushing this hard, and finding open arms in the capitol.

The political trip wire in the bill centers on changes to the way drugs and devices are developed and approved. Among the provisions in the bill, regulators would be given the authority to approve new antibiotics based on preclinical testing combined with small human trials. Biomarkers and other so-called surrogate endpoints could be used more easily to approve new drugs, offering developers a shorter clinical path to developing a drug. And the bill strips away some requirements for reporting physician payments from pharma companies, if they’re associated with education–a very broad categorization. […]

Consumer advocates, though, see the new development regulations as a recipe for unleashing drugs and devices that would later prove dangerous and unhelpful.

“The irony is calling this 21st Century Cures, when they’re talking about standards that were left behind in the 20th century, because they were found to not be good,” Diana Zuckerman, president of the National Center for Health Research, tells the Washington Post.

But there’s also been notable opposition from some well-known experts in the field who aren’t in the least bit happy about a switch in rules that would devalue the current gold standard for clinical development, which relies on randomized, well-controlled drug studies. Harvard’s Jerry Avorn, for example, has a problem with “shorter or smaller clinical trials” for devices as well as new criteria for relying on “evidence from clinical experience,” including “observational studies, registries, and therapeutic use” that could be used to allow for new uses of approved drugs. “Although such data can provide important information about drug utilization and safety once a medication is in use, there is considerable evidence that these approaches are not as rigorous or valid as randomized trials in assessing efficacy,” Avorn writes.

“In our rush to find new effective treatments, we should not harm our patients with ineffective toxic ones,” writes JAMA editor Rita Redberg. That’s the line that marks the boundary between supporters and opponents of the bill.

Read the full story here.

Breasts, buttocks and botox – the surprising trends in plastic surgery

The American Society of Plastic Surgeons (ASPS) released  the detailed figures on cosmetic surgery in 2014, and Euronews outlined seven surprising trends from the US. Among them:

Men and boys having their ‘breasts’ reduced

The number of male teenagers in the US going under the knife for breast reduction in 2014 rose to 6,694, up 14 percent compared with the previous year.

The proportion of obese US teenagers (aged 12-19) has ballooned from 5 percent in 1980 to 21 percent in 2012, according to the Centers for Disease Control and Prevention.

There was an identical trend with adult males: 26,175 underwent surgery to have their ‘breasts’ reduced in 2014, up 14 percent compared with 2013.

Teenagers going under the knife

The number of US teenagers putting themselves forward for cosmetic procedures is on the rise – 224,000 13-19 year olds had work done on them in 2014, a jump of 2 percent on the previous year.

The most popular jobs were nose reshaping, male breast reduction (see above), ear surgery, laser hair removal and laser skin resurfacing.

ASPS says parental consent is required for operations on teenagers under 18.

Diana Zuckerman, president of the National Center for Health Research, said: “There is no question that reconstructive surgeries can benefit children and youth. Surgical procedures to correct cleft lips and palates, for example, are not controversial. Plastic surgery to correct unattractive facial features that can attract ridicule, such as prominent noses and ears, are generally accepted in the United States.

“However, cultural phenomena such as surgical makeovers on numerous television programs and unrelenting pressures on teens to conform to beauty standards make it increasingly difficult to agree on what constitutes a “normal” appearance and when the desire to improve one’s appearance is questionable or even crosses the line to psychopathology.”

Read full article

Bill to Speed Approvals for Drugs Is Cut Back

By Sabrina Tavernise, New York Times
April 30, 2015

WASHINGTON — Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.

The draft bill presented at a hearing in the House on Thursday represents a less aggressive streamlining of the drug approval process, critics of the earlier draft said, and seems to have secured strong bipartisan support.

The legislation, called 21st Century Cures, has been in the works for months. Its lead sponsor, Fred Upton, Republican of Michigan, said it would speed the pace of drug cures by removing unnecessary hurdles from the regulatory process.

Critics, including top officials at the Food and Drug Administration, had expressed concern that the changes would risk patient safety — for example, by potentially permitting shorter clinical trials and letting drug companies use alternative measures of health as evidence of a drug’s effectiveness and safety.

The bill’s supporters said it was a work in progress that had been assembled in one of the most collaborative, transparent processes Congress has seen in years. The sponsors held eight hearings and more than a dozen round-table meetings in districts across the country to gather comment.

“We have a chance to do something big, and this is our time,” Mr. Upton said.

His co-sponsor, Diana DeGette, Democrat of Colorado, said the lawmakers had made “tremendous progress,” recalling “that hokey video” that she and Mr. Upton made to promote the effort last year.

