PIP Implant Scandal
1.0 Background
The breast implants produced by Poly Implant Prothese (PIP) French company were banned in the year of 2010. PIP which was founded in year 1991 and was once the world’s third largest supplier of silicone gel breast implants was eventually shut down within the same year. This company had illegally produced and marketed the implants using unauthorized industrial grade silicone gel that meant for use in mattresses instead of approved and mandated medical grade silicone gel since year 2001. The implants were widely used across Europe, Britain and South America and estimated about 400, 000 patients in 45 countries around the world with PIP Implants. The scandal was surfaced in year 2009 due to medical device reports from surgeons on the abnormally high rupture rates of the PIP implants than other approved implants. France’s drug and medical safety agency (AFSSAPS) recalled the PIP implants and advised 30,000 women to have their implants removed due to this scandal in subsequent year of 2010.
2.0 Issues with PIP implants
A full recall of PIP implants by French Ministry of Health has sparked a worldwide fear and alert. The implants with cheap and unapproved industrial grade silicone as filler are believed to have higher rupturing rates, though the exact figure varies with each health authority. According to SCENIHR , this filler could weaken the shell of PIP implants with increased risk of gel-leakage and rupture. The silicone gel filing can
The British Heart Foundation is the UK’s Number 1 Heart Charity. Their vision “is a world where people don’t die prematurely from heart disease.” They were founded in 1961 by a group of medical specialists who wanted to give money to fund extra research to find out the causes of heart diseases. They were concerned about the number of people with Cardiovascular Heart Disease who were dying prematurely. They have been going for 53 years and have been helping people since then. They have been taking part in all events but the main one which is coming up in September is the Oxford to Cambridge Bike Ride.
The Hospitals timely objected to the Implant Policy after Aetna provided notice to them of Aetna’s intent to implement the policy. Importantly, the criteria that an implant remain in the body for a specified period of time, as required by the Implant Policy’s definition of “Implantable Devices,” is not present in the NUBC’s definition of “Other Implants” for use of revenue code 278. Indeed, the NUBC considered Atena’s proposal to add a requirement that the implanted device remain in the body for at least six months to the definition of “Other Implants” and rejected it.
Total joint replacements are very common in the United States, and are becoming even more common with increasing obesity rates and an increase in life expectancy. Long-lasting and high-performance implants are needed for the younger, active population that receives them. The Agency for Healthcare Research and Quality states more than 285,000 total hip arthroplasties (THA) and 600,000 total knee arthroplasties (TKA) are performed in the United States alone each year (2). Longevity of these joint replacements is dependent on several factors: the durability of the fixation of the implant surface to the bone, the bearing surface’s wear rate, and the accuracy of the surgeon in implantation of the total joint (2). Of these total joint replacements, periprosthetic osteolysis and aseptic loosening occurs in about twenty percent of cases, and aseptic loosening is responsible for about seventy-five percent of total joint replacement failures (2). This is
In the event of a tear or rupture, the thicker gel used when creating gummy bear breast implants makes the gel less likely to extrude from its shell and enter the surrounding
Biomaterials, whether from natural or synthetic origin, have been used for many biomedical applications ranging from surgery to drug delivery (1). Of particular interest is the use of silicone products for breast implants, which are medical prostheses serving to augment or reconstruct breasts (1). To date, silicone is one of the most commonly used materials for plastic surgery procedures in North America (1, 2). The first silicone breast implants were developed in 1961 and were available for use by 1962. At that time, there was limited awareness on the safety and efficacy of silicone in breast implants, but this view changed when attention was drawn to repeated reports involving adverse reactions after implantation (1, 3-5). This led to a moratorium on silicone breast implants in 1992 by the US Food and Drug Administration (FDA) (5). After extensive research, the majority of results concluded that there were no major harmful effects associated with silicone products. In 2006, FDA approved the use of silicone products in breast implants, which currently leaves silicone as the only available material for this purpose (3, 5, 6). Since that time, there has been controversy around the nature and associated complications related to silicone products in breast implants (1, 2, 5). This is reflected by the current body of literature, and seems to result from a lack of consistency in the methodologies used to determine the mechanisms underlying silicone transport, uptake,
Private cosmetic surgery clinics claim that the local administration has a "principal liability" to bear expenses for secondary surgery to replace the PIP implants, since health officials did not discover the problem.
