Due to the widely fragmented market, supplier power is low in the Indian plastics industry. This is because of the presence of many suppliers relative to the overall size of the industry segment that leads to high levels of competition, which in turn tends to keep average profit margins at a modest single digit level except for those firms that specialise in custom-made products. Commenting on the market scenario of plastics and polymers, JayeshRambhia, Vice President, All India Plastic Manufacturers Association, avers,“In India, almost 8 kg of plastic is used per head as against 45 kg per head in Western countries. Thus, the use is less over here.”
Unlike prescription drugs, which must be proven safe and effective before they are marketed, most medical devices have no such requirement. Only about 10 per cent of devices, those deemed the riskiest, such as breast implants and implantable pacemakers, fall into that category.
Thus, problems are sure to occur. There are growing concerns about the government process that allows devices such as surgical mesh, made of the same material as rubbermaid storage containers, to be used with no testing on patients before they are actually allowed on the market.
According to the advisors to the Food and Drug Administration (FDA), the trouble-prone medical products widely used to surgically repair women’s pelvic problems need stringent testing for safety and effectiveness. The advisory panel has urged the FDA to reclassify plastic surgical mesh that is used to repair pelvic collapse. This consensus recommendation indicates that if the FDA agrees, the concerned manufacturers would be required to prove the safety of the products. FDA has received reports of complications associated with the mesh. The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels.
With age, inactivity and sometimes disease, muscles throughout one’s body may become flabby, weak and are unable to support the body structure. The muscles of the pelvic floor are no exception. Pelvic muscle weakness can result in incontinence (an inability to control your bladder or bowels) and/or prolapse (the dropping of the uterus, the bladder, and/or the rectum within the vagina or past the vaginal opening). Prolapse may be caused by inadequate muscle tone. This usually results from childbirth, but there may be other causes. Obesity is one of the causes for the problem to arise. According to a recently released report approximately one-third of the US women will have pelvic health problem by the age of 60. The report, funded by the non-profit National Women’s Health Resource Center, has been submitted by the Lewin Group, a healthcare consulting firm.
More than a half-million women undergo surgery for so-called pelvic prolapse and incontinence each year, though not all procedures involve mesh. About 75,000 women had prolapse surgery with mesh inserted through the vagina last year, and more than 200,000 women had the procedure for incontinence. Various companies manufacture the plastic mesh that is used to strengthen the pelvic wall in cases of stress urinary incontinence and pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. Using a small surgical incision, the mesh is often inserted through the vagina. And many doctors prefer this method to abdominal placement, which requires a larger incision. Dr ManjulaAnagani, Senior Consultant Gynaecologist & Obstetrician & Laparoscopic Surgeon, Beams Hospitals, Hyderabad, elaborates, “Usually for Indian women using mesh is the last resort. People generally try to avoid these procedures by either medication or pelvic floor exercises and many other processes. Mesh is used as a sling to prevent urine coming out unnecessarily when there is a stress like coughing or sneezing. It becomes embarrassing for her then.” She adds that these are the common occurrences usually in the menopausal age group.