The draft — at about 200 pages it is half its former size — seemed to allay fears among some experts that it would fundamentally rewire the way drugs are approved. Earlier proposals to give drug companies broad powers to promote their products for uses other than the approved ones and to market brand-name drugs for a longer time without generic competition were not included.

The F.D.A. has defended its record for drug approval speed, saying that in 2014, it approved the most new drugs in almost 20 years, and that it moves faster than its counterparts in other wealthy countries. Experts note that pathways exist for expedited approval, and that the F.D.A. is held to relatively strict timelines under other rules set by Congress. Instead, they say, the bottleneck for new drugs is often a matter of the years of research it takes to find them.

Diana Zuckerman, the president of the National Center for Health Research, said earlier versions of the legislation had “considerable micromanaging of the F.D.A. and enormous power given to industry.”

She added, “Most of that is gone.”

But she cautioned that the bill still held numerous provisions she believed put people at risk, including ones she described as lowering standards for the approval of medical devices and antibiotics. The bill would increase the work the F.D.A. must perform, but not the money it receives, and Dr. Janet Woodcock, an agency official who testified Thursday, said that was a concern.

“We are very stretched in our resources,” she said.

One point that is likely to concern the F.D.A. is a provision that would reduce its authority to regulate some software associated with medical devices.

An earlier version of the bill would have let drugmakers use quicker measures for a drug’s effectiveness during testing — for example, changes in blood sugar level instead of a more final outcome, like development of diabetes. The new draft instead suggests ways the F.D.A. could use those alternative measures, called biomarkers.

The F.D.A. says it already uses them in a substantial share of drug approvals, and Dr. Woodcock told the lawmakers Thursday that the agency did not need additional authority on this count. Progress has been slow in adopting more biomarkers, she said, because they often did not produce enough evidence to allow scientists to draw firm conclusions.

“You have to know those biomarkers are reliable before you can take a chance on a human life,” she said.

See the original article here.

What Do Stakeholders Think Of FDA’s Latest Effort To Get Patients Timelier Access To Devices?

By Michael Williamson, Bloomberg BNA

The FDA April 8 released two final guidance documents that will help provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs, Jeffrey Shuren, the director of the agency’s Center for Devices and Radiological Health, said in a blog posting.

Reaction to the two documents is mixed – pitting industry against some patient advocates.

One guidance document describes the FDA’s Expedited Access Program (EAP), which should “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions” without compromising the agency’s high standards for safety and effectiveness, Shuren’s blog posting said. The other guidance document outlines the agency’s current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. In addition, the document addresses whether or not the circumstances when postmarket data collection is appropriate for PMAs meet the criteria for the EAP.

Two stakeholders seemed pleased with the EAP document. The Advanced Medical Technology Association (AdvaMed), “commends the agency for its efforts to explore supplementary review pathways to provide more timely patient access to new technologies for life-threatening or irreversibly debilitating diseases or conditions that addresses an unmet medical need,” Janet Trunzo, the association’s senior executive vice president for technology and regulatory affairs, told me in a April 9 e-mail.

In addition, Ben Moscovitch, officer with the medical device project of the Pew Charitable Trusts, a nonproft policy organization, told me April 9 many of the recommendations his group made on the draft version of the EAP document were included in the final document. For example, he told me that the EAP final guidance document reflects a Pew suggestion from 2014 that the FDA should require the initiation of postmarket trials and completion of those studies within a certain timeframe.

Not everyone is pleased with the guidance, however. The EAP final guidance “is part of a larger problem where the FDA is bowing to pressure from Congress to weaken safeguards that are intended to protect patients from unsafe medical products,” Diana Zuckerman, president of the National Center for Health Research, told me in an April 9 e-mail. She is also president of the Cancer Prevention and Treatment Fund.

See the original article here.

Breast Implants In France To Carry Cancer Warning: Researchers Find A ‘Clearly Established Link’

By Dana Dovey, Medical Daily

March 18, 2015

Following France’s National Cancer Institute finding a “clearly established link” between breast implants and a specific type of cancer, the country will now order all breast implants to come with a cancer warning. This announcement came after 18 cases of anaplastic large cell lymphoma were directly linked to women with silicone breast implants since 2011.

Anaplastic large cell lymphoma (ALCL) is a type of non-Hodgkin’s lymphoma that affects the blood. The link between breast implants and this form of cancer is extremely rare, so French officials have urged women who already have the implants not to remove them, the Daily Mail reported. Given the severity of the cancer in the few women who do develop it, French officials felt it necessary to inform women of all the possible risks associated with the surgery.