Over the past 20 years there has been many high profile cases both with children and with adults that has resulted in Enquiries and Serious Case Reviews Some of these cases have received heavy media attention and have shaped quality assurance, policy, regulation and inspection is completed and conducted.
In the early 1960’s Dow Corning supplied Texas plastic surgeons Frank Gerow and Thomas Cronin with silicone for their medical implant device research. Gerow and Cronin, using Dow Corning silicone, invented the first silicone breast implant as a device to aid women who had undergone mastectomies. At that time, the Food and Drug Administration had no regulations governing implantable devices. Companies like Dow Corning had to determine the safety of devices on their own. The surgeons conducted clinical trials of the implant prior to product introduction in 1964. In the next several years, the implant grew popular for cosmetic surgery as well as reconstructive, and Dow Corning cornered both markets. Between 1960s and the mid-1990s, about two million women nationwide have received breast implants, most of them for cosmetic reasons. However, some women have started to complain that the implants have ruptured, allowing gel to leak into the breast cavity and migrate to other
Internal fixation devices in the past had been made of stainless steel or titanium, but with problems resulting from those permanent devices, an innovative approach is being considered. Bioresorbable implants are a possible replacement to the original implants that would eliminate the need for removal, which has shown to be a problem for traditional implants.
There are several confusing topics for women when it comes to their breast health such as how often they should be screened with a mammogram, what age to start getting their mammograms, or how often they should have a mammogram. One of the newer discussions that has emerged recently is if women should be told that they have dense breast tissue. Several states have even moved a step further and are mandating that women be told this information. I believe that the states should go beyond this when passing the law and require insurance companies to pay for supplemental testing of these women who fall into this category and have additional risk factors.
The first piece of propaganda that is used depicts a few British citizens behind the British flag, with an outline of the country on it. One of the types of persuasion it uses is the bandwagon appeal, which convinces others to join or do whatever the propaganda is suggesting, because others are doing it. Patriotism is used as well. Great Britain's flag and the country itself is on the paper, making it patriotic.
It is an unfortunate fact that there are a countless number of women that are unsatisfied with their appearance. In particular, it is common for women to be dissatisfied with the size of their breasts, and whether this stems from genetics or the result of a mastectomy, it can create some self-esteem issues. Fortunately, there are breast enhancement procedures that you can use to create the look that you want for your body. Deciding to undergo this cosmetic procedure is a serious decision, and you will likely need these questions answered before you are able to decide about this procedure.
The recent push for approval of silicone implants is particularly problematic. Doctors and patients often prefer the silicone implants because they more closely mimic the look and feel of breast tissue ((1)). Although there is little evidence supporting the claims made against silicone breast implants in the 1980's (which said that they contributed to autoimmune and connective tissue disorders), it can be said that silicone implants cause more problems than saline implants. When a saline implant ruptures, it deflates almost immediately, creating visible evidence of the problem ((1)). Silicone implants may show symptoms of rupturing, but many women have a "silent rupture" in which the scar tissue around the implant holds in the saline gel. Since these women have no symptoms, the only way to identify the rupture is through MRI ((5)). What makes this particularly alarming is that the long term effects of having the silicone gel sitting indirect contact with scar and breast tissue is unknown, which is one of the reasons that the chairman of the FDA advisory panel, which voted in favor of approving silicone implants, asked that the FDA ignore the panel's advice ((6)). Long term safety of silicone implants has simply not been demonstrated by any studies presented to the FDA, yet many in the
new advancements such as microchip implant for humans and animals can be very controversial. At first, the implants may seem to have benefits but in the long run they will actually cause more trouble than they are worth. These potential "troublemakers" are about the size of an elongated grain of rice and are injected in the skin under the arm or hand (Feder, Zeller 15). The chip is not powered by battery and there is nothing that can possibly leak out into the body (Posada-Swafford 8). An early form of this technology was used to monitor salmon and has been used for other wildlife research (Verhovek 5). The idea of the chips was started from the September 11 tragedy
Comprised of various short stories about Ernest Hemingway’s early life and career, A Moveable Feast presents his time in Paris during the 1920s. This autobiography recounts Hemingway’s memorable adventures in Paris following World War I, beginning when he first moves to the city with his wife and ending when he has an affair with someone else. Through the course of the novel, Hemingway finds his true passion in writing. Among countless distractions from his fascination, Hemingway consistently documents his daily situations, regardless of the circumstances.