ALCL is extremely rare, affecting around one to six in every three million women who undergo breast augmentation, Medical News Today reported. However, a study conducted by researchers from Cambridge University in the UK found that nearly all cases of ALCL in breasts occurred in patients who had undergone breast augmentation, suggesting a link between the two. Although it’s not clear why silicone breast implants can sometimes cause cancer, the Cambridge investigation did shed some light on the mystery.

“It’s becoming clear that implant-related ALCL is a distinct clinical entity in itself,” Dr. Suzanne Turner, lead researcher of the Cambridge study, told Medical News Today. “There are still unanswered questions and only by getting to the bottom of this very rare disease will we be able to find alternative ways to treat it.”

Breast implants are a very popular surgery, with Dr. Diana Zukerman, president of the National Center for Health Research, explaining that in 2013 alone 300,000 American women opted for the operation. Of these women, around 80 percent undergo breast enhancement for cosmetic reasons while a further 20 percent have breast implants following breast cancer.

This is far from the first time that breast implants have been implicated in causing a health hazard. In 2011, French firm PIP caused global hysteria when plastic surgeons reported an abnormal amount of the implants rupture, the Daily Mail reported. It was later found that the firm had been manufacturing these breast implants using industrial grade silicone intended for use in mattresses.

The implants were subsequently found faulty and banned from use. Women who had already received the implants were advised to have them removed, although European health officials found no medical or toxicological evidence to back this advice.

See original article here.

The rising trend of breast implants in America

Below of is the transcript of a TV interview that aired on BBC Persian on April 3, 2013. To view the segment (in Farsi) click here.

With 330,631 breast augmentation procedures performed in the United States in 2012 alone, America is now officially the global leader in this branch of cosmetic surgery and breast implants are now the second most popular plastic surgery in the world.

Why have breast implants become so popular? In part, this may be due to the growing consumer confidence with advancements in implant technology and surgical procedure:

Dr. Byron D. Poindexter, board-certified plastic surgeon with The Austin-Weston Centre for Cosmetic Surgery in Reston, VA:

“We’re able to go through what’s relatively small incision down here probably about 4 centimetres at this point and you can squeeze this implant completely through with hardly any effort at all and it just comes out on the other side.”

But despite these innovations, breast augmentation remains a very intrusive and potentially risky operation. Some critics argue that that many patients are oblivious about these potential risks:

Florence Williams, author of BREASTS: A Natural and Unnatural History:

“I think the plastic surgery industry has been masterful at marketing implants and augmentation as very benign procedures It sort of in line with other procedures women get Botox, hair colouring, this is marketed as yet another way improve you image. I don’t think there is an understanding that these are major surgical procedures and that they have the inherent risks of other procedures People for example don’t realize that 1 in 6 women who get implant actually lose sensation in their nipples they also don’t understand that 1 in 5 women need a re operation because of complications within 3 years of their implants.”

Pregnancy, breastfeeding, and weight loss can also take a toll on breasts, leaving them deflated and without volume. Breast implants can bring back that lost volume, but can it make a patient feel better inside about herself and her body image?

Diana Zuckerman, Ph.D. President, National Research Centre for Women & Families Cancer Prevention and Treatment Fund:

“Self-esteem is not like having a bad hair day and a good hair day. People feel better about themselves on a good hair day than a bad hair day, but it doesn’t change their self-esteem; it doesn’t change how they really feel about themselves. And so the objective studies that have been done of cosmetic surgery–and this is true for breast implants and other surgeries–show that usually men and women who have cosmetic surgery feel better about the body part that was fixed. If their nose was changed they like their nose better, if their ears don’t stick out they like their ears better. If their breasts are larger they might feel sexier and think their breasts look nicer but it doesn’t actually change that sort of basic feeling of who they are.”

But what about cultural norms? For once, the fashion magazines aren’t to blame—if anything, they favour the flat-chested to concave look. Many major movie stars are also kinda small in the chest— so what is driving the demand?

Florence Williams:

“I think there’s no question that we live in a breast obsessed culture and in some areas that’s become less pronounced for example major movie stars but I think pornography is actually a major factor certainly there’s more availability of pornographic images now than ever before. I think a lot of young people grow up learning about the human body from the Internet this is really different. there are thousands of images of naked breast that boys and girls will see by the time they reach adulthood and so many of those breasts are not real, they’re either  digitally enhanced or surgically enhanced. So I think there’s this incredible expectation on women themselves and also from men to look a certain way.”

Mental health specialists believe anyone considering aesthetic procedure should make sure that they are doing so for the right reasons. If they are looking for a procedure because they feel society wants them to look a certain way or someone is pressuring them to have it done – it is unlikely that the operation will improve their quality of life. If however, they want to do it for themselves to feel younger when they look in the mirror, and if they have weighed in all the risks involved, then they will have a much more positive outcome — both mentally and physically.